About Astraea
Transforming clinical research with standards-aware AI.
Astraea is an AI-native clinical trial platform built by scientists, engineers, and industry veterans, redefining how modern biometrics, compliance, and submissions work together.
01 · Dream it
Reimagine how clinical trials can work.
We envision a world where life-saving treatments reach patients faster, powered by intelligent automation, scientific precision, and FDA-aligned governance. Astraea began as that vision: a standards-aware AI layer between protocol intent and regulator-ready evidence.
02 · Build it
Turn AI into your clinical co-pilot.
We built Astraea to execute critical trial tasks with full human supervision, 99%+ precision on validated outputs, and FDA-aligned compliance by design. Our multi-agent architecture is redefining the clinical trial lifecycle step by step.
03 · Grow it
Scale innovation with every study.
From biotech startups entering first-in-human trials to top-10 global pharma, Astraea empowers teams to grow without compromise, faster submissions, higher success rates, and sustainable growth across portfolios.
Who We Are
An AI-native clinical trial company, built by people who've lived the workflow.
Astraea is a Y Combinator-backed clinical trial automation platform accelerating the full trial lifecycle, from protocol design to FDA submission, using compliant, enterprise-grade AI designed for modern healthcare.
We're founded and staffed by biostatisticians, clinical programmers, AI engineers, and former sponsor-side leaders. We've spent careers inside SDTM, ADaM, SAPs, and CSRs, and we built Astraea to fix the handoffs, not to replace the experts.
Our platform partners with pharmaceutical sponsors, biotech innovators, and research institutions to streamline operations and deliver FDA-ready results with precision and speed.
Our Mission
Empower clinical innovators with intelligent, compliant, and scalable AI that accelerates the journey from discovery to regulatory success.
Our Vision
Become the trusted AI engine behind every successful clinical trial, where automation enhances accuracy, compliance strengthens confidence, and science moves faster than ever.
Our Technology
Built for the regulated workflows that matter.
At Astraea's core is a multi-agent AI architecture purpose-built for the clinical ecosystem.
Trust Through Transparency
Every action Astraea takes is logged, versioned, and reviewable. Audit readiness is a property of the system, not a retrofit.
Speed Through Intelligence
Modular agents for annotation, standards mapping, compliance, evidence synthesis, and statistical execution, all coordinated.
Safety Through Compliance
Built around CDISC, 21 CFR Part 11, HIPAA, GDPR, and FDA guidance, not retrofitted. Compliance is a design constraint.
Precision Through Expertise
Built with biostatisticians and clinical programmers in the room, not just AI researchers. Models are grounded in real biometrics work.
Join us in reshaping clinical development.
Whether you're a sponsor, a CRO, or a scientist who believes AI can move clinical science faster, we'd love to talk.