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Risks Module


About the module

  • Manage your inventory of Risks (safety concerns)  in one place, from registration, risk categorization, risk management strategies, related minimization measures, including local RMMs - and other activities​

  • Built around a powerful workflow engine that allows for the creation, review and approval of risk management documents​

  • Utilize MedDRA queries collections that are standardized across modules, to ensure that terms and medical concepts are assigned, reviewed and maintained against the risk ​

  • Auto-generate core RMPs, local RMPs / REMS using formatted core and local Word templates with the capability to introduce controlled “Snippets” for non-core template text​

  • Monitor timeliness across all deliverables using built-in charts, including a Gantt overview of risk commitment activities​

  • Links with Signal modules for fully integrated signal & risk process​

  • Use in collaboration with Requirements Intelligence to ensure that risk management activities are in alignment with global regulatory requirements

  • Maintains an audit trail for all changes and updates

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


Use SMQs or your own MedDRA Query collections to ensure the risk is accurately defined.

*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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