The Astraea Platform Engines

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Platform Overview

Astraea provides a unified platform that orchestrates specialized AI capabilities across clinical biometrics workflows. The system is organized around four standards‑native engines designed to support the full lifecycle of clinical data preparation and reporting.

Together, these engines form the execution layer that drives automation across protocol design, data preparation, statistical analysis, and regulatory deliverables.

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Astraea Standards

The Standards engine focuses on automated generation of key CDISC artifacts used in clinical submissions.

Capabilities include:

• SDTM generation
• ADaM generation
• Define‑XML creation
• Annotated CRF generation

Mappings are aligned with CDISC standards, and validation processes incorporate Pinnacle 21 checks to help ensure outputs conform to submission expectations.

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Astraea Compliance

The Compliance engine governs execution across workflows.

It supports:

• Controlled execution of automated processes
• Data desensitization
• Audit trails for workflow activities

The system is designed to align with regulatory and industry expectations such as HIPAA, GDPR, 21 CFR Part 11, and broader FDA guidance.

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Astraea Evidence

The Evidence engine extracts and synthesizes information from clinical and regulatory documents.

Sources can include:

• Protocols
• Statistical Analysis Plans (SAPs)
• Clinical Study Reports (CSRs)
• Scientific literature

This synthesis supports decision‑making and downstream regulatory documentation.

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Astraea Stats

The Stats engine focuses on statistical outputs driven by the Statistical Analysis Plan.

It generates TLFs (tables, listings, and figures) with traceability back to the analysis specifications.

These outputs are designed to integrate directly into submission‑ready reporting packages.