Karin has over 25 years of experience in clinical and health outcomes research, specializing in instrument development and validation, as well as design and management of research focused on clinical outcome assessment (COA). She has extensive experience in qualitative and quantitative methodologies and expertise in regulatory strategy regarding the inclusion of COA as primary or secondary endpoints in clinical trials. She has participated in preparing and defending successful FDA submissions of COAs. Karin received a Ph.D. from Johns Hopkins University, an MPH from San Diego State University, and a BSN from Xavier University.