The Astraea Platform
A standards-native execution layer for modern clinical development.
Astraea is our proprietary agentic AI platform, purpose-built to orchestrate biometrics, compliance, and submission workflows across the full clinical trial lifecycle.
Unified Control Plane
Automated data orchestration.
Track every stage of your clinical data workflow from a single interface, from protocol and SAP through SDTM, ADaM, TLFs, Define-XML, and CSR drafts. Everything stays visible, versioned, and reviewable.
Why It Matters
Compliant acceleration, not just speed.
Astraea is aligned with FDA's human-centric, risk-based, standards-based AI posture, so every efficiency lands with audit-ready traceability intact.
Compress the biometrics-to-reporting window in the workflows Astraea automates.
Outputs checked against CDISC conventions and statistical standards.
SDTM, ADaM, Define-XML, and aCRF artifacts that meet FDA submission requirements.
Tufts reports mean amendment implementation at 260 days, Astraea's structured metadata helps avoid the rework.
Four Engines
Four core engines. One controlled system.
Modular agents coordinate across standards mapping, compliance, evidence synthesis, and statistical execution, with human approval baked into every step.
Astraea Standards
Automated SDTM, ADaM, Define-XML, and aCRF generation. CDISC-native mapping with Pinnacle 21 validation baked in.
Astraea Compliance
Governed execution, data desensitization, and audit trails aligned with HIPAA, GDPR, 21 CFR Part 11, and FDA guidance.
Astraea Evidence
Extracts and synthesizes evidence from protocols, SAPs, CSRs, and literature to support clinical and regulatory decisions.
Astraea Stats
SAP-driven TLF generation with full traceability, validated statistical outputs wired into submission-ready packages.
The Platform in Action
Built for speed, designed for compliance.
01, Protocol Design
Human oversight for data analysis at AI speed.
Reduce data analysis and QC time by up to 90% while keeping experts in control of every critical decision. Reviewers see what Astraea did, why, and what to approve next.
02, Data Management
Unified visibility across the clinical data stack.
View, organize, and manage data across multiple sources, formats, and study assets in one workspace, with full lineage from raw capture through submission-ready outputs.
03, Analysis & Reporting
Automated SDTM and ADaM analysis with expert review built in.
Move faster on clinical analysis and downstream outputs with automation that improves speed, consistency, and traceability, without cutting the biostatistician out of the loop.
Core Capabilities
What Astraea's agents actually do.
Each capability is controlled, reviewed, and wired into a standards-native workflow.
SDTM & ADaM Mapping
Standards-native transformations from raw study data to submission-ready datasets, with full lineage.
aCRF Annotation
CDISC-compliant annotated CRFs generated from protocol artifacts and metadata.
Define-XML & eCRT
Structured metadata and electronic case report tabulation packages for FDA submission.
TLF Generation from SAP
Tables, listings, and figures programmed directly against the Statistical Analysis Plan.
Pinnacle 21 Validation
Automatic conformance checks against CDISC rules, issues flagged for human review.
Data Desensitization
HIPAA- and GDPR-aligned anonymization that preserves analytical utility.
Evidence Synthesis
Protocol-aware extraction from SAPs, CSRs, literature, and regulatory filings.
Governed Orchestration
Controlled AI workflows with role-based access, versioning, and approval gates.
Audit-Ready Logs
Full action history, who ran what, when, and on which dataset, 21 CFR Part 11 aligned.
Why Astraea
Not a writer. Not a dashboard. Not a CDMS.
Astraea is the bridge between protocol intent and regulator-ready evidence, the layer most of the clinical AI market leaves out.
Standards-Native Architecture
Built around CDISC SDTM, ADaM, and Define-XML from day one, not bolted on afterward. Matches FDA's stated preferences for study data submissions.
Human-in-the-Loop by Design
Every workflow exposes checkpoints for biostatisticians, programmers, and medical writers. Astraea augments experts; it does not replace them.
Executable, Not Just Advisory
Astraea doesn't only generate text. It runs statistical programming, produces validated TLFs, and emits regulator-ready submission artifacts.
Auditable at Every Step
21 CFR Part 11-aligned audit trails, versioning, and traceability, so compliance is a property of the system, not an afterthought.
Astraea makes agentic AI practical inside regulated biometrics, accelerating cycle times without compromising traceability or compliance.
See Astraea in action.
Book a working session with our team, we'll walk through how Astraea fits your SAP, standards, and submission workflow.