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Best Practices In A Clinical Development Project Management Office (Pmo) To Achieve A Reference Standard In The Pharmaceutical Industry, Russell Guinto

Dissertations, Masters Theses, Capstones, and Culminating Projects

Medications are developed by the pharmaceutical industry starting with the discovery phase, proceeds to preclinical trials, moves into clinical trials (progressing from Phase I to Phase III), and if the data are positive, may lead to Food and Drug Administration (FDA) approval. Once approved, post-marketing surveillance for safety is required as long as the drug is marketed to consumers. This phase may also include clinical trial Phase IV studies if additional safety testing is required. This process usually takes between ten to fifteen years, with clinical development taking seven to ten years of that time (1). Clinical development can …