Comment from Sheilah Johnson
AnonymousSupportBusiness
Summary: Aurelyn AI Clinical is submitting information regarding their "Aurelyn Trial OS" and "Aurelyn Clinical Engine" in response to the FDA's Request for Information. They argue that their platform provides a protocol-native, governance-driven operating system that optimizes clinical research by continuously validating safety, compliance, and operational risks in real time.
Comment:
Docket No. FDA-2026-N-4390 for AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information.
The link below is where responses demonstrating how Aurelyn Trial | OS and the Aurelyn Clinical Engine directly address the FDA's Request for Information — across pilot design, evaluation metrics, and the trustworthy-AI principles of the NIST AI Risk Management Framework.
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.