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ICSRs Module


About the module

  • Intake ICSR information in structured forms or unstructured text from affiliates, partners/contractors – or even directly from consumers​

  • Works for clinical, post-marketed and solicited sources

  • As a Safety Database, perform case processing in HALOPV including all relevant fields for global compliance across EMA GVP Module VI / FDA / Health Canada / MHRA / NMPA / MFDS requirements, including advanced auto-coding / assessments – or integrate and transfer from your previous/existing Safety Database, .e.g. Argus Safety or ARISg

  • Use AI translation for e.g. narrative transformation to and from local language​

  • Integrates to the Submissions module, to auto-generate a number of formats including E2B(R3), E2B(R2) including Combination product reporting. ​This also allows for tracking the number of actual ICSR reports sent out based on requirements (auto-scheduling available if Requirements Intelligence module is enabled).

  • Reconcile ICSRs from local, clinical etc. sources with the ICSR (Safety Database) module

  • Maintains an audit trail for all changes and updates

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


The screens are designed for optimal overview of the case as it is processed, across a workflow, including markings where mandatory data is required. 

*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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