Clincove today announced the launch of Protocol AI, a new capability within the Clincove platform that uses advanced language models to analyze clinical trial protocol documents and automatically generate study configurations — including visit schedules, CRF fields, edit checks, and data validation rules — in minutes instead of weeks.

From Months to Minutes

Study setup is one of the most time-consuming phases of any clinical trial. Traditional approaches require weeks of manual configuration: a clinical data manager reads through a protocol document, manually defines visit windows, creates case report forms, builds edit checks, and configures validation rules. This process typically takes 6-12 weeks and is prone to human error.

Protocol AI changes this entirely. Users upload a protocol PDF, and the system extracts the study design, identifies endpoints, maps visit schedules, and generates a complete draft study configuration — ready for review and refinement by the clinical team.

How It Works

  • Upload a protocol PDF — Protocol AI parses the document using specialized clinical trial language models
  • Review the generated study design — Visit schedules, assessments, and procedures are auto-mapped from protocol language
  • Refine CRF fields and edit checks — The system generates draft forms with appropriate field types, validation rules, and cross-form checks
  • Deploy to production — Once reviewed, the study configuration is live and ready for data capture

Early Results

In beta testing across 12 studies, Protocol AI reduced study setup time by an average of 83%, from 8 weeks to under 10 days. Clinical data managers reported spending their time on refinement and quality review rather than manual configuration.

Availability

Protocol AI is available immediately to all Clincove platform customers at no additional cost. It is accessible from the Study Setup module within the Clincove dashboard.

About Clincove

Clincove is the unified operational layer for clinical trials. Learn more at clincove.com.

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