Enterprise-Grade AI for Regulated Clinical Development
Smarter, faster, safer clinical trials with agentic AI.
From protocol design to FDA submission, Astraea automates clinical data workflows with multi-agent AI — deployed inside your own environment, where your data never leaves and we never see it. Faster cycles, lower costs, and audit-ready compliance at every step.
30–50%
Faster biometrics cycles
Built for Regulated Trials
Compliance and data control, engineered in.
Audit-ready traceability, controlled execution, and e-signature support built into every workflow by design.
Submission-standard datasets, TFLs, and Define-XML automated end to end against CDISC conventions.
Validated, human-in-the-loop workflows aligned to FDA guidance and Good Clinical Practice expectations.
Forward-deployed inside your own environment. Astraea never stores or sees your clinical data.
Measurable Impact
Overcome your biggest clinical bottlenecks.
Astraea is built around the workflows regulators actually inspect, so every acceleration comes with traceability intact.
Compress the biometrics-to-reporting window in the workflows Astraea automates.
SDTM, ADaM, and Define-XML assets validated against submission conventions.
Applied to a typical 40–60 business-day CSR cycle when Astraea is on the critical path.
Standards-native traceability, controlled execution, and human-in-the-loop approval baked into every workflow.
See it in motion
Automation you can watch work.
Astraea orchestrates specialized AI agents across the biometrics workflow, every step logged, reviewable, and aligned to CDISC standards.
The Mission
The standards-aware execution layer for modern clinical development.
Astraea doesn't replace your biostatisticians, programmers, or medical writers — it gives them a traceable, standards-native execution layer for the regulatory work they actually own: eCRFs, SAP, TFLs, SDTM/ADaM, Define-XML, QC, and submission documents. Every output is automated, inspection-ready, and produced inside your own environment under human supervision — where your data never leaves.
Our Platform
One platform. Four standards-native engines.
Astraea orchestrates specialized AI agents across the full biometrics lifecycle: standards mapping, compliance, evidence synthesis, and statistical execution. All in one controlled, audit-ready system.
Astraea Standards
Automated SDTM, ADaM, Define-XML, and aCRF generation. CDISC-native mapping with Pinnacle 21 validation baked in.
Astraea Compliance
Governed execution, data desensitization, and audit trails aligned with HIPAA, GDPR, 21 CFR Part 11, and FDA guidance.
Astraea Evidence
Extracts and synthesizes evidence from protocols, SAPs, CSRs, and literature to support clinical and regulatory decisions.
Astraea Stats
SAP-driven TLF generation with full traceability, validated statistical outputs wired into submission-ready packages.
How We Help
Solutions built for every stage of clinical development.
Standards & Submission Automation
Automate CRF annotation, SDTM/ADaM mapping, Define-XML, and TLF generation, three clicks from SAP to submission-ready package.
Learn more →End-to-End Biometrics
Full-service biostatistics and programming from protocol design through NDA/BLA submission, inspection-ready deliverables, FDA and EMA aligned.
Learn more →AI-Augmented FSP
Adopt the Astraea platform, operated inside your SOPs, systems, and governance by our embedded experts — until your team owns it.
Learn more →Trial Readiness Estimator
See where Astraea compresses your trial timeline.
Answer four quick questions and get a tailored readiness snapshot — plus the full breakdown for your team.
Where is your trial today?
Astraea supports the full lifecycle, from protocol design through FDA submission.
Ready to transform your clinical trials?
See how Astraea can compress your biometrics-to-reporting window by 30–50% with standards-native, audit-ready AI — running inside your own infrastructure, where your data never leaves your environment.