Agentic AI platform for clinical trial biometrics automation deployed inside the sponsor's own environment.
Astraea automates the full biometrics-to-submission workflow for pharmaceutical clinical trials—including SDTM, ADaM, Define-XML, TFLs, QC, and FDA submission documents—deployed inside the customer's own environment so clinical data never leaves their premises. The platform orchestrates specialized AI agents across four standards-native engines (SDTM, ADaM, Compliance, Statistics), enforces 21 CFR Part 11, HIPAA, and GDPR compliance with audit trails and e-signatures, and integrates human-in-the-loop review gates throughout. It targets Phase II/III sponsors and claims to reduce biometrics-to-reporting time by 30–50%. Astraea is a product of Astraea.
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