Medable Inc. (Palo Alto, CA) has announced its Trial Master File (TMF) Agent, which brings artificial intelligence (AI) and automation to the labor-intensive processes required for trial document management. According to the company's press release, "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."
According to internal Medable data, more than 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 on 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. Longmire will be presenting at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco (12-15 January).
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