Medable Inc., a leader in AI-driven technology for clinical development, has introduced its TMF Agent, a new solution designed to bring artificial intelligence and automation to the complex and labor-intensive process of trial document management. Built on Medable’s Agent Studio, the industry’s first agentic AI platform for clinical development, TMF Agent aims to improve the accuracy, consistency, and efficiency of managing thousands of documents required for clinical trials, while significantly reducing the manual effort involved.
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Clinical teams handle large volumes of trial documents each month, and internal Medable data indicates that around 95 percent of these files are still processed manually. This manual workflow is time-consuming, introduces variability, and increases the risk of errors and backlog in trial documentation. Research shows that reconciling documents between trial systems can consume at least one-third of the time of clinical data managers and clinical research associates.
Medable’s TMF Agent automates trial master file workflows from start to finish. It can ingest documents from shared inboxes, drives, and other sources, classify files, extract metadata, and prepare them for human review before submission to widely used electronic TMF systems such as Veeva Vault, Wingspan, and OpenText. The system-agnostic design allows the agents to integrate seamlessly with existing clinical workflows. Human-in-the-loop checkpoints are incorporated to ensure quality control, regulatory compliance, and audit traceability, giving teams confidence in the automation process.
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Dr. Michelle Longmire, CEO and Co-Founder of Medable, stated that the company is using AI to reduce bottlenecks in clinical development and free skilled professionals to focus on more strategic work that advances trials. She emphasized that Medable agents help trial systems operate more efficiently by removing friction between document management and regulatory submission. Dr. Longmire added that Medable will continue expanding its agentic solutions to tackle complex clinical trial challenges while allowing customers to create custom agents using Agent Studio.
Dr. Longmire is scheduled to present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. At the event, Medable will demonstrate its agentic portfolio to select partners and is available for partnership discussions and product demonstrations upon request.
This launch positions Medable to redefine how trial documentation is managed, leveraging AI to improve both quality and efficiency while supporting the evolving needs of clinical development teams worldwide.
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