ICSRs Module


About the module

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

  • Manage case processing in HALOPV including coding / assessments – or integrate and transfer from the 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 safety database

  • 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

From Case Intake to Follow-up Management, HALOPV takes the hard work out of managing the ICSR process. It is part of the set of Case processing 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!