Standards-Aware Clinical AI
Smarter, faster, safer clinical trials with agentic AI.
From protocol design to FDA submission, Astraea transforms clinical data workflows with multi-agent AI and automation, cutting cycle times, reducing costs, and ensuring compliance at every step.
30–50%
Faster biometrics cycles
- HIPAA Aligned
- CDISC Compliant
- 21 CFR Part 11
- GxP Ready
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 biostatisticians, programmers, or medical writers. It gives them a traceable, standards-native execution layer that collapses handoffs, reuses structured metadata, and produces regulator-ready outputs faster, under human supervision, with full auditability.
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 →Embedded Biostatistics Teams
Scalable FSP resourcing with AI-enhanced biostatisticians and programmers embedded in your SOPs, systems, and governance.
Learn more →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.
