https://doi.org/10.33015/dominican.edu/2018.bio.09">

Enter Digital Object Identifier:

https://doi.org/10.33015/dominican.edu/2018.bio.09

Graduation Date

8-2018

Document Type

Master's Thesis

Degree Name

Master of Science

Department or Program

Biological Sciences

Department or Program Chair

Meredith Protas, PhD

First Reader

Kathryn Davidson, MA, MS

Second Reader

Maggie Louie, PhD

Abstract

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 be facilitated by a clinical development Project Management Office (PMO) at pharmaceutical companies. Clinical development PMOs provide value by establishing processes that can be universally adopted by the pharmaceutical industry. This can help simplify product development, and as a result, accelerate time to market. Clinical development project management is a relatively new field in the pharmaceutical industry, and there are few publications and literary reviews regarding standardized best practices, current best practices, and potential best practices for clinical development.

Decreasing the time it takes a drug to reach market can help patients live longer and/or improve their quality of life. Time to market is often driven by the time it takes to test the product in clinical settings. This thesis is focused on analyzing the clinical development project management practices in order to reduce the time to market. The goals of this project were to identify best practices in clinical development project management, compile a reference standard, develop a rubric, evaluate the rubric on a comparator company, and make a recommendation regarding actions required for the comparator company to achieve the reference standard.

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