RESEARCH TRIANGLE PARK, N.C. – February 24, 2004 – Quintiles Transnational Corp. today announced the creation of Integrated Cardiac Safety Services, designed to meet the increasing demand for cardiac safety data in the drug approval process.
"Pharmaceutical and biotechnology companies must prepare for higher expectations regarding cardiac safety data from US and European regulatory agencies as well as the International Committee on Harmonization (ICH)," said David Dworaczyk, Ph.D., Quintiles' Senior Vice President, 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."
In the last 10 years, regulatory agencies have withdrawn or denied approval to several drugs that adversely affect the heart, prolonging what is called the QT interval. The QT interval measures the duration of ventricular repolarization. A prolonged QT interval can lead to a potentially fatal arrhythmia. The ICH guidelines, which describe tests to determine whether drugs prolong the QT interval, 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' ECG services are available 24 hours a day, seven days a week, 365 days a year with a full-time cardiologist on staff at all times. Quintiles' international ECG Helpdesk also is available 24 hours a day, seven days a week, supporting more than 35 different languages. For more information, visit the Cardiac Safety Web site.
Quintiles helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Headquartered near Research Triangle Park, North Carolina, and with offices in more than 40 countries, Quintiles is a leading global pharmaceutical services organization and a member of the Fortune 1000. For more information visit the company's Web site at www.quintiles.com.