Practical tools help investigators fulfill oversight responsibilities when trial activities take place beyond traditional research sites

Medable Inc., a leading provider of agentic clinical development technology, and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) today announced new resources for sponsors and investigators. The tools will be available beginning September 23, 2026.

The resources and practical tools help sponsors and investigators determine which trial activities can appropriately take place closer to participants and establish the proportionate oversight, communication, and escalation processes needed to support them. The decentralized model gained traction during the pandemic and has since evolved into a strategic priority for drug developers seeking to improve patient recruitment, retention, and diversity. In fact, trials incorporating decentralized components increased by nearly one-third from 2021 to 2022 alone.

The “Proportionate Oversight in Decentralized Trials: New Resources and Practical Tools” include:

• A proportional oversight framework
• An approach to optimize DCT elements
• A model instruction sheet for local healthcare providers
• A set of illustrative scenarios covering roles and responsibilities in common clinical situations from withdrawal requests to serious adverse events

“Decentralized approaches can make clinical research more accessible to participants, but moving activities beyond the research site requires clarity about roles, responsibilities, and appropriate oversight,” said Dr. Barbara Bierer, Professor of Medicine at Harvard Medical School and Faculty Director of the MRCT Center. “These resources are designed to help sponsors and investigators make thoughtful, risk-based decisions and give local healthcare providers clear direction when they are asked to support a research participant.”

The goal of these resources is to enable more trial activities to occur closer to participants when appropriate, while maintaining participant safety and research integrity. Medable and the MRCT Center will host a webinar covering these oversight resources and how best to use them on Sept 24th – register here.

“Investigator oversight cannot be an afterthought in decentralized trials; it has to be designed in from the start and calibrated to real risk,” said Dr. Pamela Tenaerts, Chief Medical Officer at Medable. “At Medable, we continually look for ways to make decentralized approaches easier to adopt and operationalize, and collaboration is essential to that effort. Together with the MRCT Center, we’ve translated expertise into practical tools that can help sponsors and investigators bring more trial activities closer to participants with the appropriate oversight in place.”

About the MRCT Center

The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) is a research and policy center that advances the integrity, safety, and rigor of global clinical trials. As an independent convener, it brings together industry, academia, regulators, ethics committees, investigators, patients, and patient advocates to address problems no single organization can resolve alone. Working toward consensus, it publishes freely available guidance and tools, including a toolkit to streamline the ethics review of decentralized trials, guidance for achieving representation in clinical research, and training materials for ICH E6(R3). Learn more at mrctcenter.org.

About Medable

Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was named a Leader in eCOA by Everest Group in 2025. Learn more at medable.com.

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