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28 Biotech Companies Bolstering Life Sciences

These top biotech companies are impacting medical research and drug discovery.

While biotech has long been a vital component of the global tech market, this pivotal sector has seemingly reached new heights over the past decade. And although organizations around the world have tried to rule the life sciences space, the United States remains the undisputed biotech leader. 

Biotech Companies to Know

Flatiron health.

According to reports , the nation’s life sciences sector alone generates over $112 billion in revenue. In light of biotech’s mounting economic impact, it’s no surprise that tech hubs across the country are witnessing a surge in life sciences companies , bolstering the nation’s status as a biotech epicenter.

Over the past couple years, the importance of the biotech industry has been even further amplified, as the world raced to create a COVID-19 vaccine.

While focus has been on combating COVID-19, the country’s biotech leaders continue to dedicate themselves to addressing other pressing medical issues. Backed by teams of world-renowned scientists and technologists, these organizations are addressing challenges across the healthcare spectrum. Whether they’re formulating new cancer treatments or harnessing the power of human genetics, the nation’s biotech companies are making a monumental impact on the future of medical research and drug discovery. 

We’ve rounded up the top biotech companies to give you a glimpse into the burgeoning life sciences sector.

Novo Nordisk

Location: Bagsværd, Denmark

Novo Nordisk has been around since the 1920s, and today focuses on developing treatments and pharmaceuticals for chronic illnesses such as diabetes and hemophilia. The company has roughly 860 research and development employees working in the United States and is conducting clinical trials in more than four dozen countries.

Location: Boston, Massachusetts

Biotech firm Asimov is a genetic design company. It uses machine learning, computer-aided design and a niche of biology known as synthetic biology — a field that redesigns existing organisms for new uses — to genetically engineer therapeutics like biologics and gene therapies. Asimov markets a platform that includes host cells, a genetic parts library, technical guides and design software for creating genetic systems in various types of cells.

Location: Menlo Park, California

GRAIL is on a mission to detect cancer at earlier stages so that it can be more easily cured. The company focuses on seeking cancer signals in the blood, guided by the belief that tumors release cell-free nucleic acids into the bloodstream, which are thought to be a direct measure of cancer and can potentially be detected before the onset of symptoms. GRAIL intends to foster a deeper understanding of cancer biology through its high-intensity sequencing assays and population-scale clinical studies.

Schrödinger, Inc.

Location:  Cambridge, Massachusetts

Schrödinger is powering drug research with its computer simulations platform. Founded in 1990, the company employs physics-based methods to evaluate chemical matter and compounds before synthesis. As a result, researchers should see faster lead discoveries, accurate property descriptions and access to large-scale molecular exploration. The company also provides integrated data and visualization tools

Location: San Diego, California

Illumina seeks to make “genomics more useful for all, for a better understanding of human health .” The company develops products for cancer research, reproductive health, genetic and rare diseases and microbial genomics.

Location:  Lexington, Massachusetts

Founded in the 18th century, Takeda is a global pharmaceutical company with a strong emphasis on research and development. The company focuses its research in several areas: oncology, rare diseases, plasma-derived therapies, vaccines, neuroscience and gastroenterology. In the U.S. alone, Takeda has created over 50 products and service programs that benefit patients and physicians.

Viome Life Sciences

Location:  Bellevue, Washington

Viome Life Sciences believes microbial and human gene expression are altering how biological activities and human health are connected. The company uses an mRNA platform to digitize human data to prevent, diagnose and treat chronic illnesses and diseases. Through the platform, consumers can receive personalized recommendations — like dietary restrictions and exercise plans — on how to live a healthy life.

Location: San Francisco, California

Invitae provides genetic testing services, the Invitae Digital Health platform to coordinate patient care, biopharma partnerships. Its products have applications for oncology, reproductive health, pediatrics, cardiology and pathology.

Variant Bio

Location:  Seattle, Washington

Variant Bio uses innovative sequence technology and studies the genetics of individuals with “exceptional health-related traits.” The company’s goal: to transform drug development as we know it today and, ultimately, find better ways to treat diseases.

Benchling is dedicated to speeding up life sciences research through its suite of unified applications, which are housed within the company’s life sciences research and development cloud. The cloud serves as a platform for centralizing and standardizing all R&D data, enabling users to track every workflow, automatically interlink related data and easily and quickly export data. Benchling’s applications can be used for the research of antibodies, cell therapy, proteins and peptides, gene therapy, vaccines and more.

Location: San Mateo, California

Helix created an end-to-end genomics platform in an effort to enable health systems, life sciences companies and payers to advance genomic research. The company’s platform allows users to deliver actionable genetic insights and conduct large-scale genetic analyses. Helix’s Exome+ assay is designed to facilitate the discovery and analysis of rare and novel variants, genome-wide imputation, polygenic risk score calculation, ancestry inference and more.

Charles River Laboratories

Location: Wilmington, Massachusetts

Charles River Laboratories ’ focus is on the quick, efficient and safe discovery and development of drugs and therapeutics. The company provides products and services that take its clients from the basic research stage to clinical development and commercialization. Its customers come from the pharmaceutical, biotech, agrochemical, and academic sectors.

Location: Rahway, New Jersey

Merck ’s efforts center around biopharmaceutical research for preventing and treating disease in people and animals with a focus on oncology, vaccines, infectious diseases, COVID-19, cardio-metabolic disorders and discovery and development.

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Location: New York, New York

Flatiron Health aims to reinvent cancer care by learning from the experiences of cancer patients. The company’s Flatiron HC platform can help providers with administrative tasks, matching patients to clinical trials they’re eligible for and accessing patient information whenever or wherever they need.

Imagen Technologies

Imagen Technologies is dedicated to making diagnostic care more accessible while eliminating errors in radiology. The company’s FDA-cleared Computer Assisted Detection and Diagnosis software applies AI technology to medical image analysis in an effort to improve patient outcomes.

Location: Chicago, Illinois

CancerIQ is dedicated to helping providers use genetic information to predict and prevent disease. The company provides user-friendly screening tools that allow healthcare providers to offer patients easy risk assessment questionnaires in waiting rooms and track patient outcomes over time to keep them engaged and informed. CancerIQ’s screening solution enables providers to replace long paper forms and quickly identify patients eligible for genetic counseling, genetic testing or an MRI.

 Location: Palo Alto, California

BridgeBio works in medicine development for patients who have genetic diseases and cancers with clear genetic drivers. The company’s partners have included St. Jude Children’s Research Hospital and The University of Texas MD Anderson Cancer Center.

Location: Chicago, Illinois 

Neurocern aims to leverage neuroinformatics and data analytics to improve the quality of life and longevity of neurological patients. The company’s technology is designed to identify different types of dementia more effectively than other forms of diagnosis. Neurocern is guided by the belief that analytics can connect siloed markets in new ways to improve long-term care outcomes and ultimately find cures for neurodegenerative diseases.

Location: Foster City, California

Notable ’s platform aims to dramatically reduce the cost and time associated with the traditional drug development process. Powered by machine learning, automation and high-throughput flow cytometry, the company’s precision medicine platform is capable of determining which drugs or drug combinations would be most effective for specific types of cancers. Notable’s mission is to change the way clinicians and prescribers select treatments for the millions of individuals suffering from hematological cancers.

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Atomwise developed deep learning technology for the discovery of structure-based small molecule drugs. The company’s AtomNet technology utilizes a statistical approach in order to extract insights from millions of experimental affinity measurements and thousands of protein structures to predict the binding of small molecules to proteins. Atomwise’s technology removes some of the physical barriers that previously limited the success of drug discovery, and has the ability to analyze a very large chemical space to identify a small subset with high specificity for synthesis and testing.

Location: Austin, Texas

Natera is a genetic testing and diagnostics company dedicated to changing how doctors and patients manage genetic disease. The company’s solutions include personalized cancer care management, health assessments for transplant patients and women’s health testing. Natera aims to deliver technology and finely-tuned workflows that drive superior clinical and analytics performance.

ATX Therapeutics

ATX Therapeutics is dedicated to helping people more easily manage chronic health conditions such as cancer and heart disease. The company offers evidence-based digital therapeutics intervention programs, which are based on individual patients’ health history, needs and abilities. ATX Therapeutics’ programs are designed to be integrated into patient lifestyles and provider workflows to deliver a fully integrated healthcare experience.

Location: Greenwood Village, Colorado

VieCure aims to make genomic-based cancer care more accessible for patients and providers. The company’s platform operates as a point-of-care clinical decision support system that combines clinical knowledge with patient data to help oncologists generate personalized treatment plans and manage patients’ care. VieCure intends for its platform to serve as a value-added extender for every oncologist, nurse, therapist and clinical researcher.

Paige seeks to transform the diagnosis and treatment of cancer with its AI-native digital pathology ecosystem. The company’s AI suite is intended to provide data-driven insights to pathologists, clinicians and pharmaceutical teams. Paige’s aim is to propel cancer care with more powerful and efficient tools for diagnosis, treatment selection and drug development.

Location: Santa Monica, California

Quantgene aims to transform the future of medicine by unlocking the deep human genome. The company’s platform combines deep genomic sequencing and AI to detect mutational patterns of disease down to a single molecule, thus helping inform early cancer detection, prediction of disease onset and non-invasive treatment monitoring. Additionally, Quantgene’s Serenity Medical Intelligence is intended to extract vital health data from patients’ DNA so they can help protect themselves from chronic diseases, drug interactions and lifestyle risks.

Location: Cambridge, Massachusetts

Moderna is a pharmaceutical company working to use mRNA technology to develop medicines, vaccines and therapeutics. Infectious diseases, immuno-oncology, cardiovascular disease and autoimmune diseases have been among Moderna’s areas of focus.

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Strata Oncology

Location: Ann Arbor, Michigan

Strata Oncology is a genomic testing company working on precision medicine for cancer patients. The company’s StrataNGS genomic profiling test is effective for smaller tumor tissue samples compared to other tests, making testing that can inform immunotherapy decisions more accessible to patients with advanced solid tumors.

Myriad Genetics

Location: Salt Lake City, Utah

Myriad Genetics aims to provide accurate genetic insights to improve disease diagnosis, treatment and prevention. The company offers multiple testing options, including MyRisk hereditary cancer risk testing and Prequel prenatal screening.

Margo Steines and Da’Zhane Johnson contributed reporting to this story.

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Top 17 Clinical Research Organizations (CRO) in 2023

In clinical research and treatment development, clinical research organizations (CROs) are frequently a sponsor’s most important partner and ally.

Depending on the nature of the clinical trial, and your existing capabilities as a sponsor to run the trial, the CRO company of your choice will typically be responsible for facilitating most of the micro and macro processes that go into designing and running a successful clinical trial.

When contracting a CRO to help you with your trial, you are transferring over a large portion of responsibility into the hands of your clinical research partner. The CRO of your choice will have the responsibility to control a variety of factors and processes of a clinical trial, and depending on their expertise, team structures, service offerings, internal resources and many other capabilities.

Your ability to find and contract a top CRO company that is the right fit for your unique trial will be a determinant of whether or not you will be able to operate a high-quality clinical trial that meets your expected timelines, budget and delivers a top-notch patient experience.

At ClaraHealth (a patient-centric recruitment acceleration platform) , we have put together an extensive list of the top CRO companies in the US and around the world.

This is not a cro rankings list, but rather a compiled list of some of the top clinical research organizations around the world. We have highlighted their strengths and core service offerings to make it easier for you to find the right fit clinical research partner.

In addition, we’ve put together a list of 9 fundamental questions to ask the prospective clinical research organization , which will help you to save time and ensure a right fit in picking the CRO.

Formerly known as Quintiles and IMS Health, IQVIA is one of the largest CROs in the world, with a large range of service offerings to help advance clinical research.

The company was founded in North Carolina in 1982, and has since grown to over 88,000 employees in more than 100 countries.

Some clinical trial solutions offered by IQVIA include:

• Assistance with protocol design
• Design of phase 1 clinical trials
• Assessment and improvement of phase 2 and 3 clinical trials
• Site identification & selection
• Patient recruitment
• Access to global laboratories via their wholly owned subsidiary Q2 Solutions

Parexel is a global clinical research organization that was founded in 1982, and specializes in conducting clinical studies on behalf of its pharmaceutical partners in order to accelerate and ensure the drug approval process of up-and-coming potential treatments. It currently operates in more than 50 countries, and is run by more than 18,000 employees around the world.

The company has a wide range of service offerings, covering nearly every type of clinical trial service to assist sponsors in running successful clinical studies.

Some clinical trial solutions offered by Parexel include:

• Clinical trial design and development for early phase, phase 2 & 3, and late phase clinical trials
• Clinical data management
• Decentralized clinical trials
• Clinical supply chain management
• Medical writing
• Regulatory affairs consulting
• Pharmacovigilance

3. PRA Health Sciences

PRA Health Sciences is one of the largest contract research organizations in the world. Founded in 1976 under the name “Anti-Inflammatory Drug Study Group”, the company was renamed to PRA in 1982. PRA Health Sciences employees more than 17,000 people, and provides coverage to more than 90 countries.

In 2021, PRA Health Sciences was acquired by the Ireland-headquartered global CRO leader ICON, which is also reviewed in this list.

Some clinical trial solutions offered by PRA Health Sciences include:

• Decentralized Clinical Trials Platform
• Protocol Consultation & Study Design
• Onsite Support services
• Customized Solutions for Biotech (such as asset valuation, regulatory strategy, engagement and support, drug development strategy and funding solutions)
• Clinical Diagnostics
• Site Commercial Solutions
• PRA’s Laboratories for Drug Development

Headquartered in Ireland, ICON was founded in 1990 in Dublin by co-founders John Climax and Ronan Lambre. The company has since grown to be one of the largest CROs in the world. As of September 2020, the company employs more than 15,000 people in 94 locations and across 40 countries.

ICON offers clinical research services which include consulting, clinical development and commercialization across a wide range of therapeutic areas.

In 2021, ICON acquired PRA Health Sciences, which is another CRO and global leader in clinical research services.

Some clinical trial solutions offered by ICON:

• Commercial Positioning
• Early Phase
• Functional Services Provision
• Laboratories
• Language Services
• Medical Imaging
• Real World Intelligence
• Site & Patient Solutions
• COVID-19 Clinical Operations

5. Syneos Health

Formerly known as InVentiv Health Incorporated and INC Research, Syneos Health is a publicly listed and global contract research organization. The company is based in Morrisville, North Carolina, and specializes in assisting companies with late-stage clinical trials. Syneos Health currently employs more than 25,000 people, and has offices across 91 locations.

In early 2018, INC Research was acquired inVentiv Health, and the merged company was named Syneos Health.

Some clinical trial solutions offered by Syneos Health include:

• Decentralized Clinical Trials Solutions
• Bioanalytical Solutions
• Phase II-III/Phase IIIb-IIIV
• Medical Device Diagnostics
• Clinical Data Management
• Clinical Project Management
• Clinical Monitoring
• Drug Safety & Pharmacovigilance
• Site and Patient Access

6. Labcorp Drug Development (Formerly Covance)

Formerly known as Covance and renamed to Labcorp Drug Development in early 2021, this CRO is one of the largest contract research organizations in the world. The company claims to provide the world’s largest central laboratory network, and has been rated as one of the best places to work for LGBTQ+ equality by the Human Rights Campaign organization in 2018 to 2021. Currently, Labcorp employs over 70,000 people and is able to support clinical research efforts in almost 100 countries around the world.

Some clinical trial solutions offered by Labcorp Drug Development include:

• Preclinical Services
• Clinical Trials
• Clinical Trial Laboratory Services
• Post-Marketing Solutions
• Medical Devices
• Data & Technology

Also known as Pharmaceutical Product Development, PPD is a large global contract research organization headquartered in Wilmington, North Carolina. Started as a one-person consulting firm in 1985, PPD has grown to over 27,000 employees worldwide, and provides a wide range of clinical research services to pharmaceutical and biotech companies.

Some clinical trial solutions offered by PPD include:

• Clinical Development
• Early Development
• Peri- and Post-Approval
• PPD Biotech
• PPD Laboratories
• Product Development and Consulting
• Site and Patient Centric Solutions

8. Fisher Clinical Services

Part of Thermo Fisher Scientific, Fisher Clinical Services is a global clinical research organization with headquarters in Center Valley, Philadelphia.

The company has been in the business of clinical supply chain management for over 20 years, and is focused exclusively on working with the packaging and distribution requirements of clinical trials across the globe.

Some clinical trial solutions offered by Fisher Clinical Services include:

• Biologistics Management
• Cell & Gene Therapy
• Clinical Ancillary Management
• Clinical Label Services
• Clinical Trial Packaging & Storage
• Clinical Supply Optimization Services
• Cold Chain Management & Expertise
• Direct-to-Patient
• Distribution & Logistics
• Strategic Comparator Sourcing
• Public Health Research

Established in 1997 under the name Kiecana Clinical Research, KCR is a full-service contract research organization that provides a variety of services for clinical monitoring, safety & pharmacovigilance, clinical project management, quality assurance and regulatory affairs.

KCR operates globally, and has offices in North America, Western Europe, Central Europe and Eartern Europe. The company currently employs more than 700 staff.

Some clinical trial solutions offered by KCR include:

• Trial Execution

10. Medpace

Founded in 1992 and based in Cincinnati, Ohio, Medpace is a midsize clinical contract research organization. The company has operations in over 45 countries, and employs over 2,800 people. Medpace provides support services for Phase I-IV clinical trials for pharmaceutical and biotechnology companies, which include central laboratory services and regulatory services.

Some clinical trial solutions offered by Medpace include:

• Biostatistics and Data Sciences
• Clinical Trial Management
• Drug Safety and Pharmacovigilance
• Medical Writing
• Quality Assurance
• Regulatory Affairs
• Risk-Based Monitoring
• Medpace Laboratories

11. Clintec

Now in business for over 22 years, Clintec is a medium-sized global contract research organization for pharmaceutical, biotech and medical device industries, with large expertise in oncology and rare diseases.

The company provides the flexibility and agility of a smaller-sized CRO, while also having a wide global coverage that large CRO companies are known for. Clintec is based in more than 50 countries, and was acquired by the leading global CRO IQVIA in late 2018.

Some clinical trial solutions offered by Clintec include:

• Project Management
• Data Management
• Biostatistics
• Global Feasibilities
• Patient Recruitment & Retention

12. Worldwide Clinical Trials

Bringing over 30 years of experience to the clinical research market, Worldwide Clinical Trials is a leading medium-sized global contract research organization. Founded by physicians with a dedication and commitment to advancing medical research, Worldwide Clinical Trials was the first customer-centric CRO.

Currently the company has coverage in more than 60 countries, and has extensive experience in a wide range of therapeutic areas, including central nervous system, metabolic, cardiovascular, oncology, rare diseases and general medicine.

Some clinical trial solutions offered by Worldwide Clinical Trials include:

• Bioanalytical Lab
• Early Phase Development
• Clinical Phase IIB-II Clinical Trials
• Phase IIIB-IV Clinical Trials
• Trial Management Technologies

Named #1 CRO in the world for operational excellence at the 2021 CRO Leadership Awards, CTI Clinical Trial And Consulting Services is a medium-sized global contract research organization that has been serving pharmaceutical companies since 1999.

Based in Covington, Kentucky, CTI has offices around the world in more than 60 countries, with coverage in North America, Europe, Latin America, Middle-East, Africa, and Asia-Pacific regions.

Some clinical trial solutions offered by CTI include:

• Feasibility
• Regulatory Affairs Study Start-Up
• Medical Monitoring
• Safety & Pharmacovigilance
• Clinical Services

14. Wuxi AppTec

Founded in 2000 as WuXi PharmaTech in the city of Wuxi, China, Wuxi AppTec has grown from a single laboratory into a leading global contract research organization with more than 28,000 employees, including 23,000 scientists and more than 30 research & development and manufacturing sites around the world.

With offices in Asia, U.S, Europe and the Middle East, the company is able to provide coverage to more than 30 countries around the world.

Some clinical trial solutions offered by Wuxi AppTec include:

• Small Molecule Drug R&D and Manufacturing
• Cell Therapy and Gene Therapy
• Drug R&D and Medical Device Testing
• Clinical Services (Phase I-IV)

15. Advanced Clinical

Founded in 1994 and based out of Deerfield, Illinois, Advanced Clinical is a midsize and full-service CRO that helps sponsors with running clinical trials. The company employs more than 700 staff, and offers a wide variety of services across many therapeutic areas. Advanced Clinical has global representation in over 50 countries around the world.

Some clinical trial solutions offered by Advanced Clinical include:

• eTMF & Document Management
• Global Medical Services
• Quality & Validation

16. Pharm-Olam

Pharm-Olam is a leading midsize CRO with global headquarters located in Houston, Texas and its European headquarters in Bracknell, United Kingdom. The company employs more than 800 staff, and has 25 offices around the world, with a global coverage in more than 60 countries.

The company has therapeutic expertise in 5 areas, including Rare & Orphan Disease, Infectious Disease & Vaccine, Oncology-Hematology, Allergy and Autoimmune.

Some clinical trial solutions offered by Pharm-Olam include:

• Study Feasibility
• Site Activation
• Patient Recruitment
• Medical Affairs
• Compliance & Training
• Clinical Monitoring & Operations

17. Clinipace

Founded in 2003 and based out of Morrisville, North Carolina, Clinipace is a global midsize full-service CRO with a focus on solution customization for clinical trials. The company has a large global coverage in more than 50 countries, and has offices in North America, South America, Europe and Asia-Pacific regions.

Clinipace’s therapeutic focus areas include Oncology, Nephrology and Urology, Rare Disease, Gastroenterology and Women’s Health. The company also has complete therapeutic expertise in Infectious Disease & Vaccines, Cardiology, CNS, Immunology, and Respiratory.

Some clinical trial solutions offered by Clinipace include:

• Clinical Analytics
• Clinical Technology and Ecosystem
• Functional Service Partnership (FSP)
• Regulatory & Strategic Product Development

9 Fundamental Questions To Ask A Top CRO Company Before Signing The Contract

1. which services does the cro provide.

CROs offload a lot of operational tasks from trial sponsors, which can touch any component of clinical trial operations. From formulating an overall study strategy and implementing technologies to support the operational processes of the trial, to picking and identifying sites, and supporting patients during the trial, the range of clinical services offered by a CRO tends to be vast and inclusive of all the typical services and support you will require for running a successful clinical trial.

However, not all CROs are the same in their service offerings, or are able to offer the same depth of capability within a seemingly same clinical trial support process. For this reason it is important to understand exactly which kind of clinical services and support you are looking to receive from the prospective CRO when running your clinical trial.

While services such as clinical monitoring and clinical trial management are offered by the majority of CROs, the specific needs of each trial are unique, and for this reason it is important to first identify what will be the unique services your trial requires. Completing this internal analysis first will help you to understand the extent to which a potential CRO partner will be able to provide all of these services.

Some CROs specialize in specific clinical trial functions which the company may label as a “core services”, in which case this is a sign the company will have more expertise, experience, and will be set up in a way to maximize their capabilities in providing support for these services compared to other services that the CRO offers.

For example, a CRO may include patient recruitment as part of its “core services”, which implies that they are highly skilled in and have the necessary infrastructure to design and implement a high-quality patient recruitment strategy.

Clara Health CRO Support Services: At Clara Health our specialty services include technology-augmented digital and patient advocacy recruitment, as well as patient support via our signature patient recruitment platform, which we use to upgrade clinical trials and deliver results sponsors look for in their recruitment and retention campaigns.

At Clara, we work alongside CROs to supplement and support clinical trials with modern and personalized capabilities that CROs do not typically have the bandwidth, corporate structure or infrastructure to support.

If you would like to learn more about exactly how our platform can upgrade your unique trial, feel free to book a Free 30 Minute Consultation Session Here with one of our in-house experts.

2. What Related Experience Does The CRO Have?

It is helpful to ask the prospective CRO company if they have any relevant experience in running clinical trials that would be an asset in designing and running your study. Previous experience in a related therapeutic area or in running a trial with a similar design allows CROs to have a deeper understanding into potential opportunities and challenges, increasing the likelihood of your clinical study being successful.

For example, if a sponsor is planning to run a trial in oncology, for the purpose of site identification and selection it would be valuable to partner with a CRO vendor that has expertise in this area, as they likely already have a good understanding of which sites will lead to optimal results.

However, it is also important to consider all factors when selecting a CRO vendor and not to rely on therapeutic experience as the sole qualifier for whether or not a potential CRO is a fit for your trial. While previous experience is beneficial, some sponsors close themselves off from working with vendors that have not worked in their therapeutic area, which significantly limits options when choosing a CRO partner that is truly a good fit for their clinical study.

This can impact the end result of your clinical study, as sponsors that are not successful in choosing a CRO vendor that is the right overall fit may face difficulties if the needs of their clinical study aren’t being properly met.

Clara Health: We have worked to provide support for clinical trials across a wide range of therapeutic areas and trial designs. Our specialty is filling in the gaps that CROs traditionally did not have to think about, which include digital patient recruitment, patient advocacy recruitment, and technology-augmented patient support.

Additionally, we are constantly building our proprietary data and running tests in a variety of therapeutic areas. These research efforts allow us to have a detailed understanding of the expected level of difficulty when recruiting particular patient populations, as well as allow us to predict with accuracy which segments of the targeted population will be likely to qualify in a particular study.

3. What Are The Communication Workflows & Expectations For Performing And Delivering Contracted Services?

It is important that you clarify what the expectations for communication will be between your prospective CRO vendor and your internal teams, as you will most likely be working with the CRO of your choice for the entire duration of your clinical trial.

There are a vast variety of factors and success determinants for a clinical trial, which are continuously undergoing change as the study unfolds. For this reason, it is recommended that you work with a CRO that is proactive in their communication, so that you are kept up to date with information about important changes as your clinical trial progresses.

A vendor that is proactive rather than reactive in their communication and approach to dealing with arising issues is one of the most important qualities in CRO. Challenging situations will naturally arise, and the promptness with which they are taken care of will significantly impact your clinical trial’s degree of success. Therefore, seeking a vendor that is able to match the standard of communication that you as a sponsor would like to experience throughout the duration of your partnership is one of the most critical steps in determining which CRO is the right fit for your clinical trial.

We’ve included a few additional questions pertaining to the communication structure and reporting expectations that you can ask a prospective CRO vendor to determine the degree of fit in this particular category:

Communication Expectations:

• If we were to move forward with you, which of your team members will be our main point of contact?
• How available will you be outside of the scheduled meetings to address any of our concerns or additional requests?
• What will be the frequency at which update meetings will be conducted, and who will be present at those meetings?
• Which clinical study processes will be reported on, and what will be the workflow for how we will receive this information?
• What will be the cadence at which we will receive progress reports?
• Would we be able to access metrics electronically via an interactive dashboard, or will you send us formal reports?

Clara Health: At Clara Health, we directly interact and actively work with several key stakeholders involved in running a clinical trial, which includes sponsors, CROs, sites, and patients. This unique position allows us to have a centralized perspective which helps us to see all the moving parts of a clinical trial at the same time, which helps to identify issues and relay this vital information and insight back to the sponsor (or other appropriate stakeholders) in the shortest time possible.

The ability to access this perspective allows us to gather the most accurate, complete, and up-to-date information about how the clinical trial is unfolding, and quickly becomes very valuable to sponsors for their clinical trial.

As an example, we may receive feedback from patients about having an unsatisfactory experience with a particular study site. We are able to aggregate and analyze this information, and relay our findings back to the sponsor and the study site to improve the experience for other patients.

4. What Is The CRO’s Client Satisfaction Record?

It is a good practice to request information or metrics from the prospective CRO vendor that can point to the degree of satisfaction of their past clients. Prior to signing the contract, vendors will naturally do their best to uplift their image and future value to you during their sales conversations with you and your team. It can be tricky to get an objective understanding of what the partnership experience will actually entail, especially when there are multiple vendors fighting for your commitment.

We recommend that you ask the prospective vendor to provide success metrics regarding areas of clinical trial operations that are going to be important for your trial.

For example, you may be interested in learning about the vendor’s relationship to finances, in which case it will be useful to ask them about situations in which they went over the planned budget, and investigate into the reasons behind that. Alternatively you may be concerned about potential delays in timelines, in which case it would be helpful to learn about metrics regarding the CRO’s ability to meet timeline expectations.

You may also request to talk to the prospective CRO’s past clients, which will help you to gain insight into what the relationship was like and give you the opportunity to examine if the way in which the particular CRO manages its relationships and performs its services meets the expectations that you would have for your potential relationship and for your clinical trial.

Clara Health: At Clara Health, our relationships with our partners and with our patients are most important to us. In the unique position where we fit in the clinical trial process, we have the opportunity to directly co-create the clinical trial patient experience with a variety of stakeholders, including sponsors, sites, CROs, and patients.

Our company’s values and culture have been directed and developed to be such that the client and patient experience is at the top of priority for all of our internal teams, and we work to provide the best quality of care to all stakeholders.

We have many testimonials from every type of partner we’ve worked with which we can happily share with you.

5. How Do You Adapt When Encountering Challenges With Running A Clinical Trial?

It is inevitable that challenges and unforeseen changes will arise throughout the operational clinical trial process, and for this reason it is important to work with a CRO vendor that can provide you with evidence of their flexibility and ability to adapt to sudden changes.

The ideal CRO partner is one that is highly consultative throughout the entire process, and has an ability and the initiative to deal with challenges at their seed stage, prior to them turning into major obstacles for the success of your trial.

CROs naturally have a large reach, and there are a lot of different clinical trial mechanisms and processes that are under their control. They are able to monitor and respond to what is going on in every key link in the chain of the clinical trial operation.

It is reasonable to expect this level of oversight from a CRO, and additional questions that can help you gain insight into this include:

• What are some examples where the CRO was effective at monitoring the health of clinical trials they’ve helped operate in the past?
• How quickly does the CRO respond to challenges or opportunities for improving the clinical trial experience?
• How well does the CRO gather & process information from study sites, study teams, patients & the sponsor, and what are their typical data analysis workflows?

It is also recommended to speak to the prospective CROs past clients to help you gain insight into how well they respond and adapt to the naturally arising challenges in clinical trials.

Clara Health: While CROs do have a large reach within the clinical trial, no CRO has complete visibility into every clinical process. They are not typically set up to support full visibility, which can manifest as a potential threat to your clinical trial as it unfolds. This is especially true for parts of the clinical trial processes that CROs naturally do not specialize and often subcontract, such as clinical trial recruitment.

At Clara, we are in a unique position in relation to other key partners involved in operating the clinical trial. We are in direct and frequent contact with patients, CROs, study sites, study teams, and the sponsor, and have a very deep understanding of the patient pipeline. This allows us the unique ability to go very deep into specific parts of the recruitment chain and investigate what is working and what is not working.

In addition, Clara functions as a resource for all partners in the clinical trial. For example, we work directly with site teams to ensure that they have access to a 3rd party that they can relay their needs to and receive fast support in case there is anything they require that can improve the patient recruitment process.

6. Which Parts Of Operating The Clinical Trial Will You Be Outsourcing?

Since there are so many processes and mechanisms that go into operating a clinical trial, CROs will always outsource some parts of running and managing the study. While you can expect that the prospective CRO will subcontract some of the work, it is important to find out which exact parts the clinical study will be outsourced.

There are certain basic and key clinical processes (such as site selection) that CROs almost always help with, and if you find that these parts of your trial are going to be subcontracted to another company, it is recommended to find out why the CROs operations are set up this way and how this would impact the service you will receive.

Ultimately what matters to you as a partner and client is that the quality of service and care that you will receive will be up to standard, and meet what was promised and what you are expecting. While this trust is important after you have signed the contract, it is recommended that prior to entering into such a significant commitment that you have evidence and the conviction that the CRO of your choice is truly the right fit and will deliver the quality of service that was being discussed.

Since it is impossible to predict exactly what the quality of this relationship and services performed will actually be like in practice, it is recommended that you understand the details of what will be done for your trial and how. Investigating how the CRO outsources and subcontracts services for a clinical trial will help you to gain necessary insight that you would need to make the correct vendor selection decision.

Clara Health: At Clara, we maximize the effectiveness of the digital component across the entire digital & recruitment spectrum, which is added on top of the existing capabilities of the CROs and other vendors involved in operating your clinical trial. In addition, we offer services that augment the CROs efforts, which has the potential to significantly improve the patient experience, operations flows, recruitment and retention performance, which is so important in ensuring the success of a clinical trial.

For example, if a CRO wants to have a great site relationship, we are able to come in as a third party on behalf of the sponsor and CRO and act as a resource and additional support for sites.

In another example, If a sponsor wants to have great relationships with the patient community, Clara is able to come in on behalf of the sponsor and develop these relationships while being perceived more neutrally by the patient community.

7. Do You Have Experience Running International Trials?

If you are planning on operating an international clinical trial, it is recommended to work with a CRO that has extensive experience in this area. While many CROs will offer near-global coverage, the level of experience with specific geographic locations can significantly vary from one vendor to another.

It is important to work with a CRO that has experience running clinical trials in the specific countries and regions you are planning to conduct your research in. Being compliant with the local rules and regulations for clinical testing is a very complex process that requires existing understanding and familiarity in order to ensure logistical smoothness and to mitigate legal risks. In operating a clinical trial, there are a multitude of clinical services and processes, which can greatly vary across the many regions in which you can conduct clinical testing.

A CRO that is lacking experience in operating international trials or operating in particular regions where you plan on conducting research may not be able to meet your desired quality and agility expectations, and therefore may not be the right fit for your international clinical trial.

Clara Health: In the past, we have provided international patient recruitment and digitally-augmented trial support services for clinical trials in the EU, Canada, UK, Australia and South America.

Clara Health is fully compliant to operate international studies everywhere in the world, with the exception of Russia and China.

8. What Is Your Relationship With Patients?

Patient-centric approach to designing and operating a clinical trial is becoming more and more crucial in the clinical research space. The ability of a sponsor and their CRO partner to understand the needs and characteristics of their target patient community is a significant determinant of whether or not the study will be a success.

A sponsor that has close and authentic relationships with the patient community tends to have a deeper understanding of how to create the best clinical trial experience that will attract patients and keep their interest throughout the clinical trial.

In addition, strong relationships with patients allow sponsors and CROs to forecast recruitment and patient retention pipeline with much higher accuracy. This ability is critical for ensuring the success of the trial and mitigating the risk of low enrollment. After an understanding of the patient population is acquired, sponsors gain the necessary insight to design a clinical trial that is not only favorable to their research results, but is also practical and will result in the enrollment numbers they are looking for.

While many CROs have already recognized the importance of patient-centricity and evolved the ways in which they design and operate clinical trials, other CROs have not yet made such a pivot in their values. It is important to understand the degree of importance the prospective CRO places on creating a favorable patient experience, and what kind of infrastructure the company has to support it.

At Clara, we recommend choosing a CRO partner that is adapting to the patient-centric model which is becoming more and more important for running a successful clinical trial.

Clara Health: Since early stages of our development, we’ve had a dedicated patient advocacy team that has been integral in shaping our company’s vision and operations. We have built our entire platform and recruitment infrastructure around creating the best experience for patients. Our teams, corporate values, service offerings and company infrastructure all work in the service of the patient.

In addition, over the many years of being in business we have heavily invested in building authentic patient community relationships that span across a variety of therapeutic areas. This has given us a unique ability to receive feedback directly from patients that is genuine and authentic around marketing materials, strategy for patient recruitment, and other services that we build for specific trials.

This ability to build partnerships with the patient community in an authentic way gives us a very unique ability to engage with the patient community on behalf of a pharmaceutical company, allowing our sponsor & CRO partners the opportunity to start conversations with patients through our in-house patient advocacy team.

If you would like to learn how Clara can help you to build a strong & authentic relationship with your target patient community, get in touch with us and we’d be happy to share our capabilities and previous results with you as they relate to your current or upcoming clinical trial.

9. How Is The CRO Going To Utilize Patient Input For Developing The Trial?

In the initial stages of clinical trial design, sponsors often determine the ideal patient profiles that would help them to drive the most favorable research outcomes for their study. While it is important for the success of your trial to determine who your ideal patients are, very often these projections do not match up with what is viable in practice.

At Clara, we often encounter study protocols that are not set up realistically for successful recruitment to be possible.

Common mistakes that are made when determining trial eligibility criteria and trial design include:

• Overestimating the interest in the clinical trial from the target patient population
• A lack of patient focus in the trial design
• A lack of convenience for patients in their participation
• Complicated and/or inefficient study experience flows
• Crafting the eligibility criteria around the patient population that is most likely to lead to favorable study outcomes, without conducting sufficient research to more accurately estimate the recruitment and retention difficulty of the group for a particular study

It is natural for there to be a “push & pull” between the research ideal and the real world practicality. It is important to determine the correct balance between these two sides for your trial, as going too far in either direction will decrease the chance of your clinical study’s success.

The nature of the industry as it is right now is such that there is excess research idealization and not enough emphasis on patient centricity. This distorted orientation has resulted in many clinical trials being unsuccessful, negatively impacting sponsors, patients and the entire clinical trials industry.

The ideal CRO partner should help you make sure that your protocol design sets your study up for success. The CRO should be able to help you determine the proper balance between the research ideal and the real world practicality, and back up their findings with sufficient research and patient data that can project your trial being a success.

Clara Health: When formulating a recruitment and retention plan for our clients, we begin with conducting thorough research into the target trial patient population. This allows us to get a clear understanding of which recruitment channels will yield the best results and what kind of marketing materials will resonate with the prospective study participants.

To ensure accuracy and real-world applicability of our research, we consult and collaborate with our internal patient advocacy and patient support teams, as well as with our clients and patients representing the target trial patient profiles. We then tie our findings back with any existing proprietary data that we have in connection with the therapeutic area or the prospective target patient group.

Our unique position within the clinical recruitment chain gives us the presence and deep-rooted access needed to effectively tap into any of the three patient traffic sources: digital recruitment, offline recruitment, or patient advocacy recruitment.

Once a recruitment campaign has gone live, we constantly monitor, analyze and optimize our performance to make sure that the processes we have in place are as efficient as possible and drive the greatest results. In addition, we have the capability to layer in any traditional advertising (such as billboard ads) if requested by the study sponsor.

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Top 15 Clinical Research Companies: Leaders in Medical Innovation

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In the healthcare industry, the number of contract research organizations in the US has reached 2,823 in 2023. This marks a subtle but significant increase of 0.9% compared to the previous year.

This increase signals a vital trend: the growing complexity of finding the best clinical research companies in a crowded field. These organizations aren’t just businesses; they’re important in advancing medicine and developing drugs and therapies.

With such an important task, choosing the right company becomes essential. In this guide, we’ve looked closely at many companies along with their strengths and weaknesses and made a list of the top clinical research organizations. 

By the end, you’ll know which company is the best fit for your needs.

Quick List of Top 15 Clinical Research Companies

Here is a quick overview of the best companies of clinical research:

• IQVIA: Best for data-driven insights and advanced analytics in healthcare research.
• ICON: Best for comprehensive clinical development services and therapeutic expertise.
• Parexel: Best for global biopharmaceutical services, emphasizing regulatory and clinical trial excellence.
• Syneos Health: Best for integrated biopharmaceutical solutions and clinical-commercial capabilities.
• PPD: Best for drug development services with innovative, technology-enhanced trial strategies.
• Labcorp: Best for comprehensive clinical testing and diagnostics services with global reach.
• Medpace: Best for expertise in clinical research and regulatory affairs for pharmaceutical companies.
• Charles River Laboratories: Best for preclinical research and development services, including animal testing and research models.
• PRA Health Sciences: Best for clinical trial expertise and integrated solutions for biopharmaceutical development.
• AdvanCell: Best for innovative cell and tissue-based research solutions for life science industries.
• Dynata: Best for data-driven insights and market research services for informed decision-making.
• Covance: Best for end-to-end drug development solutions, from preclinical to post-marketing.
• MedNet: Best for technology solutions and eClinical platforms for streamlined clinical trials.
• Fisher Clinical Services Inc: Best for global logistics and supply chain services for clinical trial materials.
• Worldwide Clinical Trials: Best for specialized CRO offering personalized clinical research solutions.

3 Best Clinical Research Organizations: Comparison Chart

Here’s a comparison table to highlight the key features and differences among the best companies of clinical research. This table aims to provide a quick overview of each company’s unique strengths and areas of expertise in the pharmaceutical and healthcare research sector.

3 Top Clinical Research Organization List For Advanced Medical Discoveries

Now, we’ll explore the top clinical research organizations (CROs) dedicated to advancing medical discoveries. Let’s jump into the details of these exceptional organizations.

IQVIA is a global leader in clinical research and healthcare data analytics. They play a crucial role in the medical field by providing comprehensive data, advanced analytics, and expert insights. This helps pharmaceutical and healthcare companies make smarter, more effective decisions. 

Why is IQVIA among the best? Their strength lies in their vast database and advanced technology, which enable them to analyze complex healthcare data efficiently. This leads to a better understanding of diseases, more effective treatments, and faster drug development. 

IQVIA’s work is essential because it speeds up the process of bringing new medicines to the market, ultimately benefiting patients worldwide. In short, IQVIA is a key catalyst in advancing global healthcare.

About IQVIA

• Founding Team: Dennis Gillings
• Founding Year: 1982
• Company Size:   86,000

Features of IQVIA

IQVIA, a prominent player in the life sciences sector, is dedicated to advancing healthcare through connected intelligence. Here are some key features of IQVIA in the world of clinical research:

Innovative Clinical Development

IQVIA is reimagining clinical development by intelligently connecting data, technology, and analytics. This approach leads to faster decision-making and reduced risk, enabling the delivery of life-changing therapies more quickly.

Efficient Payment Systems for Clinical Trials 

They have simplified the process of paying sites involved in clinical trials. IQVIA offers the capability to make payments within 30 days, even in challenging locations. This significantly reduces the administrative burden of managing clinical trial payments by up to 90%.

Decentralized Trials Expertise

The company has conducted over 500 studies in more than 75 countries, covering over 30 indications using decentralized trial methodologies. This demonstrates their capability in managing complex, multinational clinical trials.

Global Reach and Impact

With a presence in various regions, including Australia, New Zealand, the Middle East, and Africa, IQVIA’s global footprint allows it to drive healthcare innovations worldwide.

AI and Technology Integration

The company is at the forefront of integrating AI and other technologies in healthcare. Their Healthcare-grade AI promises precision, speed, scale, trust, and reliability, essential for advancing health and improving patient outcomes.

• Extensive, reliable healthcare data enhances market research quality.
• Utilizes AI and machine learning for advanced healthcare insights.
• Specialized focus yields a deep understanding of healthcare dynamics.
• Broad international presence enables diverse and large-scale studies.
• Offers advanced tools for insightful healthcare data analysis.
• Advanced tools can be challenging to use without training.
• Handling sensitive health data raises privacy and security issues.

Our Review of IQVIA

IQVIA, a prominent player in the healthcare and life sciences industry, presents a mixed bag of strengths and weaknesses. On the positive side, we appreciate IQVIA’s extensive expertise in data analytics and healthcare consulting. 

Their comprehensive research and analysis have undoubtedly driven valuable insights and innovations in the sector. Moreover, their global presence allows for diverse perspectives and access to critical healthcare data.

However, we must also acknowledge some shortcomings. IQVIA’s services can be prohibitively expensive for smaller organizations, limiting accessibility. Additionally, the sheer volume of data can sometimes lead to information overload, making it challenging to extract actionable insights.

ICON is a prominent company in the field of clinical research, playing a significant role in advancing medical science. They specialize in designing and conducting clinical trials for new medicines and treatments. 

The work of ICON is crucial because they help determine the safety and effectiveness of these potential medical breakthroughs. They are considered one of the best in clinical research due to their high standards of accuracy, reliability, and ethical practices. 

ICON’s expertise ensures that the clinical trials they manage are conducted efficiently and effectively, leading to faster approval of new treatments. This directly impacts patient care, as it allows quicker access to new, potentially life-saving medicines. 

In essence, ICON’s contribution is vital in driving forward medical innovations.

• Founding Team: John Climax and Ronan Lambe
• Founding Year: 1990
• Company Size: 41,160

Features of ICON

Here are some of the key features of ICON in clinical research:

Diverse Clinical and Scientific Operations

ICON offers a wide range of clinical and scientific operations services, ensuring comprehensive support for various aspects of clinical trials. This includes everything from study design to execution and data analysis.

Decentralized Clinical Trial Solutions

They provide end-to-end services, operational models, and technology to deliver customized solutions for decentralized clinical trials. This approach is increasingly important in today’s clinical research landscape, offering flexibility and efficiency.

Specialized Therapeutic Areas

ICON has expertise across multiple therapeutic areas including cardiovascular, central nervous system, endocrine & metabolic disorders, infectious diseases, internal medicine & immunology, oncology, and more. This broad expertise allows them to handle a wide range of clinical research projects.

Innovative Solutions for Biotech

ICON provides full-service outsourcing and flexible support customized to the specific needs of biotech companies. This includes due diligence and asset valuation, which are critical for biotech firms navigating the complex landscape of drug development.

Advanced Medical Imaging Solutions

Their expert medical imaging solutions support all stages of clinical research, improving decision-making, increasing efficiency, and reducing trial costs.

• Decades of expertise ensure high-quality clinical research.
• Offers wide-reaching capabilities for multi-regional clinical studies.
• Deep understanding of global regulations enhances compliance and efficiency.
• Invests in new technologies for more efficient trial processes.
• Broad range of specialties contributes to comprehensive service offerings.
• Managing multi-regional trials can lead to logistical challenges.
• Rapid growth may strain resources and affect service quality.

Our Review of ICON

When we researched ICON, we found both commendable aspects and areas for improvement. On the positive side, we appreciate their commitment to clinical research and their global presence, which allows for diverse study options. Their experienced team and advanced technology contribute to reliable data collection and analysis.

However, there are some drawbacks to consider. We have noticed occasional delays in project timelines, which can be frustrating. Additionally, the cost of their services tends to be on the higher side, making it a potential barrier for smaller research endeavors.

Parexel is a globally recognized company in clinical research, known for its important role in developing new medical treatments. They are one of the biggest clinical research organizations. Parexel conducts clinical trials, crucial steps in testing the safety and effectiveness of new drugs. 

The work of Parexel is essential because it bridges the gap between medical research and the availability of new treatments to patients. One of the reasons they stand out as one of the best in this field is their rigorous approach to research. 

Their commitment to quality and their global network also enables diverse and large-scale studies, setting them apart from others in the field. These strengths allow Parexel to deliver reliable and valuable data, accelerating the process of bringing new, effective medicines to the market. 

Simply put, Parexel is a key player in transforming medical research into real-world health solutions.

About Parexel

• Founding Team: Josef von Rickenbach and Anne B. Sayigh
• Company Size: 18,900

Features of Parexel

Parexel, a global biopharmaceutical services organization, offers a range of features in clinical research. Here are some key aspects of their approach:

Patient-Centric Approach

Parexel emphasizes a patient-first strategy in their clinical trials. This approach results in deeper and more relevant insights for trial design and execution. This ensures that the trials are more aligned with patient needs and experiences.

Innovative Trial Designs

Parexel employs innovative trial designs to optimize trials for maximum impact. This includes advanced modeling and simulation to predict drug effects ahead of time, which can save time, money, and resources.

Regulatory Compliance and Market Access

Parexel designs studies and endpoints with market access in mind, ensuring that they satisfy global regulations. This approach helps in getting treatments to patients safely and quickly.

Patient Advocacy and Engagement

The company includes patient advocates in their council, using their experiences to improve trial designs. This inclusion demonstrates their commitment to understanding and incorporating patient perspectives in clinical research.

Focus on Speed and Precision

Parexel aims to design neuroscience trials with speed and precision, utilizing the right experts and specializations. This focus is crucial in delivering effective treatments on time.

• Provides advanced technology and analytics for efficient data management.
• Extensive network provides global insights with regional knowledge.
• Expertise in navigating complex regulatory environments worldwide.
• Broad experience across various therapeutic areas ensures versatile solutions.
• Focuses on patient engagement for more effective trial outcomes.
• Rapid expansion can lead to challenges in resource management.
• Concentration in specific areas could pose risks in market shifts.

Our Review of Parexel

Parexel is a notable player in the field of clinical research and pharmaceutical services. We’ve thoroughly analyzed their offerings and found both strengths and areas that need improvement.

On the positive side, Parexel excels in its commitment to innovation and technology. We appreciate their continuous efforts to simplify clinical trials and drug development processes, making them more efficient.

However, we also noticed some downsides. Communication with clients could be more transparent, with clearer updates on project progress. Additionally, there’s room for improvement in terms of ensuring consistency in service quality across different projects.

Other 12 Companies of Clinical Research

In the world of clinical research, beyond the well-known names, there are 12 other companies making significant contributions. Let’s explore their vital role in advancing healthcare.

1. Syneos Health

Syneos Health helps develop medicines by managing clinical trials for new drugs. They’re essential because they ensure medicines are safe and effective. Syneos Health stands out in clinical research for its comprehensive services and global reach, making drug development smoother and faster.

About Syneos Health

• Founding Team: Colin Shannon
• Founding Year: 1980
• Company Size: 28,000

PPD is a group that tests new drugs to see if they’re good and safe. This is crucial for getting new treatments to people. They stand out for their thorough research and global reach.

• Founding Team: Fred Eshelman 
• Founding Year: 1985
• Company Size: 40,000+3

Labcorp does important tests and research for health. They’re needed because they help find out if new treatments are good. They’re among the best for their big labs and fast results.

About Labcorp

• Founding Team: Matthew Benger
• Founding Year: 1978
• Company Size: 75,5000

Medpace focuses on making sure new health treatments are safe. This is key for better medicine. They’re a top choice because of their focus on quality and detail in research.

About Medpace

• Founding Team: August Troendle
• Founding Year: 1992
• Company Size: 5,400

5. Charles River Laboratories

Charles River Laboratories tests drugs and does research to help pets and people stay healthy. They’re essential for safe, new treatments. Their expertise makes them a leader in the field.

About Charles River Laboratories

• Founding Team: Henry Foster
• Founding Year: 1947
• Company Size: 21,400

6. PRA Health Science

PRA Health Science works on finding out if new medicines are safe. This helps everyone get better treatments. They’re known for their excellent research and care in studies.

About PRA Health Science

• Founding Year: 1976
• Company Size: 17,000+

7. AdvanCell

AdvanCell specializes in new treatments, checking if they’re safe and working. Their work is vital for progress in medicine. They’re recognized for their innovation in research.

About AdvanCell

• Founding Team: Andrew Adamovich

Dynata gathers data for health studies. They’re needed for understanding what works in healthcare. They’re a top name for their accurate and wide-reaching data collection.

About Dynata

• Founding Team: Mike Petrullo
• Founding Year: 1940
• Company Size: 5000-10000

Covance helps with drug tests and research to fight diseases. Their role is key for new treatments. They’re celebrated for their comprehensive services and global impact.

About Covance

• Founding Team: Fred Cummings
• Founding Year: 1981
• Company Size: 50,000

MedNet provides software for managing clinical trials. This helps in making research easier and faster. They’re among the best for their tech solutions in research.

About MedNet

• Founding Team: John “Rob” Robertson
• Founding Year: 1996
• Company Size: 51-200

11. Fisher Clinical Services Inc.

Fisher Clinical Services Inc. manages the logistics of clinical trials, ensuring that treatments are tested efficiently. Their work is crucial for the progress of medicine, and they are renowned for their reliability and global network.

About Fisher Clinical Services Inc.

• Founding Team: John Pickering
• Founding Year: 1989

12. Worldwide Clinical Trials

Worldwide Clinical Trials conducts essential research to evaluate new medical treatments. Their work is critical for advancing healthcare. They are distinguished by their global expertise and commitment to innovation in clinical research.

About Worldwide Clinical Trials

• Founding Team: Neal Cutler
• Founding Year: 1986
• Company Size: 3,147

What To Consider When Choosing the Best Clinical Research Companies?

Choosing the right clinical research company (CRC) is crucial for the success of any clinical trial. Here’s a detailed guide on what to consider:

Expertise and Specialization

Always ensure the CRC has expertise in your specific therapeutic area. Companies with experience in similar drug trials or medical devices can better navigate the complexities of your project.

Regulatory Compliance

The CRC must adhere to regulatory guidelines like FDA (US) , EMA (Europe), and others. Check their track record in meeting these standards to avoid compliance issues.

Reputation and Track Record

You should research the company’s history. Look for testimonials, case studies, and reviews from past clients. A company with a strong reputation is likely to deliver quality results.

Project Management Capabilities

Effective project management is key. Assess their ability to manage timelines, budgets, and communication. A CRC that provides transparent, regular updates is preferable.

Patient Recruitment Strategies

Patient recruitment can be challenging. Evaluate their strategies for participant recruitment and retention. Consider their demographic reach and methods for ensuring a diverse participant pool.

Data Management and Analysis

The CRC should have strong systems for data collection, management, and analysis. Ask about their use of Electronic Data Capture (EDC) systems and how they handle data security and confidentiality.

Cost and Financial Terms

Get a clear understanding of the cost structure. Consider the value for money rather than just the lowest cost. Ensure there are no hidden fees and clarify what is included in the quoted price.

How Heartbeat AI Can Help You Get the Best List of Clinical Research Organizations?

Heartbeat AI, with its advanced features, can significantly assist in identifying the best list of clinical research organizations (CROs). Here’s how its various features contribute to this process:

Data Analysis and Processing

Heartbeat AI excels in analyzing vast amounts of data. When it comes to selecting CROs, it can process and analyze information from numerous sources, including past performance records, clinical trial reports, and regulatory compliance data. This thorough analysis helps in identifying CROs with a proven track record of success and reliability.

Machine Learning Algorithms

These algorithms enable Heartbeat AI to learn from historical data and improve its recommendations over time. By understanding trends and patterns in the successful execution of clinical trials, it can better predict which CROs are likely to meet your specific needs.

Predictive Analytics

Heartbeat AI uses predictive models to forecast future trends and outcomes based on historical data. This can be invaluable in predicting the success rate of CROs in upcoming projects, thus aiding in making more informed choices.

Customization and Personalization

The AI can be customized to your specific requirements. If you’re focusing on a specific therapeutic area or clinical trial phase, Heartbeat AI can prioritize specialized CROs in these fields.

Real-time Data Updates

The healthcare and pharmaceutical landscapes are constantly changing. Heartbeat AI’s ability to integrate and analyze real-time data ensures that the recommendations are based on the most current information available.

Integration with External Databases

Heartbeat AI can integrate with various external databases and platforms. This enables it to pull in comprehensive information about CROs from diverse sources, enhancing the accuracy of its recommendations.

Claim $500 of Free Data  

Summing up, we’ve explored the best clinical research companies, diving into their features, strengths, weaknesses, and more. Clinical research is vital in healthcare; it’s key for advancing medical knowledge and developing new treatments. 

With this guide, you’re equipped to find the right clinical research company that meets your specific needs. Whether it’s for innovative therapies, drug development, or medical advancements, choosing the right partner is crucial. This guide serves as a valuable resource to help you make an informed decision in the complex world of clinical research.

Frequently Asked Question

What services do companies of clinical research offer.

Clinical research organizations offer a wide range of services, including protocol development, patient recruitment, data collection and analysis, regulatory compliance, and more.

What is the role of a clinical research coordinator?

A clinical research coordinator is responsible for managing various aspects of a clinical trial, including patient recruitment, data collection, and ensuring compliance with protocols.

What is informed consent in clinical research?

Informed consent is the process by which participants in a clinical trial are fully informed about the study’s purpose, risks, and benefits. They voluntarily agree to participate based on this information.

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From the RCR Blog

Bpoc launches atlas clinical research, a premier clinical research site platform.

Posted on April 13, 2023

Simultaneously forms strategic partnership with Rochester Clinical Research, marking the foundational clinical research site of the new platform CHICAGO, April 12, 2023 /PRNewswire/ — BPOC, a pure-play healthcare investor with over 25 years of experience in middle market private equity, today announced the launch of Atlas Clinical Research (“Atlas”), a therapeutically-driven clinical site network built on centralized process […]

Rochester Clinical Research Announces New Site in Buffalo, New York

Posted on March 12, 2024

Rochester, NY – Rochester Clinical Research (RCR), an Atlas Clinical Research Site, is excited to announce the expansion of its clinical research network with a new site set to open in Buffalo, NY. The new site, RCR Buffalo, is set to commence operations in April of this year, marking a significant milestone in RCR’s mission […]

Rochester Clinical Research Partners with Rochester Hope to Uplift the Community

Posted on November 9, 2023

RCR announces partnership with a local non-profit called Rochester Hope [Rochester, New York] — Rochester Clinical Research (RCR) has announced its partnership with Rochester Hope, a non-profit organization dedicated to providing vital services and support to the local community. This collaboration represents a powerful commitment to making a positive impact on the lives of Rochester […]

A Shot at Double Protection: Join Our COVID & Flu Vaccine Trial!

Posted on October 10, 2023

In the ongoing battle against infectious diseases, one thing is for certain: a strong immune system is your best defense. Now, imagine a world where you can bolster your defenses against both COVID-19 and the flu with a single shot. Well, that world might be closer than you think. A Dual Defense Strategy As healthcare […]

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One of the first challenging problems is the need for earlier detection of infection, creating technology that can alert people when they have been infected with a bacteria or virus even before they begin to feel sick. The second is the urgent need to solve sepsis, the body’s life-threatening response to infection or traumatic injury. Sepsis is a top cause of hospitalization in America, leads to 250,000 deaths annually and costs approximately $24 billion a year to treat. The number of sepsis cases could skyrocket after a bioterrorism attack or pandemic.

A new HHS unit called DRIVe – part of the Biomedical Advanced Research and Development Authority ( BARDA ) at the HHS Office of the Assistant Secretary for Preparedness and Response – will oversee the accelerator network and is recruiting a nonprofit partner that can work with private investors to fund innovative technologies and products to solve these and other systemic health security challenges. DRIVe also can invest in the projects using quick, streamlined funding methods.

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SUNY Research Foundation received a $100,000 DRIVe grant to serve as an accelerator. Other accelerators are: First Flight Venture Center (Research Triangle Park, NC), MedTech Innovator (Los Angeles), New Orleans BioInnovation Center, Texas Medical Center Innovation Institute (Houston), University City Science Center (Philadelphia), Massachusetts Medical Device Development Center (Lowell), and Life Science Washington Institute (Seattle).

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For more about ASPR and BARDA, visit www.phe.g​ov/aspr . To connect with SUNY Research Foundation and partner with DRIVe, visit DRIVe.hhs.gov .

Cultural Relativity and Acceptance of Embryonic Stem Cell Research

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There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities.

INTRODUCTION

Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve.

Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes. [1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research. [2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.” [3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops. [4]  Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture.

I.     Global Cultural Perspective of Embryonic Stem Cells

Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense, [5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research. [6] Consequently, global engagement in ESC research depends on social-cultural acceptability.

a.     US and Rights-Based Cultures

In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism, [7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.” [8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed. [9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field. [10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture. [11]

b.     Ubuntu and Collective Cultures

African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama , which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,” [12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth. [13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole. Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value. [14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society.

Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.” [15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail.

Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable. [16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus. [17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines. [18]

Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim. [19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research. [20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF.  Their use is conditioned on consent, and available only to married couples. [21] The community's receptiveness to stem cell research depends on including communitarian African ethics.

c.     Asia

Some Asian countries also have a collective model of ethics and decision making. [22] In China, the ethics model promotes a sincere respect for life or human dignity, [23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM), [24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life. [25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research. [26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions. [27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency. [28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021. [29] However, issues still need to be addressed in implementing effective IRB review and approval procedures.

The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy, [30] research ethics should also adapt to ensure respect for the values of its represented peoples.

Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies. [31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells. [32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval, [33] and in another instance, the oocyte source was unclear and possibly violated ethical standards. [34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust.

d.     Middle East

Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells, [35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research. [36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors. [37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so. [38]

Jordan has a positive research ethics culture. [39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial. [40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation. [41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.” [42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes.

e.     Europe

In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected. [43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research. [44]

For example, in Germany, Lebenzusammenhang , or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.” [45]  Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount. [46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007. [47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization. [48] Spain’s approach differs still, with a comprehensive regulatory framework. [49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility. [50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices. [51]

II.     Religious Perspectives on ESC

Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives.

The Qur'an states:

“And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.” [52]

Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception. [53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible. [54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research. [55]

In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided. [56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden. [57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all. [58] Acceptance varies on applied beliefs and interpretations.

Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero, [59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all. [60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime. [61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit. [62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets. [63]

Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life. [64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception: [65]

“If she is found pregnant, until the fortieth day it is mere fluid,” [66]

Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation. [67] Stem cell research is accepted due to application of these religious laws.

We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory , which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions. [68] We only wish to show that the interaction with morality varies between cultures and countries.

III.     A Flexible Ethical Approach

The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities.

While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe. [69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation.

For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent. [70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context, [71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders.  This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research.

Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values. [72]

An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions. [73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion.

IV.     Concerns

Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values. [74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions.

Other concerns include medical tourism, which may promote health inequities. [75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments. [76]

For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.” [77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices. [78]

The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.” [79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds. [80]

While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research.

For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society.

This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model.

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[5] Concerning the moral philosophies of stem cell research, our paper does not posit a personal moral stance nor delve into the “when” of human life begins. To read further about the philosophical debate, consider the following sources:

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[7] Socially, at its core, the Western approach to ethics is widely principle-based, autonomy being one of the key factors to ensure a fundamental respect for persons within research. For information regarding autonomy in research, see: Department of Health, Education, and Welfare, & National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.; For a more in-depth review of autonomy within the US, see: Beauchamp, T. L., & Childress, J. F. (1994). Principles of Biomedical Ethics . Oxford University Press.

[8] Sherley v. Sebelius , 644 F.3d 388 (D.C. Cir. 2011), citing 45 C.F.R. 46.204(b) and [42 U.S.C. § 289g(b)]. https://www.cadc.uscourts.gov/internet/opinions.nsf/6c690438a9b43dd685257a64004ebf99/$file/11-5241-1391178.pdf

[9] Stem Cell Research Enhancement Act of 2005, H. R. 810, 109 th Cong. (2001). https://www.govtrack.us/congress/bills/109/hr810/text ; Bush, G. W. (2006, July 19). Message to the House of Representatives . National Archives and Records Administration. https://georgewbush-whitehouse.archives.gov/news/releases/2006/07/20060719-5.html

[10] National Archives and Records Administration. (2009, March 9). Executive order 13505 -- removing barriers to responsible scientific research involving human stem cells . National Archives and Records Administration. https://obamawhitehouse.archives.gov/the-press-office/removing-barriers-responsible-scientific-research-involving-human-stem-cells

[11] Hurlbut, W. B. (2006). Science, Religion, and the Politics of Stem Cells.  Social Research ,  73 (3), 819–834. http://www.jstor.org/stable/40971854

[12] Akpa-Inyang, Francis & Chima, Sylvester. (2021). South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study. BMC Medical Ethics . 22. 10.1186/s12910-021-00678-4.

[13] Source for further reading: Tangwa G. B. (2007). Moral status of embryonic stem cells: perspective of an African villager. Bioethics , 21(8), 449–457. https://doi.org/10.1111/j.1467-8519.2007.00582.x , see also Mnisi, F. M. (2020). An African analysis based on ethics of Ubuntu - are human embryonic stem cell patents morally justifiable? African Insight , 49 (4).

[14] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics , 22 (2), 112–122. https://doi.org/10.1111/dewb.12324

[15] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics, 22(2), 112–122. https://doi.org/10.1111/dewb.12324

[16] Jackson, C.S., Pepper, M.S. Opportunities and barriers to establishing a cell therapy programme in South Africa.  Stem Cell Res Ther   4 , 54 (2013). https://doi.org/10.1186/scrt204 ; Pew Research Center. (2014, May 1). Public health a major priority in African nations . Pew Research Center’s Global Attitudes Project. https://www.pewresearch.org/global/2014/05/01/public-health-a-major-priority-in-african-nations/

[17] Department of Health Republic of South Africa. (2021). Health Research Priorities (revised) for South Africa 2021-2024 . National Health Research Strategy. https://www.health.gov.za/wp-content/uploads/2022/05/National-Health-Research-Priorities-2021-2024.pdf

[18] Oosthuizen, H. (2013). Legal and Ethical Issues in Stem Cell Research in South Africa. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_80 , see also: Gaobotse G (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[19] United States Bureau of Citizenship and Immigration Services. (1998). Tunisia: Information on the status of Christian conversions in Tunisia . UNHCR Web Archive. https://webarchive.archive.unhcr.org/20230522142618/https://www.refworld.org/docid/3df0be9a2.html

[20] Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[21] Kooli, C. Review of assisted reproduction techniques, laws, and regulations in Muslim countries.  Middle East Fertil Soc J   24 , 8 (2020). https://doi.org/10.1186/s43043-019-0011-0 ; Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[22] Pang M. C. (1999). Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions. Journal of medical ethics , 25(3), 247–253. https://doi.org/10.1136/jme.25.3.247

[23] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[24] Wang, Y., Xue, Y., & Guo, H. D. (2022). Intervention effects of traditional Chinese medicine on stem cell therapy of myocardial infarction.  Frontiers in pharmacology ,  13 , 1013740. https://doi.org/10.3389/fphar.2022.1013740

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[28] Zhang, J. Y. (2017). Lost in translation? accountability and governance of Clinical Stem Cell Research in China. Regenerative Medicine , 12 (6), 647–656. https://doi.org/10.2217/rme-2017-0035

[29] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[30] Chen, H., Wei, T., Wang, H.  et al.  Association of China’s two-child policy with changes in number of births and birth defects rate, 2008–2017.  BMC Public Health   22 , 434 (2022). https://doi.org/10.1186/s12889-022-12839-0

[31] Azuma, K. Regulatory Landscape of Regenerative Medicine in Japan.  Curr Stem Cell Rep   1 , 118–128 (2015). https://doi.org/10.1007/s40778-015-0012-6

[32] Harris, R. (2005, May 19). Researchers Report Advance in Stem Cell Production . NPR. https://www.npr.org/2005/05/19/4658967/researchers-report-advance-in-stem-cell-production

[33] Park, S. (2012). South Korea steps up stem-cell work.  Nature . https://doi.org/10.1038/nature.2012.10565

[34] Resnik, D. B., Shamoo, A. E., & Krimsky, S. (2006). Fraudulent human embryonic stem cell research in South Korea: lessons learned.  Accountability in research ,  13 (1), 101–109. https://doi.org/10.1080/08989620600634193 .

[35] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

[36] Association for the Advancement of Blood and Biotherapies.  https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia

[37] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia.  BMC medical ethics ,  21 (1), 35. https://doi.org/10.1186/s12910-020-00482-6

[38] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics , 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics , 23 (3), 260–268. https://doi.org/10.1111/dewb.12355 ; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know . Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know

[39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[40] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[41] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[42] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France.  Biotechnology Law Report ,  32 (6), 349–356. https://doi.org/10.1089/blr.2013.9865

[45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[46] Tomuschat, C., Currie, D. P., Kommers, D. P., & Kerr, R. (Trans.). (1949, May 23). Basic law for the Federal Republic of Germany. https://www.btg-bestellservice.de/pdf/80201000.pdf

[47] Regulation of Stem Cell Research in Germany . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany

[48] Regulation of Stem Cell Research in Finland . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland

[49] Regulation of Stem Cell Research in Spain . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain

[50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered:

Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110.

Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ...  Revista do Colegio Brasileiro de Cirurgioes ,  41 (5), 374–377. https://doi.org/10.1590/0100-69912014005013

Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India . Routledge.

For further research on specific European countries regarding ethical and regulatory framework, we recommend this database: Regulation of Stem Cell Research in Europe . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-europe   

[51] Klitzman, R. (2006). Complications of culture in obtaining informed consent. The American Journal of Bioethics, 6(1), 20–21. https://doi.org/10.1080/15265160500394671 see also: Ekmekci, P. E., & Arda, B. (2017). Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.  Cultura (Iasi, Romania) ,  14 (2), 159–172.; For why trust is important in research, see also: Gray, B., Hilder, J., Macdonald, L., Tester, R., Dowell, A., & Stubbe, M. (2017). Are research ethics guidelines culturally competent?  Research Ethics ,  13 (1), 23-41.  https://doi.org/10.1177/1747016116650235

[52] The Qur'an  (M. Khattab, Trans.). (1965). Al-Mu’minun, 23: 12-14. https://quran.com/23

[53] Lenfest, Y. (2017, December 8). Islam and the beginning of human life . Bill of Health. https://blog.petrieflom.law.harvard.edu/2017/12/08/islam-and-the-beginning-of-human-life/

[54] Aksoy, S. (2005). Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research. Journal of Medical Ethics , 31: 399-403.; see also: Mahmoud, Azza. "Islamic Bioethics: National Regulations and Guidelines of Human Stem Cell Research in the Muslim World." Master's thesis, Chapman University, 2022. https://doi.org/10.36837/ chapman.000386

[55] Rashid, R. (2022). When does Ensoulment occur in the Human Foetus. Journal of the British Islamic Medical Association , 12 (4). ISSN 2634 8071. https://www.jbima.com/wp-content/uploads/2023/01/2-Ethics-3_-Ensoulment_Rafaqat.pdf.

[56] Sivaraman, M. & Noor, S. (2017). Ethics of embryonic stem cell research according to Buddhist, Hindu, Catholic, and Islamic religions: perspective from Malaysia. Asian Biomedicine,8(1) 43-52.  https://doi.org/10.5372/1905-7415.0801.260

[57] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[58] Lecso, P. A. (1991). The Bodhisattva Ideal and Organ Transplantation.  Journal of Religion and Health ,  30 (1), 35–41. http://www.jstor.org/stable/27510629 ; Bodhisattva, S. (n.d.). The Key of Becoming a Bodhisattva . A Guide to the Bodhisattva Way of Life. http://www.buddhism.org/Sutras/2/BodhisattvaWay.htm

[59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. (( King James Bible . (1999). Oxford University Press. (original work published 1769))

Jerimiah 1: 5 “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…”

In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David.

Psalm 139: 13-14 “…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…”

These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth.

[60] It should be noted that abortion is not supported as well.

[61] The Vatican. (1987, February 22). Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day . Congregation For the Doctrine of the Faith. https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html

[62] The Vatican. (2000, August 25). Declaration On the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells . Pontifical Academy for Life. https://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html ; Ohara, N. (2003). Ethical Consideration of Experimentation Using Living Human Embryos: The Catholic Church’s Position on Human Embryonic Stem Cell Research and Human Cloning. Department of Obstetrics and Gynecology . Retrieved from https://article.imrpress.com/journal/CEOG/30/2-3/pii/2003018/77-81.pdf.

[63] Smith, G. A. (2022, May 23). Like Americans overall, Catholics vary in their abortion views, with regular mass attenders most opposed . Pew Research Center. https://www.pewresearch.org/short-reads/2022/05/23/like-americans-overall-catholics-vary-in-their-abortion-views-with-regular-mass-attenders-most-opposed/

[64] Rosner, F., & Reichman, E. (2002). Embryonic stem cell research in Jewish law. Journal of halacha and contemporary society , (43), 49–68.; Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[65] Schenker J. G. (2008). The beginning of human life: status of embryo. Perspectives in Halakha (Jewish Religious Law).  Journal of assisted reproduction and genetics ,  25 (6), 271–276. https://doi.org/10.1007/s10815-008-9221-6

[66] Ruttenberg, D. (2020, May 5). The Torah of Abortion Justice (annotated source sheet) . Sefaria. https://www.sefaria.org/sheets/234926.7?lang=bi&with=all&lang2=en

[67] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[68] Gert, B. (2007). Common morality: Deciding what to do . Oxford Univ. Press.

[69] World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA , 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 Declaration of Helsinki – WMA – The World Medical Association .; see also: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979).  The Belmont report: Ethical principles and guidelines for the protection of human subjects of research . U.S. Department of Health and Human Services.  https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[70] Zakarin Safier, L., Gumer, A., Kline, M., Egli, D., & Sauer, M. V. (2018). Compensating human subjects providing oocytes for stem cell research: 9-year experience and outcomes.  Journal of assisted reproduction and genetics ,  35 (7), 1219–1225. https://doi.org/10.1007/s10815-018-1171-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063839/ see also: Riordan, N. H., & Paz Rodríguez, J. (2021). Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial. Stem Cells Translational Medicine , 10 (12), 1715–1716. https://doi.org/10.1002/sctm.21-0234

[71] Klitzman, R., & Sauer, M. V. (2009). Payment of egg donors in stem cell research in the USA.  Reproductive biomedicine online ,  18 (5), 603–608. https://doi.org/10.1016/s1472-6483(10)60002-8

[72] Krosin, M. T., Klitzman, R., Levin, B., Cheng, J., & Ranney, M. L. (2006). Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa.  Clinical trials (London, England) ,  3 (3), 306–313. https://doi.org/10.1191/1740774506cn150oa

[73] Veatch, Robert M.  Hippocratic, Religious, and Secular Medical Ethics: The Points of Conflict . Georgetown University Press, 2012.

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[75] Pirzada, N. (2022). The Expansion of Turkey’s Medical Tourism Industry.  Voices in Bioethics ,  8 . https://doi.org/10.52214/vib.v8i.9894

[76] Stem Cell Tourism: False Hope for Real Money . Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism , See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis.  Voices in Bioethics ,  3 . https://doi.org/10.7916/vib.v3i.6027

[77] Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation,  New Genetics and Society , 30:2, 141-153, DOI:  10.1080/14636778.2011.574375

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Mifrah Hayath

SM Candidate Harvard Medical School, MS Biotechnology Johns Hopkins University

Olivia Bowers

MS Bioethics Columbia University (Disclosure: affiliated with Voices in Bioethics)

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Risk of ‘genetic discrimination’ by insurance companies is ruining people’s trust in vital medical science

Lecturer in psychology., Swinburne University of Technology

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Brad Elphinstone received funding from a Medical Research Future Fund grant.

Swinburne University of Technology provides funding as a member of The Conversation AU.

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Should you be denied life insurance or have to pay extra if you have a genetic risk for certain diseases? Should insurance companies even have access to your genetic data in the first place? This is known as “genetic discrimination”, a practice already banned in some countries, including Canada .

The Australian Treasury is currently working on a review of the relevant legislation, with insurance industry bodies arguing a total ban would raise life insurance bills.

But this legislation doesn’t just have implications for genetic discrimination. Genetic testing underpins vital branches of medical science. Our research shows the question of who can assess a person’s genomic data directly influences public trust in future genomic research in Australia.

What is genomic research?

Human genomic research holds promise for the development of cures and treatments for cancers and heritable diseases. To achieve this, researchers rely on people willingly donating their genomic data. This is your DNA code derived from something like a blood sample. Genomic data is particularly useful when linked with lifestyle – diet, exercise, habits – and health records.

If researchers have access to this data from thousands of people, they can look for patterns to see if certain genes might be linked to certain illnesses or diseases. Treatments or cures can then be developed to target the gene or genes involved.

To assist with making genomic research viable and accessible for researchers, national-level biobanks exist, such as in the United Kingdom . These biobanks can store data from hundreds of thousands of people.

Australia does not yet have a national biobank, but some researchers in Australia do conduct studies that involve the collection of genomic data.

Can we trust biobanks?

Previous research has found people are generally supportive of genomic research and biobanks. They recognise the potential for new treatments or cures such research can bring.

However, trust in biobanks decreases substantially if there is any commercial involvement in biobank management or research. This poses a problem, as commercial involvement in biobanking is increasingly likely. Running these repositories, conducting research and bringing new treatments to market is expensive.

People who express such distrust often cite concerns that profit will be put ahead of the public good. One common issue is the perceived unfairness of “big pharma” hypothetically making large profits from freely donated genomic data.

Another primary concern, that is often a dealbreaker when it comes to hypothetically donating data, is that data will be sold to insurance companies who will then deny cover or increase premiums.

If people are unwilling to donate to biobanks due to the perceived risk of genetic discrimination from insurance companies, the scope of genomic research may suffer.

People are most trusting of biobanks if they are managed by universities and hospitals, who then also conduct the research. This is because these types of public institutions are not typically seen to be profit driven.

Would Australians trust a biobank?

Our research explored the required conditions for a trusted Australian national biobank. Specifically, we examined what Australians think about genomic research and sources of distrust. We also examined different legal safeguards that could be implemented to enhance trust and willingness to donate.

We started by surveying a statistically representative sample of 1,000 Australians. We found four groups Australians can be categorised into based on their attitudes towards genomic research:

• highly supportive and willing to donate to a national biobank (approximately 23% of the population if you extrapolate from our sample)
• supportive and open to donating but wary of commercial involvement (37%)
• supportive and open to donating but wary of commercial and governmental involvement (26%)
• completely unwilling to donate under any circumstances (14%)

In a follow-up study we interviewed 39 people from these groups. Across the four groups, including those who were willing to donate, there were clear concerns about genetic discrimination from insurers or employers. Concern about corporate profiteering was also widespread. However, respondents maintained a pragmatic view that pharmaceutical companies necessarily need to make some profit.

Based on the interviews, and a third experimental survey, it was clear a national biobank should be managed by a public institution. Additionally, we should have a data access committee comprising relevant experts.

This committee would assess applications from researchers attempting to access the data. For example, data access would be allowed only for researchers from established commercial or public organisations. Additionally, researchers would be compelled to only use data for ethical human health research and make no effort to identify donors.

Overall, Australians generally do support genomic research – they recognise its potential to give us much-needed new medical treatments and even cures.

But this support is undermined if people feel that genetic discrimination is a likely risk for themselves or their blood relatives.

Legislation that reduces this risk targets a main source of distrust that can make people unwilling to donate genomic data. A law preventing genetic discrimination could therefore indirectly benefit genomic research and support for a national biobank, should one exist in the future.

The author would like to acknowledge research collaborators Jarrod Walshe from Swinburne University of Technology, Dianne Nicol from the University of Tasmania and Mark Taylor from the University of Melbourne. The research project was based on a Medical Research Future Fund grant that was awarded to Professor Christine Critchley who sadly passed in 2020.

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First Patient Begins Newly Approved Sickle Cell Gene Therapy

A 12-year-old boy in the Washington, D.C., area faces months of procedures to remedy his disease. “I want to be cured,” he said.

By Gina Kolata

Photographs by Kenny Holston

Gina Kolata visited Kendric and his parents at the hospital in Washington, D.C., when he was having his stem cells extracted

On Wednesday, Kendric Cromer, a 12-year-old boy from a suburb of Washington, became the first person in the world with sickle cell disease to begin a commercially approved gene therapy that may cure the condition.

For the estimated 20,000 people with sickle cell in the United States who qualify for the treatment, the start of Kendric’s monthslong medical journey may offer hope. But it also signals the difficulties patients face as they seek a pair of new sickle cell treatments.

For a lucky few, like Kendric, the treatment could make possible lives they have longed for. A solemn and shy adolescent, he had learned that ordinary activities — riding a bike, going outside on a cold day, playing soccer — could bring on episodes of searing pain.

“Sickle cell always steals my dreams and interrupts all the things I want to do,” he said. Now he feels as if he has a chance for a normal life.

Near the end of last year, the Food and Drug Administration gave two companies authorization to sell gene therapy to people with sickle cell disease — a genetic disorder of red blood cells that causes debilitating pain and other medical problems. An estimated 100,000 people in the United States have sickle cell, most of them Black. People are born with the disease when they inherit the mutated gene for the condition from each parent.

The treatment helped patients in clinical trials , but Kendric is the first commercial patient for Bluebird Bio, a Somerville, Mass., company. Another company, Vertex Pharmaceuticals of Boston, declined to say if it had started treatment for any patients with its approved CRISPR gene-editing-based remedy .

Kendric — whose family’s health insurance agreed to cover the procedure — began his treatment at Children’s National Hospital in Washington. Wednesday’s treatment was only the first step. Doctors removed his bone marrow stem cells, which Bluebird will then genetically modify in a specialized lab for his treatment.

That will take months. But before it begins, Bluebird needs hundreds of millions of stem cells from Kendric, and if the first collection — taking six to eight hours — is not sufficient, the company will try once or twice more.

If it still doesn’t have enough, Kendric will have to spend another month in preparation for another stem cell extraction.

The whole process is so involved and time-consuming that Bluebird estimates it can treat the cells of only 85 to 105 patients each year — and that includes not just sickle cell patients, but also patients with a much rarer disease — beta thalassemia — who can receive a similar gene therapy.

Medical centers also have the capacity to handle only a limited number of gene therapy patients. Each person needs expert and intensive care. After a patient’s stem cells have been treated, the patient has to stay in the hospital for a month. For most of that time, patients are severely ill from powerful chemotherapy.

Children’s National can accept only about 10 gene therapy patients a year.

“This is a big effort,” said Dr. David Jacobsohn, chief of the medical center’s division of blood and marrow transplantation.

Top of the Waiting List

Last week, Kendric came prepared for the stem cell collection — he has spent many weeks in this hospital being treated for pain so severe that on his last visit, even morphine and oxycodone could not control it. He brought his special pillow with a Snoopy pillowcase that his grandmother gave him and his special Spider-Man blanket. And he had a goal.

“I want to be cured,” he said.

Bone marrow stem cells, the source of all the body’s red and white blood cells, are normally nestled in a person’s bone marrow. But Kendric’s doctors infused him with a drug, plerixafor, which pried them loose and let them float in his circulatory system.

To isolate the stem cells, staff members at the hospital inserted a catheter into a vein in Kendric’s chest and attached it to an apheresis machine, a boxlike device next to his hospital bed. It spins blood, separating it into layers — a plasma layer, a red cell layer and a stem cell layer.

Once enough stem cells have been gathered, they will be sent to Bluebird’s lab in Allendale, N.J., where technicians will add a healthy hemoglobin gene to correct the mutated ones that are causing his sickle cell disease.

They will send the modified cells back three months later. The goal is to give Kendric red blood cells that will not turn into fragile crescent shapes and get caught in his blood vessels and organs.

Although it takes just a couple of days to add a new gene to stem cells, it takes weeks to complete tests for purity, potency and safety. Technicians have to grow the cells in the lab before doing these tests.

Bluebird lists a price of $3.1 million for its gene therapy, called Lyfgenia. It’s one of the highest prices ever for a treatment.

Despite the astronomical price and the grueling process , medical centers have waiting lists of patients hoping for relief from a disease that can cause strokes, organ damage, bone damage, episodes of agonizing pain and shortened lives.

At Children’s National, Dr. Jacobsohn said at least 20 patients were eligible and interested. The choice of who would go first came down to who was sickest, and whose insurance came through.

Kendric qualified on both counts. But even though his insurance was quick to approve the treatment, the insurance payments are only part of what it will cost his family.

Chances and Hopes

Deborah Cromer, a realtor, and her husband, Keith, who works in law enforcement for the federal government, had no idea they might have a child with sickle cell.

They found out only when Deborah was pregnant with Kendric. Tests showed that their baby would have a one-in-four chance of inheriting the mutated gene from each parent and having sickle cell disease. They could terminate the pregnancy or take a chance.

They decided to take a chance.

The news that Kendric had sickle cell was devastating.

He had his first crisis when he was 3. Sickled blood cells had become trapped in his legs and feet. Their baby was inconsolable, in such pain that Deborah couldn’t even touch him.

She and Keith took him to Children’s National.

“Little did we know that that was our introduction to many many E.R. visits,” Deborah said.

The pain crises became more and more severe. It seemed as though anything could set them off — 10 minutes of playing volleyball, a dip in a swimming pool. And when they occurred, Kendric sometimes needed five days to a week of treatment in the hospital to control his pain.

His parents always stayed with him. Deborah slept on a narrow bench in the hospital room. Keith slept in a chair.

“We’d never dream of leaving him,” Deborah said.

Eventually the disease began wreaking severe damage. Kendric developed avascular necrosis in his hips — bone death that occurs when bone is deprived of blood. The condition spread to his back and shoulders. He began taking a large daily dose of gabapentin, a medicine for nerve pain.

His pain never let up. One day he said to Deborah, “Mommy, I’m in pain every single day.”

Kendric wants to be like other kids, but fear of pain crises has held him back. He became increasingly sedentary, spending his days on his iPad, watching anime or building elaborate Lego structures.

Despite his many absences, Kendric kept up in school, maintaining an A average.

Deborah and Keith began to hope for gene therapy. But when they found out what it would cost, they lost some of their hope.

But their insurer approved the treatment in a few weeks, they said.

Now it has begun.

“We always prayed this day would come,” Deborah said. But, she added, “We’re nervous reading through the consents and what he will have to go through.”

Kendric, though, is looking forward to the future. He wants to be a geneticist.

And, he said, “I want to play basketball.”

An earlier version of this article misstated the location of a lab. It is in Allendale, N.J., not Allentown.

How we handle corrections

Gina Kolata reports on diseases and treatments, how treatments are discovered and tested, and how they affect people. More about Gina Kolata

Kenny Holston is a Times photographer based in Washington, primarily covering Congress, the military and the White House. More about Kenny Holston