Astraea
Astraea is an AI-native clinical trial automation platform that automates biometrics and FDA submission workloads—including SAP, SDTM/ADaM, TLFs, Define-XML, and QC—inside the sponsor's own environment.
Where Astraea ranks
Current edition · updated Oct 20, 2026About Astraea
Astraea automates clinical trial biometrics from raw study inputs to FDA-ready outputs. The platform handles data normalization, CDISC mapping, SDTM, ADaM, TFLs, QC, and revision workflows in one auditable system, helping Phase II/III sponsors reduce months of manual programming and data management into automated, reviewable execution.
Products
A proprietary agentic AI platform for biometrics, compliance, and submission workflows, featuring four engines: Standards, Compliance, Evidence, and Stats.
A solution automating CRF annotation, SDTM/ADaM mapping, Define-XML, and TLF generation, aiming for 100% CDISC-aligned outputs with Pinnacle 21 validation.
Full-service biostatistics and programming from protocol design through NDA/BLA/IND submissions, delivering inspection-ready results while operating inside the customer's valida...
A Functional Service Provider model where Astraea experts operate the platform inside the customer’s SOPs and governance, allowing sponsors to adopt the platform with zero deliv...
Security and compliance
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