Tool overview
Astraea is listed under Healthcare AI tools.
What is Astraea?
Astraea is an AI-native clinical-trial platform that automates biometrics and submission workflows. It transforms protocols, raw study data, and metadata into CDISC-aligned datasets, statistical programs, tables, figures, listings, QC results, and FDA-ready packages.
Best for
Pharma sponsors and CROs automating regulated biometrics workflows
Who is it for?
Decision note
Suitable for evaluation after confirming final commercial terms, permissions, data handling, current product scope, and edit-screen aliases. Keep Needs Review enabled until a human verifies the published profile.
Key features
Protocol and raw-data ingestion
Automated SDTM and ADaM generation
TFL, Define-XML, and specification creation
QC and submission traceability
Deployment inside the customer environment
Use cases
Automate clinical-trial biometrics
Generate CDISC submission assets
Compress post-lock reporting timelines
Support oncology and rare-disease studies
Pros
- Covers the biometrics pipeline end to end
- Keeps clinical data inside customer systems
- Produces auditable human-review workflows
Cons
- Pricing requires an enterprise proposal
- Regulatory outputs still require expert validation
Limitations
Astraea accelerates biometrics execution but does not replace biostatisticians, clinical data managers, regulatory professionals, validation teams, or sponsor accountability. Every dataset, program, QC result, and submission artifact requires qualified review and controlled validation.
Pricing details
Billing options
Custom clinical-development agreement
Pricing note
The official product routes buyers to a sales, demo, or commercial discussion and does not publish a stable self-service amount. Pricing Model and Starting Price are Contact sales. A demo, pilot, or proof of concept is not recorded as a Free Trial, and no ongoing Free Plan is advertised.
Supported languages
- English
Integrations
Clinical trial protocols
Raw study data
CDISC standards
SDTM
ADaM
Define-XML
Pinnacle 21
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