Clinical, Statistical and Regulatory ConsultantKaren Bannick, MA, FRAPS, RAC is a Clinical, Statistical and Regulatory Consultant for DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She focuses on regulatory strategy development and execution, submission preparation, clinical design and reporting, and professional medical writing. Karen has a twenty-eight year career working in FDA regulated industries.
Ms. Karen Bannick began in clinical and regulatory affairs working as a biostatistician and data base analyst at the University of Minnesota, and then Medtronic. While at Medtronic, she expanded into global regulatory affairs, working with cardiovascular 510(k)s, PMAs and IDEs as well as EU and other international submissions. She founded her consulting company in 1998 and has continued to provide clinical, regulatory and statistical guidance to small and large medical device companies. Her experience includes products in many disciplines: cardiovascular, neuromodulation, incontinence, wound care, chronic pain, and sleep apnea.
She brings extensive regulatory experience with global regulatory organizations, fostering consensus and generating cooperation from multicultural, multidisciplinary teams. As a biostatistician, she is often able to offer added insights into potential clinical and regulatory strategies and analysis plans. Karen has prepared numerous submissions (including 510(k)s, PMAs, IDEs, and Tech Files) and clinical reports (including CSRs, manuscripts and CERs).
She has a BA in biostatistics and computer science from the University of Minnesota and a Master’s in Health and Human Services and a Master’s in Management from St. Mary’s University. She is a RAPS Fellow and President of the North Central American Medical Writers Association (AMWA) Chapter.