“tQT data is now so important to the drug approval process, it is critical that we provide accurate results.” Jon Rojas, COO of WCCT.
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.
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.