Timothy Callahan, PhD

With significant technology advances in ECG recording through the years, the need to expand on traditional monitoring baselines-and include new variables such as time when designing clinical trial protocols-is important.

The US FDA, in open meetings, stated the Thorough QT trial "must" be replaced.

The sponsor of a recent Phase II global study, conducted at more than 50 sites, invested in a centralized digital pathology core lab to ensure a homogenous and representative study population.

The responsibilities regarding CV safety for drug developers are constantly evolving.

Centralized approach for Phase III studies enhances the quality and integrity of collected data.