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Aggregate Reporting Module


About the module

  • Maintain overview and produce various types of aggregate reporting from clinical to post-market – also locally - Built around a powerful workflow engine that will allow for the review, approval and management. Current out-of-the box reports:

    • DSUR Line Listing (blinded / unblinded)

    • DSUR Summary Tabulation (period/cumulative)

    • PBRER Summary Tabulation

    • SAE Line listing

    • PADER including device malfunctions

    • Reconciliation listing

    • PRR signal report (also available from Signal management)

  • Auto-generate documents, format using Word templates. Template based document creation but also with “text snippets” that allow controlled introduction of non-core template text

  • Monitor timeliness across all deliverables, and utilize built-in charts including Gantt overview of activities.

  • Link to Requirements Intelligence to ensure that reports are timely against regulations

  • Maintains an audit trail for all changes and updates

  • Is GxP validated* and ready to use in the cloud

*Validation package provided with documented proof of execution of test cases according to Insife’s standard process configuration. Additional validation activities may be needed to satisfy needs for your organization.

Want to know more, get a demo or take it for a test drive?

We would love to tell you more and answer any questions you have, take you through a demo or let you test the system so you can explore yourself. Just email


We look forward to working with you.

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