Comment from Sheilah Johnson
AnonymousOtherBusiness
Summary: Aurelyn AI Clinical, a clinical research technology company, provides information about their "Trial OS" platform. They argue for a shift toward protocol-native, governance-driven operating systems that integrate clinical operations, safety, and regulatory compliance into a single, continuously validated environment.
Docket No. FDA-2026-N-4390 for “AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information.”
At Aurelyn AI Clinical, we believe the future of clinical research lies in moving beyond isolated AI tools toward protocol-native, governance-driven operating systems that continuously validate trial activities, safety signals, operational risks, and regulatory compliance in real time.
https://fda-2026-n-4390-0001.aurelynaiclinical.org/
https://clinicalos.aurelynaiclinical.org/
Aurelyn Trial OS was designed to transform the protocol from a static document into executable intelligence—connecting clinical operations, safety, quality, regulatory, and data systems into a single, continuously validated environment that supports faster, higher-quality decisions while maintaining inspection readiness and regulatory compliance.