Karin has over 25 years’ 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). Her therapeutic areas of expertise include cardiovascular, urology, gastrointestinal, diabetes, and women’s health. Karin 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 earned her PhD from Johns Hopkins University, an MPH from San Diego State University, and a BSN from Xavier University. She has authored over 130 publications which have appeared in Journal of Urology, European Urology, Circulation, Journal of American College of Cardiology, British Journal of Urology International, Journal of Sexual Medicine, Quality of Life Research, and Value in Health, among others.