Astraea

Astraea is clinical trial automation software for pharmaceutical sponsors that automates work after protocol design and raw data collection, including SAPs, eCRFs, TFLs, SDTM and ADaM datasets, Define-XML, QC, and FDA submission documents. It is installed inside the customer's own environment by forward-deployed engineers, so study data and PHI remain within the customer's security boundary.

The platform is organized around four engines: Astraea Standards (SDTM, ADaM, Define-XML, and aCRF generation with Pinnacle 21 validation), Astraea Compliance (governed execution, data desensitization, and audit trails), Astraea Evidence (extraction and synthesis from protocols, SAPs, CSRs, and literature), and Astraea Stats (SAP-driven TLF generation). Capabilities include CDISC mapping, aCRF annotation, Define-XML and eCRT packages, Pinnacle 21 validation, HIPAA- and GDPR-aligned data desensitization, evidence synthesis, governed orchestration with role-based access and approval gates, and 21 CFR Part 11-aligned audit logs. A unified control plane tracks workflow stages from protocol through CSR draft.

Astraea is aimed at pharmaceutical sponsors across therapeutic areas, including oncology and rare disease, as well as medical devices, and is offered alongside end-to-end biometrics services and an AI-augmented FSP model operated within the customer's SOPs and governance. It is not a CRO or a web-hosted service; pricing and packaging details are not stated.