Compliant Case Exchange and Automated Reconciliation
A sponsor may have a multiple SDEA with different partners for exchange of safety data for the licensed products. As per these SDEA a sponsor or a partner is responsible for exchange of data in agreed timelines. The data exchanged needs to be further assessed and qualified for ICSR and further submission to regulatory agencies in defined timelines. It is Sponsors or Partners responsibility to further track and share the safety data to different Partners as per SDEA executed.
Additionally, the Sponsor or Partner is responsible for Reconciliation of Safety Data Exchanged to ensure there are no missing Adverse Events which are not shared as per SDEA. Reconciliation is a critical process and time consuming when there are multiple SDEA executed.