Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

What Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard does

The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) is a non-profit academic research center founded in 2009 and headquartered at 75 Francis Street, Boston, MA (with a secondary office in Cambridge), operating as a division within Brigham and Women's Hospital's Department of Global Health Equity and affiliated with Harvard Medical School. The center engages diverse stakeholders — regulators, biopharmaceutical sponsors, institutional review boards, investigators, academics, and patient advocates — to develop ethics, quality, and inclusion solutions for global clinical trials, with active operations spanning the United States, the European Union, and five Sub-Saharan African countries (Nigeria, Rwanda, Zimbabwe, Tanzania, Kenya) through the TRACE consortium. It employs 11-50 staff and is governed by Faculty Director Barbara E. Bierer, MD, Faculty Co-Director Mark Barnes, JD, LLM, and Executive Director Sarah White.

Name

Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

Legal name

The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

Website

https://mrctcenter.org

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

The MRCT Center of Brigham and Women's Hospital and Harvard is a non-profit academic research center that develops ethics frameworks, guidance, and toolkits to improve the quality, transparency, and inclusion of global clinical trials for regulators, pharma sponsors, IRBs, and patients.

Ownership category

akta.pro rank

Product category

Clinical Research Ethics & Regulatory Guidance

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Research Ethics & Human Subjects Protection Authorities (IRB/REC Oversight) (HLAJACAG)

akta.pro secondary industries

Clinical Trials Authorization & Oversight (GCP) (HLAJADAF), Investigator & Site Training / GCP Support (HLAGACAF), Healthcare & Clinical Professional Development (CME/CE) (EDAGANAJ)

Keywords

• Clinical trial ethics
• Regulatory guidance frameworks
• Clinical research training
• Patient engagement toolkits
• Research capacity building

Headquarters

HQ city

Boston

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Others

Revenue model

1. Sponsorship Revenue: The MRCT Center operates primarily through sponsorship from pharmaceutical companies, biotech firms, healthcare organizations, and foundations. The R3 forum and various projects are sponsored by organizations including Advarra, Amgen, Bristol Myers Squibb, Eli Lilly, Gates Foundation, Johnson & Johnson, Merck, PhRMA, Sanofi, Takeda, Vertex, and others.
2. Grant Funding: The center receives grant funding from government agencies such as the FDA (Scientific Conference Grant R13) and NIH National Library of Medicine for specific research projects and conference series.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels6 records

Core offering

The MRCT Center develops and disseminates ethical frameworks, guidance documents, toolkits, and training resources to improve the ethics, quality, regulatory compliance, and inclusion of multi-regional clinical trials globally. Its offerings include the CDISC-standardized Clinical Research Glossary, the Framework for Review of Clinical Research Involving AI, the R3 Forum for pre-competitive regulatory discussion, the TRACE project for ethics capacity building in Sub-Saharan Africa, and sponsor/IRB/participant toolkits such as the Pregnancy Privacy Protections Toolkit and the Long-Term Follow-Up Toolkit for Gene Therapies.

Product overview

The MRCT Center is a research and policy center (not a software product company) that offers a portfolio of ethical frameworks, guidance documents, toolkits, and professional forums for global clinical trials. The center's offerings are organized into four primary focus areas: Clinical Trials & Research (including AI oversight, decentralized trials, consent reform, and health literacy), Capacity Building (including training, competency frameworks, and regulatory engagement), Quality & Transparency (including data sharing, safety surveillance, and policy engagement), and Patients & Participants (resources and toolkits for research participants). Key products include the CDISC-standardized Clinical Research Glossary, the AI Framework for IRB Review, the Including Young People in Research Toolkit, the Informed Consent Reimagined project, and the R3 Forum. The center does not offer a commercial software product but rather provides guidance, frameworks, and educational resources for the clinical research community.

Differentiator

Problem solved

Functional benefit

Brands

• Research, Development, and Regulatory Roundtable (R3): A forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. A cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.
• Health Literacy in Clinical Research
• Joint Task Force for Clinical Trial Competency
• Return of Individual Results
• Clinical Research Glossary
• TRACE (Trial Regulatory and Clinical Ethics Optimization)

Products and services

• Clinical Research Glossary CDISC global standard providing 216 plain-language definitions for terms used across the clinical research enterprise, intended for sponsors, IRBs, investigators, and participants.
• Framework for Review of Clinical Research Involving AI Structured framework for IRBs and oversight entities to evaluate protocols involving artificial intelligence in human-participant clinical research, addressing algorithmic bias, adaptive learning, and data identifiability.
• Research, Development, & Regulatory Roundtable (R3) Sponsored forum for pre-competitive discussion of regulatory oversight of clinical trials, drug and device development, and human subjects research, coordinated with Ropes & Gray LLP for sponsor organizations.
• Bioethics Collaborative Forum encouraging discussion of bioethical issues among stakeholders in global clinical trials for drug and device development.
• TRACE (Trial Regulatory and Clinical Ethics Optimization) Capacity-building partnership working to strengthen clinical trial ethics capacity across Sub-Saharan Africa, with the MRCT Center as technical lead.
• Childhood Cancer Academic-Industry Collaborative Platform Trials (C3PT) Toolkit Position Narrative and Toolkit providing guidance on the design and delivery of platform trials for pediatric oncology, including PIPs/iPSPs templates, IP considerations, and operational planning.
• Pregnancy Privacy Protections for Participants (P4) Toolkit Resources for research teams, IRBs, and participants to protect the privacy of pregnancy data in clinical trials.
• Long-Term Follow-Up Toolkit for Gene Therapies Practical guidance and best practices for long-term follow-up studies for investigational and approved gene therapies, covering design, conduct, and reporting.
• Joint Task Force for Clinical Trial Competency Project promoting harmonized competencies for training and qualification of clinical research professionals, defining knowledge, skills, and attitudes across eight competency domains.
• Including Young People in Research Toolkit Tools, checklists, and considerations supporting the intentional inclusion of children and adolescents in research and research-related activities.
• For Patients and Participants Resources Resources for patients, participants, and caregivers including Participant Bill of Rights, research information for young people, clinical research glossary, and decision-making guides.
• Informed Consent, Reimagined Multi-dimensional project focused on improving the informed consent process for all those involved in clinical trials.
• Return of Individual Results Principles, recommendations document, and toolkit for returning individual results to study participants.
• Investigator Oversight in Decentralized Trials Resources Four resources for investigator oversight in decentralized clinical trials, including a proportional oversight framework, DCT optimization approach, model instruction sheet for local healthcare providers, and illustrative scenarios.

Quantifiable outcome

• 216 plain-language definitions standardized as CDISC global standard
• +2 more outcomes

Named customers20 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature3 records

Partnerships

Eleven partnerships are on record, tiered core and major.

• WCG (WCG Clinical)coreStrategic or Co-development Partner · 24 June 2025Co-developed the Framework for Review of Clinical Research Involving AI with WCG in collaboration with a diverse, multi-stakeholder task force. This framework provides IRBs and oversight entities a structured approach to evaluating protocols involving AI in research with human participants.
• VivlimajorStrategic or Co-development Partner · 1 October 2024MRCT Center and Vivli are co-organizing a half-day session on October 22, 2026 focused on data sharing broadly, including a panel on the European Health Data Space (EHDS). Vivli is a nonprofit organization that promotes data sharing for public health.
• ITCC (Innovative Therapies for Children and Adolescents with Cancer)majorStrategic or Co-development Partner · 1 October 2024Collaborating with ITCC on the Childhood Cancer Academic-Industry Collaborative Platform Trials (C3PT) Position Narrative and Toolkit, guidance for those planning and delivering platform trials for pediatric oncology.
• Blood Cancer UnitedmajorStrategic or Co-development Partner · 1 October 2024Collaborating on C3PT (Childhood Cancer Academic-Industry Collaborative Platform Trials) toolkit development for pediatric oncology platform trials.
• Children's Oncology GroupmajorStrategic or Co-development Partner · 1 October 2024Collaborating on C3PT (Childhood Cancer Academic-Industry Collaborative Platform Trials) toolkit development for pediatric oncology platform trials.
• MedablemajorTechnology or Integration · 1 September 2024MRCT Center and Medable developed four new resources for investigator oversight in clinical trials with decentralized elements (DCTs), including a proportional oversight framework, an approach to optimize DCT elements, a model instruction sheet for local healthcare providers, and illustrative scenarios covering roles and responsibilities.
• TRACE Consortium (Nigeria, Rwanda, Zimbabwe, Tanzania, Kenya)coreStrategic or Co-development Partner · 1 January 2024MRCT Center serves as technical lead for the TRACE (Trial Regulatory and Clinical Ethics Optimization) project, a partnership working to strengthen clinical trial ethics capacity across Sub-Saharan Africa. The center supports each country's distinct needs in capacity building and financial sustainability.
• European Data Protection BoardmajorStrategic or Co-development Partner · 28 September 2021MRCT Center submitted comments on EDPB Guidelines 04/2021 on Codes of Conduct as Tools for Transfers, contributing to GDPR guidance development for clinical research data processing.
• International Children's Advisory Network (iCAN)majorStrategic or Co-development Partner · 1 January 2021Collaborative partnership with iCAN for creating videos featuring youth addressing their involvement in clinical research and what they want adults to know. Special thanks to Dr. Gianna 'Gigi' McMillan for collaborative efforts.
• U.S. Food and Drug Administration (FDA)coreStrategic or Co-development Partner · 1 January 2021FDA supported the Advancing International Pediatric Clinical Research webinar series (R13) as part of a Scientific Conference Grant Program. The FDA R13 grant supported the 5-part virtual conference series.
• Ropes & Gray LLPcoreStrategic or Co-development Partner · 1 January 2018Ropes & Gray LLP is a cooperative partner in coordinating the R3 (Research, Development, & Regulatory Roundtable), a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. The law firm hosts meetings at their Boston office.

Scale indicators4 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Advarra: Commercial IRB and research services provider (an R3 sponsor and partner of MRCT) with overlapping ethics review, site training, and DCT capabilities—competes for the same sponsor-backed convening influence.
• Critical Path Institute (C-Path): Non-profit that collaborates with FDA and industry on clinical trial data standards and drug development tools; comparable academic-convening model with regulatory and consortia focus.
• Vivli: Non-profit data-sharing platform for clinical trial data; co-organizes sessions with MRCT and overlaps directly on the center's data-sharing and EHDS policy work.
• TransCelerate BioPharma: Non-profit consortium of 20+ pharma companies that develops shared clinical trial solutions, including GCP training and site qualification—same convening-plus-toolkit model that competes with MRCT's JTF competency and R3 work.
• WCG (WCG Clinical Services): Commercial IRB and clinical trial technology vendor that co-developed MRCT's AI Framework; directly comparable in IRB review services and acts as both partner and competitor in DCT/AI oversight tools.
• Clinical Trials Transformation Initiative (CTTI): Multi-stakeholder non-profit hosted at Duke that convenes industry, regulators, and academics to develop evidence-based clinical trial practices — directly comparable convening model to MRCT with overlapping pre-competitive policy focus.
• Association of Clinical Research Professionals (ACRP): Non-profit membership organization for clinical research professionals that trains and certifies CRCs/CRAs—an R3 sponsor that works in parallel with MRCT's Joint Task Force competency framework.

Emerging players

• Medable: Decentralized clinical trial technology vendor that co-developed DCT oversight resources with MRCT—an emerging platform player intersecting with MRCT's thought-leadership role in DCT adoption.

Broad incumbents

• Drug Information Association (DIA): Global life sciences membership association that runs conferences, training, and publishes regulatory guidance—broader in scope than MRCT but overlapping on clinical research professional education and regulatory engagement.

Others

• PhRMA: Industry trade association whose working groups issue pre-competitive clinical trial and policy positions—an R3 sponsor and parallel advocacy body that engages FDA and EMA on similar issues.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCgIfaVwWL-_xQR-d5OZzoTQ/featured
• LinkedInlinkedin.com/company/10894988

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard