Cardiac Safety in Clinical Development
QT/QTc studies are essential for assessing a drug’s cardiac safety and are a critical component of any new drug application. With our specialized expertise, controlled environments, and rigorous quality standards, we help biopharmaceutical companies generate reliable cardiac safety data to advance your drug development programs with confidence.
Expertise in Cardiac Safety Studies
We specialize in a range of cardiac safety assessments, including:
- Thorough QT/QTc (TQT) studies
- Crossover and parallel group studies to evaluate QT/QTc interval prolongation risk
- ECG collection at multiple time points under controlled conditions for early dose-ranging studies
- Polarization studies
Advanced Procedures for Reliable Data
Our Unified Site Methodology across sites ensures rigorous, high-quality data that can be swiftly collected, harmonized, and confidently integrated into regulatory submissions. We conduct cardiac safety trials with meticulous attention to data integrity, eliminating variables that could introduce noisy data. Our study environments are custom-configured to control temperature, humidity, and noise levels, ensuring consistent data collection.
Our staff undergoes rigorous training in:
Standardized skin preparation, lead placement, and patient positioning
Blinded conditions to minimize inter- and intra-reader variability
Use of ambulatory ECG monitoring, 12-lead ECGs, and bedside monitoring (pulse oximetry, ECG, vital signs)
All equipment is regularly calibrated and serviced to maintain the highest standards of accuracy.
Regulatory Alignment for Late-Phase Trials
Per FDA guidance, the degree of QT prolongation at therapeutic doses dictates ECG monitoring intensity in late-phase trials. Our expertly executed TQT studies provide the precision needed to meet regulatory expectations and ensure patient safety.
Partner with Us for Your Next Cardiac Safety Study
