Smarter TMFs: Solving Today's Challenges While Preparing for an AI-Enabled Future

About this session

Part of Session 4, Track D: AI in TMF Management (Chair: Marion Mays, Jerion Consulting).

Overcoming persistent Trial Master File (TMF) challenges remains critical to ensuring inspection readiness, data integrity, and regulatory confidence. Our presentation focuses on practical, standards-driven approaches sponsors and vendors use to address common TMF pain points, including unclear ownership, delayed and inconsistent filing, quality gaps, and limited cross-functional oversight. Building on these foundational practices, the session explores how artificial intelligence (AI) and machine learning can supplement existing TMF processes to improve efficiency, visibility, and quality,without compromising compliance. Attendees will learn how structured data, standardized metadata, transparent algorithms, and human-in-the-loop controls enable AI to support document classification, quality monitoring, and risk-based TMF management. By emphasizing governance, traceability, and alignment with data standards, this presentation highlights how organizations can responsibly integrate AI to strengthen TMF oversight, improve decision-making, and advance TMF maturity while maintaining regulatory trust

Speakers

• AG

  Angie Gill

  Phlexglobal

  Speaker

• CA

  Christina Allen

  Daiichi Sankyo

  Speaker

• MM

  Marion Mays

  Jerion Consulting

  Chair