Submissions Module
About the module
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Submit ICSRs to Authorities and other stakeholders seamlessly and via either automatic or manual workflows, as per reporting destination capabilities
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Manage compliance of all submissions via submission records. Manual submissions are managed in separate workflow, but compliance can be viewed, e.g. across all ICSRs, device reports, PSURs etc.
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Integrates with AS2 gateway, emails and “burn-links” for secure transmission
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Auto-detects late submissions and enforces a LTI form (Late Task Investigation) to ensure a compliant way of managing deviations
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Link to requirements, use requirements to schedule activities and reversely i.e. track the number of actual submissions sent out based on requirements
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The Submissions overview screen allows for setting search parameters and filter for charting, tables and details for submissions to specific reporting destinations or per destination type e.g. Ethics Committees
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Integrates seamlessly with the ICSR (Safety Database) module or connect via API with Argus Safety, ArisG and Veeva Vault Safety, to allow for automatic creation of submission records in HALOPV.
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
-The Submissions overview screen is fast and provides excellent overview of submission compliance across destinations. Set your own period for display and use the range of parameters to get the exact data needed.
*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 hello@insife.com.
We look forward to working with you.