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Vice President, Global Biometrics
Ms. Fitzgerald is responsible for the global strategic, tactical, and operational performance of the Data Operations, Biostatistics, Medical Writing, and IVRS groups at Premier Research. For nearly 15 years, she has held high-responsibility positions in Biometrics, including project management and medical writing. During this time she managed over 300 biometrics projects and wrote more than 250 Phase 1–3 study reports following FDA/ICH guidelines. She has contributed to successful new drug submissions and publications in many therapeutic areas. Her work on accelerating the drug development process resulted in the co-authorship of "Getting Your Drug to Market Faster: From Database Lock to Final Report in Two Weeks". This accelerated process redefined the industry standard for Phase 2 and 3 clinical/statistical reports and is the backbone of the Premier Research Parallel Processing Approach™. Her understanding of the drug development process combined with her organizational and management strengths have proven to be an effective combination. Ms. Fitzgerald obtained an MS degree from Georgia Southern University and a bachelor's degree from Stetson University in Florida.
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