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Case Study

Launching Pharmacovigilance Technology Projects

Summary

A rapidly growing global biotech firm needed to accomplish a portfolio of critical IT projects in their clinical development and regulatory organizations. These projects were necessary to support key future business capabilities and needed a plan of action.

Situation

A rapidly growing global biotech organization identified a portfolio of critical IT projects in their clinical development and regulatory organizations necessary to support key future business capabilities. Minimal resources existed to launch these projects, and the responsible business and IT teams were undergoing restructuring and not fully staffed. Our team was asked to launch and take ownership of important, nascent IT projects in Pharmacovigilance, Risk Management, and Pharmacoepidemiology and transition ownership to our client once the appropriate teams were ready.

Satori Solution

We employed a strategic and logical approach to launch the portfolio of projects. We worked with business and technology sponsors to refine the objectives, timeline, and priority level of each project. We then formed a project team and developed a project governance structure for each project. We scoped all phases of each project, and drove the execution of tasks. Projects ranged from finding and transitioning to a new application managed services provider to implementing advanced signal management tools for the Risk Management team.

Results

We successfully developed a strong foundation for each of the critical IT projects and effectively transitioned them to client teams over time. Each project met the timeline established by its sponsors and delivered the anticipated business impact. As a result of our work, the client was able to launch the first wave of projects on their IT roadmap despite having minimal resources devoted to this task.

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