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March 19, 2026

1:00 pm ET - 2:00 pm ET

Location:

Deploying Digital Twins and Synthetic Data in Evidence Generation

Webinar

March 19, 2026 @ 1:00 pm – 2:00 pm

This webinar will examine the use of digital twins and synthetic data in evidence generation, focusing on (1) their emerging applications across the clinical trial lifecycle, including study design, control arm reduction, and single-arm trials, and (2) regulatory expectations and experience. Panelists will discuss how evidence quality, validation approaches, performance benchmarks, and model interpretability shape decision-making, and reflect on how practical and regulatory considerations influence the adoption of these approaches in clinical research. The discussion will draw on use cases, including synthetic controls and power enhancement strategies, and will include a moderated discussion and time for audience Q&A. 

Panelists:

Moderator: Barbara Bierer, Faculty Director, MRCT Center

AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research
AI Digital Twins and Synthetic Data: Application to Clinical Trials
A Framework for AI Adoption and Oversight in Clinical Research
Framework for Review of Clinical Research Involving AI

Bioethics Collaborative

April 9, 2026

1:00 pm ET - 3:30 pm ET

Location:

hybrid

Use of AI in Clinical Trials – Exploration of Key Legal and Regulatory Issues

April 9, 2026 @ 1:00 pm – 3:30 pm

The Research, Development, and Regulatory Roundtable (R3) is 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. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.

This hybrid meeting is open to sponsors and select guests of the Research, Development, and Regulatory Roundtable.

Topic: Use of AI in Clinical Trials – Exploration of Key Legal and Regulatory Issues

For more information, please email at MRCT@BWH.HARVARD.EDU

Deliverables

Projects

Research, Development, and Regulatory Roundtable (R3)

April 21, 2026

12:00 pm ET - 1:00 pm ET

Location:

Investigator Oversight in Decentralized Trials: New Resources and Practical Tools

 

Webinar

April 21, 2026 @ 12:00 pm – 1:00 pm

Join us on Tuesday, April 21, from 12:00 PM to 1:00 PM ET for a webinar introducing new tools to support investigator oversight in trials with decentralized elements. Developed by the MRCT Center and Medable, in collaboration with the PI-Oversight in DCT task force, these resources reflect cross-sector input and address the evolving responsibilities of investigators in DCT settings. This work builds on the MRCT Center’s prior guidance for IRB/EC review of decentralized trials and continues to expand the DCT project portfolio with practical, ethics-grounded tools.

Moderator: Barbara Bierer, Faculty Director, MRCT Center

IRB/EC Considerations for DCT Review
Ethical Considerations for Decentralized Clinical Trials: Tools, Resources and Best Practices

Bioethics Collaborative

June 8, 2026

12:00 pm ET - 3:30 pm ET

Location:

hybrid

Use of AI in Clinical Trials – Exploration of Key Legal and Regulatory Issues (continued)

June 8, 2026 @ 12:00 pm – 3:30 pm

The Research, Development, and Regulatory Roundtable (R3) is 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. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.

This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.

Topic: Use of AI in Clinical Trials – Exploration of Key Legal and Regulatory Issues (continued). This is the continuation of a discussion first introduced at the April 9, 2026 R3 meeting.

For more information, please email at MRCT@BWH.HARVARD.EDU

Deliverables

Projects

Research, Development, and Regulatory Roundtable (R3)

June 22, 2026

9:00 am ET - 11:00 am ET

Location:

Joint Task Force for Clinical Trial Competency (JTF) Global Biannual Meeting

Meeting

June 22, 2026 @ 9:00 am – 11:00 am

The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively.

Our international team of investigators, educators, and clinical research professionals has developed and/or utilizes a framework that defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research.

Join us on June 22, 2026, 9:00-11:00 AM ET for the Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting to hear about global perspectives on implementing the JTF Framework. Agenda specifics will be posted soon.

To learn more about the JTF Framework: https://mrctcenter.org/clinical-trial-competency/framework/overview/

All registrants will receive slides and a meeting summary after the meeting. This event is free.

Bioethics Collaborative

September 3, 2026

1:00 pm ET - 3:30 pm ET

Location:

hybrid

Meeting of The Research, Development, and Regulatory Roundtable (R3)

September 3, 2026 @ 1:00 pm – 3:30 pm

The Research, Development, and Regulatory Roundtable (R3) is 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. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.

This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.

Topic: TBD

For more information, please email at MRCT@BWH.HARVARD.EDU

Deliverables

Projects

Research, Development, and Regulatory Roundtable (R3)

September 8, 2026

10:00 am ET - 12:30 pm ET

Location:

What’s Mine Is Mine and What’s Yours Is Mine: Data Ownership and Sovereignty 

September 8, 2026 @ 10:00 am – 12:30 pm

Topic: What’s Mine Is Mine and What’s Yours Is Mine: Data Ownership and Sovereignty

This meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor, click here.

November 5, 2026

1:00 pm ET - 3:30 pm ET

Location:

hybrid

Meeting of The Research, Development, and Regulatory Roundtable (R3)

November 5, 2026 @ 1:00 pm – 3:30 pm

The Research, Development, and Regulatory Roundtable (R3) is 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. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.

This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.

Topic: TBD

For more information, please email at MRCT@BWH.HARVARD.EDU

Deliverables

Projects

Research, Development, and Regulatory Roundtable (R3)