Astraea Analysis
What is Astraea?
Astraea is an AI-native clinical trial platform that automates biometrics workflows from protocol design through FDA submission. Its system uses four modules for standards mapping, compliance, evidence synthesis, and statistical execution. The company says it serves biotech startups through top-10 global pharma and is backed by Y Combinator.
Location
San Francisco, United States
Employees
1-10
Founded
2026
Industry
B2B
AI Pattern
AI agent for a vertical
Blog Category
Health
Builds Hardware
Software only
Business Model v4
Biotech
Delivery Model
Services-as-software (AI-native service)
Sub-cluster
clinical trial automation
YC Partner
David Lieb
Product Description
Astraea offers a range of products and services designed to enhance the clinical trial lifecycle, focusing on automation and compliance. Their main offerings include:
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Standards & Submission Automation: This service automates the generation of Clinical Report Form (CRF) annotations, SDTM/ADaM mappings, Define-XML, and TLF generation. Users can create submission-ready packages with just three clicks, streamlining the submission process to regulatory bodies.
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End-to-End Biometrics: Astraea provides comprehensive biostatistics and programming services from protocol design through to NDA/BLA submission. This ensures that all deliverables are inspection-ready and compliant with FDA and EMA standards.
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Embedded Biostatistics Teams: This offering includes scalable Functional Service Provider (FSP) resources, integrating AI-enhanced biostatisticians and programmers into clients' standard operating procedures (SOPs), systems, and governance frameworks.
These services are designed to reduce cycle times, ensure regulatory compliance, and improve the overall efficiency of clinical trials, making them particularly beneficial for clinical research organizations and pharmaceutical companies managing multiple trials.
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