Automated conversion and load, including manual enrichment

ICON was asked to support a client with migrating data from an existing Regulatory
Information Management (RIM) system into a new system. During migration, the ICON team needed to ensure the safety reporting requirements were correctly described in the new system as current data were incorrect and/or incomplete.

Data were extracted from the existing RIM system, converted using automation to the new structure and format and then analysed for completeness and accuracy. Prior to migration, ICON checked that the pre-approved data in the existing system were correct, spot checked, and properly prepared for loading. Data that were not verified or products which did not have safety reporting requirements specified were checked against existing knowledge bases (e.g., EU EURD list for PSUR submission frequency, submission dates, data lock points, etc.). 

Data were enriched as much as possible within the internal team and then sent to the LOCs for review and verification. All verified data were automatically converted to data load spreadsheets and loaded to the new RIM system using the validated load tool. Data that were not verified promptly were not loaded but were handed over to the Data Entry team for continued analysis and completion post Go Live.

The number and accuracy of safety reporting events increased, and data were loaded
according to the new RIM system release schedule. The decision to load the best available information at the time of Go Live meant there were no delays, and instead, the information load was completed in a LOC-friendly timeframe.