Our comprehensive project methodology and governance structure strengthened our client’s compliance with increased regulatory oversight.
The Situation
As a result of increasing regulatory oversight on the topic of drug safety, pharmaceutical companies had begun focusing attention on proactive risk management initiatives. Our client had identified various compliance-related issues and enlisted our deep industry expertise to help remediate these areas of potential risk.
The Satori Solution
In conjunction with an alliance partner specializing in drug safety, we built and implemented a retrospective analysis project methodology which included the establishment of a governance structure and provision of full-scale project management resources. Our project task force created a methodology and action plan for analyzing and correcting outdated practices, developed the framework for conducting retrospective analyses, devised and tracked initiative success metrics, and deployed recommended solutions on an enterprise-wide basis.
The Results
Our comprehensive methodology, based in industry best practices, helped our client mitigate future procedural risks and establish operational excellence throughout all project life cycles.