Case Study

Project Delivery and Process Improvementfor RAVE Safety Gateway

Project Delivery and Process Improvementfor RAVE Safety Gateway

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www.rednucleus.com contact us at info@rednucleus.com Case Study R&D 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 gl

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