Medable has launched a new artificial intelligence-powered agent designed to automate trial master file (TMF) workflows, aiming to reduce the manual burden of clinical trial document management and improve data quality and consistency.

The Palo Alto-based clinical development technology company said its new TMF Agent automates document ingestion, classification and preparation for submission into electronic trial master file systems, addressing one of the most labor-intensive and costly areas of clinical research.

Clinical teams routinely manage thousands of documents each month across multiple systems. Medable said internal data shows more than 95% of TMF documents are still processed manually, contributing to backlogs, inconsistencies and quality risks. Industry research cited by the company suggests manual document reconciliation consumes at least one-third of clinical data managers’ and clinical research associates’ time.

The TMF Agent is built on Medable’s Agent Studio platform and is designed to orchestrate TMF workflows end to end. According to the company, the agent autonomously ingests documents from shared inboxes, file drives and other upstream sources, classifies files, extracts metadata and prepares documents for human review before one-click submission into commonly used eTMF systems.

Medable said the agent is system-agnostic and integrates with platforms including Veeva Vault, Wingspan and OpenText. Human-in-the-loop checkpoints are embedded throughout the workflow to support validation, quality control and audit traceability, which the company said is critical for regulatory compliance.

Michelle Longmire, ceo and co-founder of Medable, said the company is focusing on applying AI in areas where manual work creates bottlenecks across clinical development.

“We are applying AI to improve quality and remove bottlenecks in clinical development to enable highly skilled professionals to perform more strategic work to move the needle on clinical development,” Longmire said. “Medable agents make trial systems work smarter by removing the friction between document management and regulatory submission.”

She added that the company plans to expand its portfolio of AI agents to address additional operational challenges in clinical trials while also enabling customers to develop their own agents using the Agent Studio platform.

TMF management remains a persistent challenge for sponsors and contract research organizations, particularly as trials grow in complexity and generate increasing volumes of documentation. Regulatory expectations for TMF completeness, accuracy and inspection readiness continue to rise, placing additional pressure on clinical operations teams.

By automating document handling while maintaining human oversight, Medable said its TMF Agent is designed to help organizations reallocate staff time away from repetitive administrative tasks and toward higher-value clinical and operational activities.

Longmire is scheduled to present on Medable’s agent-based AI approach at the 44th annual J.P. Morgan Healthcare Conference in San Francisco. The company said it will also showcase its agent portfolio to selected partners at the event and hold discussions related to partnerships and product demonstrations.