What You Should Know:
– Medable Inc., the leading technology platform for AI-powered clinical development, today launched Agentic AI for research sites to reduce burden and assist principal investigators (PIs) in oversight and monitoring of electronic clinical outcome assessment (eCOA) data.
– Medable’s newest agent integrates seamlessly within its eCOA system workflows. Released just after Medable’s TMF and CRA agents, its PI Summary Agent continues the company’s rapid rollout of function-specific agentic capabilities and is designed to maximize investigator capacity and accelerate site workflows.
Advancing Remote Trial Oversight with AI-Driven eCOA Intelligence
Medable is on a mission to get effective therapies to patients faster by modernizing how clinical research is designed, executed, and scaled. Its digital clinical trials platform improves speed, reach, and patient access—enabling the development of medicines across thousands of conditions that currently lack effective treatment or cure. Recognized as a Leader in eCOA by Everest Group, Medable’s platform has been deployed in nearly 400 clinical trials across 70 countries and 120 languages, supporting more than one million patients worldwide. The company is privately held, venture-backed, and headquartered in Palo Alto, California.
Medable’s PI Summary Agent is designed to address one of the most persistent challenges in decentralized and hybrid trials: investigator oversight of remotely captured data. The AI-powered agent continuously monitors participant-reported outcomes collected via eCOA, generating concise, investigator-ready participant summaries while flagging the most clinically relevant data points. At the same time, investigators retain full access to underlying source data, supported by human-in-the-loop controls to ensure transparency, traceability, and regulatory confidence.
By surfacing critical participant data in near real time, the PI Summary Agent enables investigators and sponsors to review eCOA inputs proactively—without disrupting site workflows, participant activity, or ongoing trial operations. This approach streamlines oversight while maintaining the rigor regulators expect from modern clinical trials.
“Regulators expect satisfactory oversight of remotely captured data, which traditionally forces principal investigators to manually verify content across multiple reports and systems,” said Pamela Tenaerts, Chief Medical Officer at Medable. “Our agent centralizes that effort for eCOA data, summarizing participants’ most recent inputs to make remote oversight seamless.”
By combining AI-driven summarization with investigator control and auditability, Medable continues to push decentralized clinical trials toward a future that is faster, more scalable, and more resilient—without compromising scientific or regulatory standards.
