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Gerald F. Dunaway, PhD, MBA
President & CEO

Gerry Dunaway founded AmeriTrial OTC Research, Inc. in 1994 following a 34-year career in marketing and research with the Procter & Gamble Company.  He has over 25 years experience in clinical development and clinical trials with focused experience in Rx-to-OTC Switch Trials and Actual Use Studies.

Under his leadership, AmeriTrial has pioneered in developing innovative approaches in designing and conducting OTC trials and created new standards of quality and cost control in planning and conducting Phase III-IV clinical trials.  His relentless drive to find a 'better way' has produced an innovative CRO that provides services of superior quality and cost effectiveness in planning and conducting clinical trials.

He holds a doctorate and MBA degrees from the George Washington University and is a former member of the graduate division adjunct faculty at Johns Hopkins University.

Jeffrey D. Dunaway, BS, MBA
Sr. Vice President & COO

Jeff Dunaway has 22 years experience in clinical research, finance and business development in the financial services and pharmaceutical industries.  He has 6 years direct experience in the CRO industry, in planning and conducting large scale OTC trials and Phase III-IV clinical trials.  His skills and experiences are concentrated in the areas of trial planning and design; investigator selection and site development; site personnel training; trial management; and contracts and budgeting.

Jeff holds a BS degree from Towson University and a masters degree from Johns Hopkins University.  He is a member of the graduate division adjunct faculty at Johns Hopkins University.

Michael S. Epstein, MD, FACG
Vice President, Medical Director

Mike Epstein, MD is Vice President and Director of Medical Affairs.  Dr. Epstein received a doctor of medicine degree from Robert Wood Johnson School of Medicine, New Jersey College of Medicine.  He is board certified in internal medicine and gastroenterology.

Dr. Epstein has over 25 years continuous experience in clinical development and clinical research.  He has been a Clinical Investigator; Clinical Director; Vice President of Clinical Development and Vice President Clinical and Medical Affairs.  He has in-depth experience in the design and implementation of Rx-to-OTC switch trials as well as Phase III-IV trials.

Dr. Epstein is a member of the FDA Gastrointestinal Drugs Advisory Committee.  He is also Assistant Professor of Medicine, Uniformed Services of Health Sciences, Bethesda, Maryland.  Additionally, Dr. Epstein has authored a number of articles on clinical research concepts and issues.

Cindy Klug
Director, Regulatory & Administration

Cindy Klug has 13 years experience in the contract research industry.  For the past 10 years, she has been directly involved in the design and management of major Rx-to-OTC switch trials and complex Phase III-IV clinical trials.  Her responsibilities include planning, development and approval of regulatory elements of the trial design.  She also works with site management to insure regulatory compliance at each site throughout the trial.

Cindy has 9 years experience in managing regulatory compliance across a broad spectrum of OTC and Phase III-IV trials.  This experience includes complex OTC trials designed to measure and document consumer behavior.

Janice James, RN, NP, MS
Director, Monitoring & Quality Assurance

Janice James has 20+ years of clinical trial experience in monitoring; quality assurance auditing, project management and director of site monitoring and quality assurance.

As Director of Monitoring and Quality Assurance, Janice has responsibility for developing the monitoring plan, training site monitors, reviewing and approving monitoring reports, managing the monitoring plan, conducting monitoring audits and supervising quality assurance audits.  Janice represents AmeriTrial with the sponsor in all monitoring issues.

Janice received a Bachelor of Science degree in nursing from Radford University; a Master of Science degree in nursing from The University of Maryland and a Master of Science with a Nurse Practitioner specialty from the Johns Hopkins University.

 

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