Medable Presents AI Agent for Automating Trial Master File Processes at JP Morgan Healthcare Conference

Medable announced on Jan 6, 2026 that it will be presenting its trial master file (TMF) AI agent, which automates labor-intensive processes involved in trial document management, at the JP Morgan Healthcare Conference in San Francisco, which is being held from January 12–15. According to the company, the TMF Agency reduces manual effort in document management, and therefore, improves quality and consistency.

Based on Medable’s Agent Studio, an agentic AI platform for clinical development, the TMF Agency “orchestrates TMF workflows end to end” by autonomously intaking documents, classifying files, and extracting metadata (1). These data are prepared for human review before a one-click submission into commonly used eTMF systems (e.g., Veeva Vault, Wingspan, and OpenText). The AI agent is system-agnostic and can be integrated into existing workflows. Human-in-the-loop checkpoints allow for validation, quality control, and audit traceability.

"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, in a press release (1). "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."

How varied is AI’s use in pharma development?

The use of AI and machine learning is rapidly growing in the pharmaceutical industry. Even staff at regulatory agencies are utilizing this new technology. In December 2025, FDA announced it was providing its staff with agentic AI capabilities to create complex AI workflows, harness AI models, and assist staff with multi-step tasks (2). The agency has been committed to embedding AI in its workflow to create more efficient operations.

“FDA's talented reviewers have been creative and proactive in deploying AI capabilities— agentic AI will give them a powerful tool to streamline their work and help them ensure the safety and efficacy of regulated products,” Chief AI Officer Jeremy Walsh stated in a press release (2).

In June 2025, FDA launched Elsa, a generative AI tool for staff use, which was built within a high-security GovCloud environment for staff to securely access internal agency documents (3). FDA is using the large language model tool to accelerate clinical protocol reviews, scientific evaluations, and identify inspection targets.

“Following a very successful pilot program with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,” Makary said in a press release at the time (3). “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”

References

1. Medable. Medable Launches New AI Agent for Automating Clinical Trial Document Management; Presenting at JPM Health. Press Release. Jan. 6, 2026.
2. FDA. FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment. Press Release. Dec. 1, 2025. https://www.fda.gov/news-events/press-announcements/fda-expands-artificial-intelligence-capabilities-agentic-ai-deployment
3. FDA. FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People. Press Release. June 2, 2025. https://www.fda.gov/news-events/press-announcements/fda-launches-agency-wide-ai-tool-optimize-performance-american-people