Background

Pharmacovigilance is a versatile industry where there is a constant, ever growing need to identify the key areas of compliance and make sure that team is well-aware and trained to achieve core compliance. Diverse Clients of Sarjen’s PV solution also wanted to assure adherence to such areas; one of them being Submission tracking system. There were certain concerns to address for submission of reports and automate the process using a robust system.

Client’s Concerns

The Clients had mainly following Submission concerns:

• Needed a submission system where different submissions are tracked
• Needed a system to update users on eligible countries for submission
• Needed a system to submit ICSR reports in different regions as well as to EVHUMAN
• Wanted to upload submission dates and Acknowledgement files at once for multiple submissions

Sarjen’s Challenge

Overall, Clients had an expectation of a flexible yet user convenient submissions management system to allow for tracking, reporting and managing submission files.

• Complying to different submission conventions of various companies
• EVHUMAN submissions and minimalizing data entry effort of Submission user
• Tracking individual case wise countries where submission is due instead of country wise case submissions

Our approach to flexible Submission Management ‘System’

• Allowing different project product details (Marketing authorization) selection while submitting ICSRs
• Option to select appropriate project details based on either Submission country, AE origin country or Source country to suit client’s submission conventions
• Allow submission to all/multiple EVHUMAN countries, have submission details uploaded just once; thus saving time and user effort
• Submission compliance ensured for atypical scenarios faced by end-users
• Customized submission rules configured in system where user is alerted of ICSR reportability criteria immediately once case is created in system
• Each user workflow can expedite case(s) as countries where case is eligible for submission is accessible
• Submission rules can be updated from time to time for continued compliance
• Submission compliance report to track for all submissions including delayed submissions, if any!
• Automates versioning & other info. based on previous submissions to each of the applicable countries
• Ignored submission reports can be checked within case/ADR lifecycle for user reference and action
• Generate already submitted reports (CIOMS, XML, VAERS etc.) for sharing, review, archival etc.