Cetero Research, a US company that provides clinical pharmacology, bioanalytical and speciality Phase II-IV trial services, has forged a global strategic alliance with centralised cardiac testing specialist Cardiocore to optimise the design, conduct and reporting of cardiac safety studies.

The tie-up gives clinical trial sponsors direct access to “the world’s most experienced team of Thorough QT (TQT) scientists, unparalleled subject enrolment and bed capacity, integrated study management and accelerated data delivery”, the companies said. It will also streamline sponsors’ vendor selection, quality evaluation and contracting processes, they added.

Usually conducted in the earlier phases of drug development, TQT studies are cardiac safety trials that look at a drug’s impact on cardiac repolarisation by identifying and quantifying any prolongation of the QT/QTc interval. QT has been identified by regulators as a crucial cardiac safety marker and QTc prolongation is a known surrogate for assessing the cardiac safety risk of a new drug.

Cetero and Cardiocore have been jointly conducting TQT and other cardiac safety studies since the International Conference on Harmonisation published its E14 guideline on the clinical evaluation of QT/QTc interval prolongation in October 2005.

By formalising this collaboration through “the first true integration between a top clinical pharmacology contract research organisation and a top core lab, the Cetero-Cardiocore alliance is able to provide clients with a turnkey solution to their cardiac safety needs, with one contract, one project manager, and one final report”, commented Dr Jerry Merritt, chief executive officer (CEO) of Cetero Research.

“Cetero and Cardiocore are leading the industry in a positive new era where sponsors’ needs come first,” said Cardiocore CEO Jennifer Cotteleer. “To benefit sponsors, we have fully integrated study design, clinical conduct, project oversight, data interpretation and expert reporting … to ensure Thorough QT trials are performed correctly, completely and concisely.”