Centralizing ECGs for efficient, accurate cardiac safety assessments in clinical trials

Regulatory Overview Recent concerns over the cardiac effects of new pharmaceutical products have triggered greater regulatory scrutiny for all new compounds and final drugs prior to reaching the marketplace. While there is no legislative mandate in relation to ECG assessment across clinical trials, the requirement to conduct a Thorough ECG Trial (TET) for new compounds has been mandated by the US Food and Drug Administration (FDA) with limited exceptions. Centralizing the process of collection and standardization of quality ECG data and employing digital ECG systems and a core laboratory, not only reduces inconsistencies that may occur from site to site, but in addition helps to alleviate laboratory and site workloads.