PROJECT DELIVERY AND PROCESS IMPROVEMENT FOR RAVE SAFETY GATEWAY

Client Challenge

The existing data entry and review process for adverse events (AE) involved manual data retrieval and re-entry across systems and was not scalable for an expected increase in AE due to the initiation of new clinical trials. The client requested a Project Management and Informatics Subject Matter Expert (SME) to drive the integration of an Oracle Argus safety system with a clinical trial Electronic Data Capture system.

Red Nucleus Solution

The Red Nucleus Informatics SME engaged with a cross-functional, multi-region client team and multiple vendor teams on project planning and timeline management activities, facilitated regional and global business workshops, and supported validation activities and deliverables. The Informatics SME provided domain expertise to identify process efficiencies to be leveraged in the integrated system.

Value

The client successfully completed the integration project according to internal change management procedures and delivered an automated safety case entry process expected to facilitate significant reductions in case processing times.