Thorough QT Studies

Cardiac safety risks, primarily associated with drug induced cardiac repolarization delays, have become a principal area of regulatory concern worldwide. In recent years, cardiac safety has become the most common cause for the Food and Drug Administration to withdraw previously approved drugs from the market. 

Sharpening the regulatory focus on cardiac safety, the International Conference on Harmonisation has authorized ICH E14: The Clinical Evaluation of QT/QTc Interval Prolongation Potential For Non-Antiarrhythmic Drugs. This guidance document defines the key components of a “Thorough QT study” (TQT) including data centralization, reader expertise, active control testing and timepoint replicates.

Since the early conceptual days of TQT testing, Cardiocore’s scientific experts have played a key leadership role, helping pharmaceutical and biotech organizations efficiently establish the cardiac safety profile of their compounds. Cardiocore scientists have participated in more than 50 Thorough QT projects including protocol design, study conduct, statistical analysis, expert reporting and regulatory presentations.

Cardiocore’s TQT experience spans a broad range of therapeutic areas including Oncology disease categories that require advanced protocol design expertise. As a global leader in QT testing, Cardiocore has conducted TQT studies for Top Ten pharmaceutical firms, mid-range specialty pharmaceutical companies, and emerging biotech organizations. These studies have been conducted at many of the world’s leading clinical pharmacology units.

Cardiocore’s scientific expertise is complemented by its highly experienced TQT project teams and sponsor-benefiting technologies. During days of intensive data acquisition, Cardiocore’s project managers provide hands-on support at the clinical pharmacology unit, helping to ensure completeness and consistency. To ensure data security, many sponsors rely upon Cardiocore’s HolterGateway  system for advanced digital transfer of Thorough QT data.

Click here  to learn more about how Cardiocore can help your organization plan, design, conduct and analyze your Thorough QT studies.