Quintiles says it has developed Integrated Cardiac Safety Services to meet the demand for cardiac safety data in the drug approval process.

“Pharmaceutical and biotechnology companies must prepare for higher expectations regarding cardiac safety data from U.S. and European regulatory agencies as well as the International Committee on Harmonization (ICH),” said David Dworaczyk, Quintiles’ senior vice president of integrated technologies. “Quintiles’ extensive cardiac safety capabilities can help sponsors evaluate cardiac safety of drugs at any place in the development continuum, from preclinical through Phase IV, and customers can be assured of high-quality work because we use only experienced Quintiles personnel.”

ICH guidelines describe tests to determine whether drugs prolong the QT interval, which measures the duration of ventricular repolarization and if prolonged can lead to a potentially fatal arrhythmia. The guidelines are now well into the ICH review and approval process and will be further refined over the next year. When finalized, the regulations would require that all drugs, regardless of therapeutic area, be thoroughly evaluated for cardiac safety.

“Our continuum of service focuses on three key elements…preclinical cardiac safety pharmacology, Phase I clinical pharmacology and centralized ECG analysis, monitoring and reporting,” Dworaczyk said. “We integrate these elements into a seamless process that can help every organization, regardless of size, generate and interpret the right data from all phases of development, save time and money in the development of their drug, while maintaining high quality.”

Quintiles: www.quintiles.com