Monitoring

Clinical Monitoring

Clinical monitoring is a required element of all Phase I and Phase II clinical trials. According to ICH guidelines, monitoring is conducted to protect the rights and well-being of human subjects, to ensure that clinical trial data is accurate, complete, and verifiable, and to confirm that the conduct of trials is in compliance with Good Clinical Practices (GCPs).

Clinilabs provides clinical monitors for drug and device trials conducted in the United States, Europe, Asia, and South America. Our monitoring teams may be composed of “in-house” monitors, regional freelance monitors, or a combination of both. Our in-house team provides leadership, and regional monitors add therapeutic area expertise in specific geographic regions, bringing together valued clinical expertise with an understanding of local customs. Our monitors conduct pre-study visits, site initiation visits, and routine monitoring visits used to verify source data and case report form entries, generate and resolve queries, and generally ensure that studies are conducted in accordance with protocol and regulatory requirements.

We hire, train, and deploy sophisticated, experienced monitoring teams that understand the unique elements of early-phase studies.

Medical Monitoring

Clinilabs’ medical monitors are experts in monitoring Phase I and II clinical trials. Our team consists of experts in a variety of therapeutic areas who oversee studies with 24/7 medical coverage. 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 safety committee meetings for Phase I studies.  As experts in their fields, our medical monitors offer clients a level of service that only prior experience can provide.

 

 

Click HERE to download our Multicenter, Full Service CRO Case Study.