trialwiseSCAN & Quality

trialwiseSCAN is a 21 CFR part 11 compliant, validated mobile document scanning application that delivers on-device indexing and direct eTMF transfer to maximize operational efficiency and enhance TMF quality.


  • Improve TMF Contemporaneity
    Streamline the flow of high quality documents into your eTMF.

  • Improve TMF Completeness
    Reduce the risk of lost and misfiled documents with robust, validated processes that drive correctly indexed documents to the appropriate location in your eTMF.

  • Deliver Improved TMF Quality
    Take your TMF quality to the next level and stay inspection ready with improved contemporaneity, completeness and clarity.


  • 21 CFR part 11 compliant
    Meet compliance obligations for robust, validated processes. See our 21 CFR Part 11 Compliance Checklist for details of the controls used to maintain compliance.

  • Internally validated
    trialwiseSCAN is internally validated for reliability, consistency and accuracy against established requirements. Refer to our whitepaper for details.

  • Archive ready PDF/A
    Deliver PDFs that conform to ISO 19005 standard PDF-A-1b, the recommended standard for long term, reliable reproduction of document visual appearance. See our PDF/A whitepaper for details.

  • Automate filename generation
    Promote consistency and minimize manual re-entry and errors, by enabling the rapid application of structured filenames at an early stage in the document life cycle.

  • Control indexing standards & metadata
    Implement indexing standards and deploy site level metadata according to study specific TMF requirements. See our whitepaper on file indexing for details.

  • Granular level controls
    Manage sponsor and study specific requirements through configurable controls for image capture, indexing and file naming standards and metadata.