
Astraea is an agentic AI platform that automates clinical-trial biometrics and regulatory submission deliverables for pharma sponsors.
Astraea's platform orchestrates specialized AI agents across the biometrics lifecycle. It automates SDTM and ADaM dataset generation, Define-XML metadata, annotated CRFs, statistical programs, tables/listings/figures, and Pinnacle 21 conformance checks in one controlled system.
The platform is deployed inside the sponsor's validated environment so trial data and PHI remain within the customer's security boundary, and every action is logged, versioned, and reviewable for audit readiness.
Clinical-trial biometrics remains a large manual bottleneck for pharmaceutical and biotech sponsors, with Phase II/III studies requiring months of statistical programming, data management, and QC across fragmented tools. The cost and delay of manual biometrics work directly affect how quickly new drugs reach patients.
Regulatory pressure to produce CDISC-compliant, submission-ready outputs creates durable demand for automation that preserves traceability and audit readiness, positioning standards-native agentic platforms as a structural opportunity in clinical development.
Astraea's core advantage is a standards-native architecture built around CDISC SDTM, ADaM, and Define-XML from the ground up, rather than bolting standards onto a general-purpose system. Human-in-the-loop checkpoints keep biostatisticians and programmers in control of every material decision.
By deploying inside the sponsor's validated environment, the platform keeps sensitive trial data within the customer's security boundary while compressing biometrics-to-reporting cycles, addressing both speed and compliance requirements that generic automation tools cannot meet.