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Standards & Submission Automation
A solution automating CRF annotation, SDTM/ADaM mapping, Define-XML, and TLF generation, aiming for 100% CDISC-aligned outputs with Pinnacle 21 validation.
What is Standards & Submission Automation?
A solution automating CRF annotation, SDTM/ADaM mapping, Define-XML, and TLF generation, aiming for 100% CDISC-aligned outputs with Pinnacle 21 validation.
Product typeRegulatory Compliance
Pricing ·
Deployment
APINot available
What teams use Standards & Submission Automation for
Automating SDTM and ADaM dataset generation
Generating submission-ready TLFs from Statistical Analysis Plans
Automating CRF annotation and Define-XML creation
Providing audit-ready traceability for clinical data workflows
Accelerating biometrics-to-reporting cycles
Integrations and access
Platforms, integrations, and language support vary by plan and region. Confirm final requirements with the vendor.
Platforms
IntegrationsAPI and webhooks
Languages
Support
What reviewers say
Community reviewsReviews are owned and editable by their authors.
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Enterprise readiness
Compliance claims are normalized from current vendor documentation and independently reviewed by SOTA2.
Data retention:
Benchmarks and comparisons
Independent benchmarksStructured task results are being verified.
Side-by-side comparisonsComparison workspaces will be available in a later release.
