Subject Pre-Screening & Authentication
Clinilabs Drug Development Corporation phase 1 units are distinguished from other research facilities by virtue of established methods to pre-screen and authenticate subjects.
Our pre-screening protocol engages subjects in a large-scale database project. This project enables us to obtain medical history, height, weight, body mass index (BMI) and medication history, and perform routine tests such as a urine drug screen. This information is entered, with permission, into our subject database. Therefore, sponsors are assured that study candidates are pre-screened for eligibility in their studies, minimizing the rate of screen failures.
Subjects also go through a thorough subject authentication process in order to exclude individuals who may be screening at another location, enrolled in another study, or in a lockout period. We have taken steps to minimize the risk of “dual enrollers” and other individuals who may jeopardize study integrity. More than 11 percent of subjects in the U.S. provide false information to investigator sites in order to gain enrollment into a clinical trial or to avoid taxes on research subject stipends. Sponsors have the confidence that these subjects are excluded at Clinilabs research facilities.
Drugs don’t work in patients who don’t take them
– C. Everett Koop, MD