Summary

6+ year relationship with a large biopharma company that needed to change the operating model for their investigator-initiated trials (IIT), in part because of a merger. PRA’s Strategic Solutions Division (SSD) established an Embedded Solutions™ IIT program management structure leading to a seamless, quality-based operating model. This included creating and updating process flows, the supported research operations manual, and governance and relationship management plans.

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IIT Program Management Case Study

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