Nitrosamine Impurities Affecting Drug-Drug Interaction Studies – Learn More

Comprehensive Cardiac Safety Services

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.

Cardiac Safety Services

Cardiac Safety Services

Product Labeling

Should You Run a Dedicated TQT Study? Sponsor and Regulatory Considerations on Substitution Pathways to Assess QT Liability

Prevalence of Baseline Cardiac Arrhythmias in Participants with Overweight or Obesity in Phase 1 Clinical Trials: Analysis of 24-Hour Holter Electrocardiogram Recordings

Update on ICH E14/S7B Cardiac Safety Regulations: The Expanded Role of Preclinical Assays and the “Double-Negative” Scenario

QT Assessment in Early Drug Development: The Long and the Short of It

Evaluating Cardiac Risk: Exposure Response Analysis in Early Clinical Drug Development

Early Drug development: Assessment of Proarrhythmic Risk and Cardiovascular Safety

TQT Study Confirms Early PK/PD: High Dose Omarigliptin Doesn’t Prolong QTc Interval

Triplicate ECGs are Sufficient in Obtaining Precise Estimates of QTcF

Best Practices for Evaluating Clinical Proarrhythmia Risk in Early Drug Development