Operationalizing 30-minute ECG review

Case Study

Operationalizing 30 minute ECG review

Addressing the unique post-marketing cardiac safety monitoring requirements of an autoimmune disease product.

Customer needs to respond to regulatory guidance issued on rigorous monitoring of cardiac safety by clinics six hours post-dose, with reporting requirements varying across geographies – because of the risk of transient bradycardias and heart block after the first dose, the FDA heightened the recommended level of cardiovascular monitoring of all patients after their first dose At the time, no clinical services provider had resources in place to facilitate expedited analysis. Learn how IQVIA has been able to accommodate a 30-minute ECG review turn around with high quality delivery since 2012.