White Paper

Reshaping Clinical Trial Workflows: Agentification of TMFs

Reshaping Clinical Trial Workflows: Agentification of TMFs

Reshaping Clinical Trial Workflows: Agentification of TMFs

Pages 8 Pages

This insight brief explores how agentic AI is transforming Trial Master File (TMF) management within clinical research. Unlike traditional automation, agentic AI systems can autonomously plan, reason, adapt, and execute tasks, enabling more intelligent document classification, quality control, compliance monitoring, and workflow optimization. IQVIA demonstrates how AI-driven TMF processes can significantly improve operational efficiency, document quality, compliance readiness, and speed while reducing the manual burden associated with managing thousands of trial documents. The paper also emphasizes the importance of maintaining “experts-in-the-loop” governance, ensuring human oversight remains central as organizations increasingly leverage AI to improve clinical trial execution and generat

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