Comment from Cyntegrity
AnonymousSupportBusiness
Summary: Cyntegrity, an RBQM platform provider, supports the FDA's initiative to explore AI in early-phase clinical trials and provides specific recommendations for the pilot's design. They advocate for using retrospective analyses to establish AI reliability, prioritizing safety monitoring as a primary use case, and utilizing side-by-side human-versus-AI comparisons to evaluate performance.
Cyntegrity, an RBQM platform provider with expertise in AI-supported RBQM implementation, submits the following input in response to the FDA's Request for Information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (Docket No. FDA-2026-N-4390). We respond selectively to those questions where we have direct experience and perspective to contribute, specifically from our work developing and operating risk-based quality management (RBQM) solutions for clinical trial sponsors and CROs through the MyRBQM Portal.
We welcome the FDA's initiative to explore how AI can be integrated into early-phase trial management and hope the perspectives below contribute to a well-structured and practically useful pilot.
See attached document for full response.