Charles H Pierce, MD, PhD, FCP (Fellow of the American College of Clinical Pharmacology), CPI (Certified Physician Investigator) is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of the GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce serves as an advisor to several clinical research organizations, sits on University and industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been active in the Clinical Research Industry for 19 years including 7 years as the PI of a large CRO, has authored a "Manual for Investigators", and has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.