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Clinical Study Reports (CSR) Automation

Regulatory compliance · by Ritivel

Automates CSR drafting from Protocol and Statistical Analysis Plan inputs, generating non-data sections, biostatistical Tables Listings and Figures, and data-centric sections with word-level traceability.

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What it does

Automates CSR drafting from Protocol and Statistical Analysis Plan inputs, generating non-data sections, biostatistical Tables Listings and Figures, and data-centric sections with word-level traceability.

  • Clinical Study Report automation
  • Common Technical Document submission
  • Regulatory guideline search and interpretation
  • Internal regulatory document search
Category
Regulatory compliance
Built for
Healthcare and life sciences
Users
Pharma, Biotech, Medtech, CROs and 2 more
Public API
Not offered
Deployment
Self-hosted, On-premises

Not yet disclosed: platforms, languages and support channels.

Pricing

  • Free plan$0

Free trial on paid plans

Prices as published by Ritivel, checked Oct 2026.

Security and compliance

As reported by Ritivel. Ask for audit reports before you buy.

  • 256-bit encryption for data at rest and in transit
  • Zero data retention
  • No model training on customer data
  • 100% local deployment
  • Air-gapped ready
  • Audit logging
  • Role-based access control
  • IP allowlisting
  • Word-level traceability
  • Deterministic outputs

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