elsai Clinical Protocol Audit Agent

elsai's Clinical Protocol Audit Agent is designed to ensure robust alignment across critical clinical trial documents. Key features include: • Cross-document validation for protocols, consent forms, and recruitment materials • Automated discrepancy detection • Comprehensive amendment and version tracking • Governance and audit traceability for review processes • Generation of IRB-ready review summaries This platform eliminates the labor-intensive task of manual line-by-line comparisons across lengthy and complex documents, significantly reducing the risk of compliance issues. It swiftly identifies inconsistencies in critical details like age ranges, study schedules, potential risks, and compensation, preventing costly rework from IRB feedback. The system links every document version to its relevant protocol or amendment, ensuring that only current and accurate materials are in circulation. The Clinical Protocol Audit Agent streamlines the entire review process from document upload to report generation. It extracts essential study details, verifies consistency across materials, and provides quick, side-by-side summaries of differences for efficient corrections. This ensures that all documents meet governance standards and are ready for submission or audit, enhancing compliance and accelerating trial timelines. Built for clinical and regulatory teams, quality assurance professionals, and medical writers, this agent integrates seamlessly with existing CTMS, eIRB, eTMF, Word, and Google Docs workflows. It empowers teams to maintain control over changes and approvals while providing a foundation for faster, more accurate document reviews, ultimately safeguarding clinical trials.