Project

Evaluating Communication Channels and Practices Within and Across the Ardea Phase 3 Clinical Program

Ardea Biosciences, Inc., a wholly owned subsidiary of AstraZeneca, PLC., recently developed several gout drugs, with Lesinurad as the most advanced product candidate in Phase 3 clinical trials. A new organizational structure was implemented for executing the late phase clinical studies. In hopes of successful Federal Drug Administration approval of this new product, the new structure follows a chartering-based system, constructed to manage individual studies by cross-functional teams, assigning individuals to specific studies as their main focus. As the clinical program moves forward, communication efficiency becomes a key aspect in ensuring project consistency within and across the organization. The purpose of this Semester-In-Residency (SIR) project was to identify the information requirements needed by each functional group within and across study management team (SMT) members, along with additional layers of management. Using a qualitative approach, an initial survey questionnaire examined the clinical program’s organization at the core and extended level, identifying information requirements and barriers that prevent proper information sharing. The survey was administered to 30 people, and the results assisted in defining a standard process for project information sharing that is more efficient and effective for the organization. As a result, the survey responses were used to help design Project Central, a Microsoft SharePoint server, which was implemented as a seamless communication portal for all project information. An introduction of this platform was presented to all study management teams before its initial launch to the entire company. Project Central was developed as the technical solution for all current and future clinical projects, allowing all functional groups to access the information they need to successfully perform their jobs and bring about the desired outcome to the Phase 3 clinical projects.

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