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ICSRs Module

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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

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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.

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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 hello@insife.com.

 

We look forward to working with you.

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