Clinical monitoring is a required element of all clinical trials. Monitoring is conducted to protect the rights and well-being of human subjects, to ensure that clinical trial data are accurate, complete, and verifiable, and to confirm that the conduct of trials is in compliance with Good Clinical Practices (GCPs).
Clinilabs Drug Development Corporation provides Clinical Research Associates (CRAs) for drug trials conducted in North America, the European Union, and Asia. Our monitoring teams typically are composed of “in-house” monitors, including a Lead Monitor, and regional contract monitors. We strategically hire and source monitors with more than 10 years of experience in order to provide sponsors with seasoned, professional teams with therapeutic area expertise. This is a core element of our business plan.
Clinilabs Drug Development Corporation medical monitors are experts in a variety of CNS therapeutic indications, providing 24/7 medical coverage on behalf of the sponsor. Medical monitors help investigator sites ensure that study inclusion/exclusion criteria are met prior to the enrollment of subjects into a clinical trial, and they are available to assist with the assessment of adverse events, concomitant medications, and overall subject safety. Medical monitors routinely participate in investigator meetings and safety committee meetings. As experts in the field, our medical monitors offer clients a level of service that only prior experience can provide.
Drugs don’t work in patients who don’t take them
– C. Everett Koop, MD