We work with you to determine the ideal approach for measuring the QT prolongation effect of your new compound or formulation by partnering with core ECG labs for the data collection and analysis.
Some sponsors choose to add early cardiac safety assessment to their first-in-human studies, while others wait for later development and perform a Thorough QT prolongation study. Regardless of your approach, Altasciences can help you with the design.
The design and conduct of studies focused on ECG measurement revolve around reducing variability in the measures, as this allows the studies to be conducted with smaller sample sizes. We consider the impact of clinical events like blood draws, and also limit other stimuli. We ensure that when the ECGs are taken, there are no events that affect heart rate.
- Healthy Normal Volunteers
- 11 studies involving cardiac Intense/Concentration QT/TQT (IQT/TQT) assessments since 2016
- More than 28 studies historically that involved cardiac (IQT/TQT) assessments
- Awarded multi-year, multi-million dollar contracts by NIH/NIDA and FDA
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.