Standards & Submission Automation
SDTM, ADaM, Define-XML, and TLF automation.
From CRF annotation to SDTM, ADaM, Define-XML, and TLF generation, three clicks from raw study data to submission-ready package.
The Astraea Advantage
Automation that regulators can inspect.
Astraea orchestrates specialized AI agents across the biometrics lifecycle, executing complex tasks in minutes rather than weeks, with 100% CDISC-aligned outputs and full audit-ready traceability. Outputs are reviewed by humans; the system records every step.
The pipeline
From raw data to reviewed outputs.
Raw Ingestion
Clinical data enters the pipeline from disparate sources. The ingestion layer normalizes formats and validates integrity before downstream processing.
CDASH Mapping
Raw clinical data is mapped to CDISC CDASH standards. AI-verified completeness checks eliminate weeks of manual annotation.
SDTM Generation
CDASH data is transformed into SDTM submission-ready datasets. Define.xml, reviewer guides, and validation reports generated with full traceability.
ADaM Transformation
SDTM datasets transformed into analysis-ready ADaM datasets. Derivation logic, population flags, and BDS/ADSL generation with automated QC.
TLF Production
Analysis datasets feed into automated Tables, Listings, and Figures generation. Submission-ready TLFs with version control and audit trails.
Data refinement · Standards generation · Statistical execution · Cross-track validation · Report automation · Full traceability
Key Capabilities
What we automate across your study.
aCRF Annotation
CDISC-compliant annotated CRF preparation aligned with your protocol and downstream SDTM targets, generated from metadata, reviewed by your team.
SDTM Mapping
Raw study data transformed into SDTM domains with full variable-level lineage. Astraea handles the mechanical mapping so your programmers focus on the edge cases.
ADaM Dataset Generation
Analysis datasets built to match the SAP, with ADaM-compliant structure, traceability metadata, and reviewer-ready derivations.
Define-XML & eCRT
Submission metadata and electronic case report tabulation packages generated automatically, aligned with current FDA submission requirements.
Statistical Programming
One-click TLF generation from the SAP, integrating SDTM/ADaM datasets with validated output packages ready for QC.
Pinnacle 21 Validation
Automated conformance checks against CDISC rules. Issues flagged inline, routed to the right reviewer, tracked to resolution.
Why Sponsors Choose Astraea
Built for the workflow regulators inspect.
Standards-Native Execution
CDISC SDTM, ADaM, and Define-XML are not bolt-ons. They are the substrate of the platform, aligned with FDA's position on study data standards.
Faster Without Shortcuts
30–50% productivity lift in the workflows Astraea automates, based on external benchmarks for biometrics and CSR drafting.
Human Approval, Always
Statisticians, programmers, and medical writers stay in the loop. Every material step is checkpointed for review, with CDISC validation and traceability.
Reduced Amendment Risk
Structured metadata and simulation help prevent late-stage rework, avoiding median amendment costs of $141K (Phase II) and $535K (Phase III).
Impact That Matters
The numbers behind standards automation.
Benchmark-grounded estimates based on published industry data, actual results depend on data readiness and review behavior.
Reporting cycle reduction
McKinsey: agentic AI could raise clinical-development productivity by 35–45% over the next five years.
Off post-lock reporting
Applied to a 40–60 business-day CSR cycle (AMWA / PharPoint benchmarks).
Annual capacity freed
Per lean three-role biometrics/writing pod, at BLS 2024 wage floor.
CDISC-aligned outputs
SDTM, ADaM, Define-XML, and aCRF artifacts that meet submission requirements.
Ready to automate your standards workflow?
Book a working session and we'll walk through Astraea on your actual SAP, protocol, and data.