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.
HALOPV Clinical Studies module is bridging critical information from clinical to operate PV effectively. It is part of the "base" modules that are always provided for our customers in any HALOPV deployment
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.
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