Medable Debuts AI Agent for Automating Trial Master File (TMF) Processes

New capability frees up human capital from one of the biggest labor costs in clinical research

Medable CEO Michelle Longmire to present the power of AI agents at JP Morgan Health

PALO ALTO, Calif.--(BUSINESS WIRE)--Medable Inc., the leading technology platform for AI-powered clinical development, today announced its TMF Agent, which brings artificial intelligence and automation to the labor-intensive processes required for trial document management. TMF Agent significantly improves quality and consistency while drastically reducing the manual effort in document management. It is built on Medable’s Agent Studio, the industry’s first agentic AI platform for clinical development.

Clinical teams manage thousands of documents each month, and – according to internal Medable data – at least 95% are still processed manually, requiring significant time and effort while also introducing inconsistencies, potential quality issues, and backlogs of work. Industry research reveals that manual document reconciliation between trial systems consumes at least one-third of clinical data managers’ and clinical research associates’ time.

Medable’s new TMF Agent orchestrates TMF workflows end to end, autonomously ingesting documents from shared inboxes, drives, and other upstream sources, classifying files, extracting metadata, and preparing them for human review prior to one-click submission into commonly used eTMF systems, including Veeva Vault, Wingspan, and OpenText. Notably, Medable agents are system-agnostic, seamlessly integrating into existing clinical workflows. They also include human-in-the-loop checkpoints for validation, quality control, and audit traceability, ensuring confidence and compliance.

"We are applying AI to improve quality and remove bottlenecks in clinical development to enable highly skilled progressions to perform more strategic work to move the needle on clinical development," said Dr. Michelle Longmire, Medable CEO and Co-Founder. "Medable agents make trial systems work smarter by removing the friction between document management and regulatory submission. We will continue building agents that address the most difficult clinical trial challenges while also enabling customers to build their own with Studio."

Dr. Michelle Longmire will be presenting at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. Medable will also showcase its agentic portfolio to select partners at the event and be available for partnership discussions and product demonstrations upon request.

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 Leader in eCOA by Everest Group and 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.