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Clinical Studies Module


About the module

  • Setup a register of clinical studies and manage status

  • Link to Sites entities, to automatically identify investigators linked to relevant sites and initiates tasks for each investigator to e.g. pickup files such as SUSARs

  • Integration with external Safety database – Information is automatically transferred to HALOPV

  • Option of integrating with existing CTMS (Clinical Trial Management System) or run as independent system

  • Option to include other distributions for investigators such as training, contracts, etc.

  • Link to PSMF module, to populate Annex C/H or Study list

  • 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.

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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