Comment from Florence Healthcare

Florence Healthcare appreciates the opportunity to provide comments on FDA’s Request for Information regarding the “AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program” (Docket No. FDA-2026-N-4390). Please find Florence’s formal response attached. Our submission reflects a site-centered perspective on what will be required to make AI-enabled real-time clinical trials practical, trustworthy, and scalable. Many of the signals needed for real-time oversight originate in the workflows performed at research sites, where trial execution, documentation, escalation, and patient-facing activities actually occur. For that reason, we believe FDA’s pilot should account for how operational data is captured and structured at the point of care and point of execution, not only after it has been transferred into sponsor systems. Florence recommends that FDA prioritize structured real-time signal sharing, privacy-preserving and federated interoperability models, proportional governance for lower-risk operational AI, and workflow infrastructure that reduces latency between site execution and regulatory visibility. We also emphasize that trustworthy AI depends not only on model performance, but on the quality, timeliness, traceability, and auditability of the operational data generated during day-to-day trial conduct. Florence supports FDA’s efforts to modernize clinical development and believes the proposed pilot represents an important opportunity to reduce site burden, improve safety escalation, make execution risks visible earlier, and support more timely, evidence-based decisions while preserving human oversight, regulatory rigor, and participant protection. We look forward to continued engagement with FDA and industry stakeholders as this important work advances.