Managing a capital project is not for the faint of heart. Navigating the complex web of planning and execution requires an understanding of many aspects in the project delivery lifecycle. One key approach for PMs is to focus on achieving operational readiness once the project is complete.
Outsourcing of clinical trials is frequently done by pharmaceutical companies because they don’t have the expertise to run those trials, they need to expedite the timelines, or they are working at capacity. In this article, we explore key outsourcing activities for Phase I clinical trials from a PMBOK® Guide lens to identify key success factors.
An emphasis on well-controlled clinical trial programs and increased regulatory pressure for more meaningful, clinical data means that medical device companies must develop strategies to expand their capabilities for carrying out clinical trials.