Drug-induced delayed ventricular repolarization can be an undesirable effect of a new molecular entity, as it has been associated with life-threatening and lethal ventricular arrhythmias. Therefore, regulatory agencies recommend that cardiac safety be evaluated during early drug development.
As the world’s largest CRO with an integrated ECG core laboratory, rely on Celerion’s experience and expertise for study designs, data collection and analysis to satisfy either a TQT substitution request or dedicated TQT study. Our cardiac safety experts are not only involved in aspects of study design and conduct but also actively contribute to the field early-phase proarrhythmia risk assessment. Check out our multiple peer-reviewed publications and other resources addressing recent advances in the regulatory science of cardiac safety.