Comment from OmniScience Inc.

OmniScience supports FDA’s Real-Time Clinical Trials (RTCT) initiative, a primary use case of interest within this RFI. This is a rare and exciting opportunity to modernize clinical development. We believe the proposed pilot is well focused on real-time signal detection, and we appreciate the opportunity to provide input on FDA's proposed pilot program. We are grateful for FDA’s vision and courage to lead a program to use AI to transform the clinical development process - to shorten timelines and get more medicines to patients - faster, at lower cost, without reducing the evidentiary standards that protect patients. FDA's RFI confirms the agency’s goal to accelerate the clinical trial process and identifies the core bottlenecks in early development: uncertainty in dosing, safety, and efficacy; limited patient populations; inefficient progression decisions; long timelines; and high resource demands. OmniScience appreciates the opportunity to respond to FDA's Request for Information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (Docket No. FDA-2026-N-4390). OmniScience’s comments are enclosed in the attached PDF document. OmniScience is prepared to serve as a technology partner for continuous data standardization and real-time monitoring. We look forward to the release of the selection criteria in July 2026. Respectfully submitted, Angela Holmes, CEO OmniScience, Inc.