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Case Study

Leading Project Management for Pharmacovigilance Transformation


The pharmacovigilance (PV) organization of a leading pharmaceutical firm, seeking to improve operations and control costs in the face of significantly increased case volume, undertook a transformation initiative to integrate its global PV activities and increase operational efficiency. The initiative involved establishing regional hubs of fungible resource pools to manage peak case volumes across the globe. Our client engaged us to drive the idea to reality and help with the strategic design, implementation planning, and project management.

Satori Solution

We managed the planning and execution of the regional hub rollout, including establishing a governance structure for the overarching effort and tracking progress. We also designed an operating model which established a centralized hub for clinical trial case processing. This included exploring ways to drive cost avoidance/savings and process efficiency in case processing practices, identifying potential savings of $2.4M. We helped the client create a business case which received buy-in from the senior management team.


We actively managed resistance to change and completed the on-time implementation of the case processing regional hubs. Additionally, the business case we developed helped generate essential senior management support.



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