Pre-qualified volunteers receive a detailed explanation of the study requirements and known potential risks. Volunteers' questions are answered, and they are asked to sign the institutional review board (IRB) approved study-specific informed consent form. Study volunteers are qualified for trial participation by the principal investigator based on a review of the subject's medical history and the results of a thorough physical exam and required diagnostic tests.
Special Volunteer Populations
PPD’s Phase I clinic is able to support special volunteer population study requirements including elderly, post-menopausal, poor and extensive metabolizers, obese and smokers.
PPD’s Phase I network of patient sites supports patient population studies including but not limited to renal, hepatic, diabetic, neuroscience and abuse liability.