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Standards & Submission Automation

Regulatory compliance · by Astraea

A solution automating CRF annotation, SDTM/ADaM mapping, Define-XML, and TLF generation, aiming for 100% CDISC-aligned outputs with Pinnacle 21 validation.

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What it does

A solution automating CRF annotation, SDTM/ADaM mapping, Define-XML, and TLF generation, aiming for 100% CDISC-aligned outputs with Pinnacle 21 validation.

  • 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
Category
Regulatory compliance
Built for
Healthcare and life sciences
Users
Pharmaceutical sponsors, Biotech companies, CROs, Clinical research teams
Public API
Not offered

Not yet disclosed: deployment options, platforms, languages and support channels.

Pricing

Pricing isn't published

Astraea doesn't list prices publicly. Ask them for a quote.

Security and compliance

No security details published yet

Astraea hasn't published certifications or security practices for Standards & Submission Automation that we could find. Ask their team for audit reports.

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