Insight Brief
Reshaping clinical trial workflows: Agentification of TMFs
Harnessing agentic AI models and ‘experts-in-the-loop’ to boost the speed, efficiency and quality of TMFs
May 13, 2026

Advances in agentic AI are reshaping how Trial Master Files (TMFs) are managed—transforming them from manual, resource-intensive repositories into intelligent, insight-generating assets. By combining autonomous AI agents with “experts-in-the-loop,” agentification enables faster document ingestion, classification, quality control, and compliance monitoring while maintaining rigorous regulatory oversight and inspection readiness. IQVIA’s open-architecture approach integrates seamlessly with sponsor environments, helping organizations manage growing document volumes, reduce errors, improve TMF recency, and accelerate critical milestones such as study startup and site activation. The result is a more scalable, efficient, and insight-driven TMF ecosystem that supports smarter decision-making and faster delivery of treatments to patients.

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