Comment from Sajan Sanjay Pandya
AnonymousSupportBusiness
Summary: Sajan Pandya, a Regulatory Affairs Specialist at Encore Medical Inc., supports the proposed AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The commenter argues that the program should explicitly evaluate and incorporate "regulatory infrastructure readiness" as a core dimension, proposing a specific four-pillar governance framework (IPRG) to ensure AI tools are supported by robust compliance and operational structures.
This comment responds to the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program RFI (Docket No. FDA-2026-N-4390, 91 FR 23100). Drawing on operational experience managing a multi-site IDE pivotal trial (PERFORM, IDE G220115), this comment introduces the Integrated Prospective Regulatory Governance (IPRG) framework and argues that regulatory infrastructure readiness should be an explicit evaluation dimension in the pilot program's design. Detailed responses to specific RFI questions are provided in the attached document, organized by the RFI's category and number structure.