Aggregate Reporting Module

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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.

Further details

HALOPV Aggregate Reports module is an easier and more flexible way to produce reports and track progress along the way. It is part of the set of Regulatory and Science modules

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

We are ready to provide your with further information, and can setup a demo for you, where we take you through a guided tour of the application. If you would like to take it a step further, we also have test environments for you to explore in detail. 

Write to sales@insife.com - we are looking forward to helping your organization!