Astraea is an AI-native clinical trial platform designed to transform the clinical development process by automating critical tasks from protocol design to FDA submission. Developed by a team of biostatisticians, clinical programmers, AI engineers, and industry veterans, Astraea integrates intelligent automation with scientific precision and regulatory compliance to accelerate the delivery of life-saving treatments.
Key Features and Functionality:
- Multi-Agent AI Architecture: Astraea employs specialized AI agents to automate various stages of the clinical trial lifecycle, including standards mapping, compliance, evidence synthesis, and statistical execution.
- Standards & Submission Automation: The platform automates the creation of SDTM, ADaM, Define-XML, and annotated CRFs, ensuring CDISC compliance and reducing manual effort.
- Compliance and Data Control: Built with compliance at its core, Astraea aligns with 21 CFR Part 11, HIPAA, GDPR, and FDA guidelines, providing audit-ready traceability and controlled execution.
- End-to-End Biometrics: From protocol design through NDA/BLA submission, Astraea offers full-service biostatistics and programming with inspection-ready deliverables.
- AI-Augmented Functional Service Provider (FSP): The platform can be operated within a sponsor's environment by Astraea's embedded experts, ensuring seamless integration with existing systems and governance.
Primary Value and Solutions for Users:
Astraea addresses common bottlenecks in clinical trials by reducing reporting cycles by 30–50%, delivering 100% CDISC-ready outputs, and cutting 12–30 days off post-lock timelines. By automating labor-intensive processes, Astraea enables faster submissions, higher success rates, and sustainable growth across clinical portfolios. Its deployment within the sponsor's environment ensures that sensitive data remains secure, as Astraea never stores or accesses clinical data. This combination of speed, compliance, and data control empowers clinical innovators to bring treatments to patients more efficiently and safely.
