Medable Releases New AI Agent to Automate Trial Master File Processing
Palo-Alto based Medable has launched a new AI agent to automate the trial master file (TMF) process, one of the most labor-intensive components of clinical research operations. The announcement comes just ahead of the 44th annual J.P. Morgan Healthcare Conference in San Francisco, where CEO Dr. Michelle Longmire is scheduled to showcase the agent portfolio to select partners and present the company’s broader agentic strategy for AI-powered clinical development.
The TMF Agent is the second in Medable’s AI agent portfolio, following the release of its CRA Agent in late 2025. Both agents are built on the company’s Agent Studio, a system-agnostic platform designed to integrate with standard eTMF and clinical operations systems, including Veeva Vault, Wingspan, and OpenText. The TMF Agent automates ingestion, classification, metadata extraction, and pre-submission preparation of trial documents. According to Medable, this reduces the need for manual reconciliation work that often consumes over one-third of clinical data managers' and CRAs’ time.
Internally collected Medable data cited in the release indicates that more than 95% of TMF-related documents are still handled manually across the industry. The new AI agent is positioned to address these inefficiencies by introducing full workflow orchestration and human-in-the-loop validation to preserve auditability and compliance.
What’s Next
The company plans to release more specialized agents throughout 2026, as it doubles down on modular, AI-based automation to reduce clinical trial timelines. The stated long-term aim is to compress the trial lifecycle—currently estimated at 10 to 15 years in many drug development programs—down to under one year.
Medable’s also provides infrastructure for electronic clinical outcome assessments (eCOAs), supporting standardized patient and clinician-reported data collection within clinical trials. Medable’s eCOA+ system delivers electronic outcome assessments through a library of pre-validated instruments and integrates with eConsent, telehealth, and sensor data tools. It supports both personal and provisioned devices and is deployed across over 70 countries in 120 languages.
Building on that foundation, in mid-2025 Medable introduced a digital long-term follow-up model for cell and gene therapy studies, designed to meet FDA requirements for 15-year safety monitoring.
Topic: Next-Gen Tools
