Case Study: Pharmaceutical Company achieves FDA-accepted cardiac safety assessment and favorable labeling in Phase I/II oncology trial with Clario

Clario helps establish the cardiac safety profile of a novel oncologic in early phase

Pharmaceutical Company ran a Phase I/II solid‑tumor trial across 40 U.S. and European sites and needed to establish the investigational drug’s cardiac safety despite challenges from patient comorbidities, concomitant medications and high data variability. They engaged Clario to support concentration‑QTc (C‑QTc) assessment, using time‑matched triplicate 12‑lead ECGs, 12‑lead Holter devices, centralized ECG overreads and regulatory‑ready reporting.

Clario provided expert study design and data‑collection direction, site training, centralized ECG interpretation, retrospective ECG extraction/measurement for C‑QTc analysis, and the EXPERT report and regulatory datasets/xmls. The result was reliable, low‑variability cardiac data that established QT risk in a complex oncology population, gained FDA acceptance enabling a favorable label, and avoided a more costly follow‑on QT study.