Protocol-native AI that unifies systems, validates compliance, governs execution, and transforms clinical trial delivery — from protocol design through regulatory submission.
Aurelyn unifies fragmented trial processes into a protocol-driven, inspection-ready system powered by clinical expertise, regulatory intelligence, and responsible AI.
The first closed-loop clinical trial operating system — protocol-native execution, governance, and oversight unified in one continuously validated environment.
Explore EngineContinuous inspection readiness and document intelligence that classifies, scores, and monitors your Trial Master File in real time.
Explore EngineAI-powered validation of clinical evidence, regulatory consistency, and submission quality — so you can trust every claim you file.
Explore AcademyProfessional development and AI education built for the people who run trials — practical, role-aligned, and platform-agnostic.
ExploreEvery action is governed, every document is scored, every claim is traced. The result is a trial that is continuously validated rather than periodically inspected.
The first platform that treats the protocol as the source of truth. It changed how our team thinks about oversight entirely.
Inspection readiness used to be a quarterly fire drill. Now it's a number we watch every morning.
Aurelyn's governance framework gave our board the confidence to deploy AI in regulated workflows.
Responsible deployment in regulated environments demands auditability, traceability, and human-in-the-loop by design.
What recent guidance tells us about validating adaptive, AI-assisted early-phase designs.
Inspection readiness scoring turns the TMF from a filing cabinet into a live quality instrument.
Weekly FDA & EMA updates, AI regulation, and clinical-operations intelligence — written for decision-makers, delivered to your inbox.
See Aurelyn applied to your protocols, your standards, and your inspection timeline.