WCCT successfully completes a thorough QT cardiac safety study on schedule with a confinement period of 30 days with a complex exercise component.
Cypress, California (PRWEB) June 09, 2011
West Coast Clinical Trials (WCCT) has completed its most recent thorough tQT trial. This thorough tQT study, required a unique Modified Bruce Protocol component while collecting cardiac rhythm monitoring information on holter monitors for comparison with resting data. The project successfully demonstrates WCCT’s reliability in conducting a complex study of this nature and ability to acquire quality cardiac safety data. In addition to exceptional planning necessary to aquire quality QT interval data, the study sponsor was impressed with WCCT expertise in coordinating the Modified Bruce Protocol and in the site ability to overcome the obstacles of obtaining high quality cardiac rhythm data during exercise.
“tQT data is now so important to the drug approval process, it is critical that we provide accurate results.” Jon Rojas, COO of WCCT.
Since the ICH E14 Guidance was released, virtually every major regulatory agency around the world including FDA, EMEA, and Health Canada, require compounds with potential cardiac effects to undergo rigorous cardiac testing. Even drugs that have been FDA approved but undergo formulation modifications may require a thorough tQT study.
About West Coast Clinical Trials
WCCT is a privately owned early phase development CRO, conveniently located near 3 major airports in Southern California. WCCT was founded by Dr. Kenneth Kim who is board certified in Internal Medicine and Allergy and Asthma. Conducting trials since 1998, WCCT has been audited by the FDA and numerous pharmaceutical and biotechnology companies. WCCT’s location and access to an ethnically diverse population allows for a wide variety of study designs including ethnic bridging. With 150 beds in two locations and over 60,000 square feet, a well-trained and experienced staff, and advanced technological procedures, WCCT brings the highest quality to the pharmaceutical and biotechnology industries.