|Gerald F. Dunaway, PhD, MBA
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.
D. Dunaway, BS, MBA
Sr. Vice President
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
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
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 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.