Full manual creation in target source

The client received an audit finding relating to the insufficient tracking of investigational and post-approval commitments. Although investigational and post approval commitments were previously out of scope for the RIM system dataset, ICON determined to increase the dataset scope within the RIM system to track commitments. The decision to bring both investigational and post-approval commitments into RIM meant large-scale changes across multiple system entities (product families, products, applications, events and tasks), changes to data dictionary values, creation of a validated report and the definition of new business processes were supported.

Working with multiple teams and the client, ICON defined a robust business process that met the needs for tracking commitments across INDs (investigational new drug applications), CTAs (clinical trial applications), NDAs (new drug applications), and MAAs (marketing authorization applications). ICON updated the master data definition documentation to align with the new dictionary values. ICON worked closely with the data owners before manually creating commitments based on information in excel trackers, created a communications plan and developed training materials for the Data Entry team and the end users before business process launch. ICON collaborated with the client’s senior management to build, validate and deploy a commitments report to fully support the overall changes.

ICON enhanced commitment compliance for the client and managed a smooth data transition from external commitment trackers to RIM. ICON worked quickly to understand the scale of the change and the impact it would have on existing system entities to rapidly define the business process that would support the data provision, Data Entry and verification requirements. Once the commitments had been created in RIM, and the data owners had carried out the necessary QCs to ensure the accuracy of the data, the external trackers were retired. This change had a very positive impact on the business as the client could now receive system alerts on their commitments, check due dates for the required action and quickly navigate to other areas of their regulatory data all in one system.