Astraea Overview

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What Astraea Does

Astraea is an AI‑native clinical trial platform designed to automate and accelerate clinical biometrics workflows. It orchestrates specialized AI agents to perform tasks across the lifecycle of clinical development, from protocol design through regulatory submission.

The platform focuses on workflows that regulators actually inspect. Each automated step is traceable, reviewable, and designed to produce submission‑ready outputs aligned with established industry standards.

Astraea combines automation, standards awareness, and human oversight to help teams reduce cycle times while maintaining auditability and compliance.

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Key Outcomes

Organizations using Astraea aim to:

• Accelerate biometrics cycles
• Produce standards‑aligned deliverables
• Maintain traceability across workflows
• Generate regulator‑ready outputs

The platform is designed to support faster reporting cycles while keeping workflows transparent and reviewable.

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What Astraea Automates

Astraea focuses on biometrics and regulatory workflows commonly required during clinical development. These include:

• Clinical standards mapping
• Statistical execution
• Evidence synthesis
• Regulatory submission preparation

Outputs produced through these workflows can include SDTM, ADaM, Define‑XML assets, and reporting artifacts aligned with submission conventions.

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Human‑in‑the‑Loop Execution

Astraea does not replace biostatisticians, programmers, or medical writers. Instead, it provides a standards‑aware execution layer that supports these teams with automation and AI assistance.

Workflows remain governed and reviewable, allowing teams to supervise outputs while benefiting from accelerated production of deliverables.

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Where Astraea Fits in Clinical Development

Astraea is designed to support activities across the clinical trial lifecycle, including:

• Protocol design
• Statistical analysis planning
• Data standardization
• Reporting and regulatory preparation

By orchestrating AI agents across these steps, the platform helps teams move from protocol to submission with structured data, traceable processes, and validated outputs.