Comment from The PPD clinical research business of Thermo Fisher Scientific
AnonymousSupportBusiness
Summary: PPD, the clinical research business of Thermo Fisher Scientific, provides a detailed response to the FDA's Request for Information regarding the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. They advocate for a structured, risk-based pilot that focuses on specific high-priority use cases like oncology dose escalation and rare disease trials while emphasizing human oversight, data integrity, and scalable governance.
PPD, the clinical research business of Thermo Fisher Scientific, submits the attached formal response to the U.S. Food and Drug Administration’s Request for Information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (Docket No. FDA-2026-N-4390). Our submission addresses Sections A. Challenges and B. Potential of AI.