Quintiles Transnational Corp. has launched QECG, an enhanced centralized electrocardiogram (ECG) service to help pharmaceutical and biotechnology companies analyze ECG data from clinical trials and use digital ECG data in submissions to regulatory authorities.
While Quintiles previously has provided ECG laboratory services, QECG uses the latest technology and enhanced service delivery to help customers benefit from the speed and quality of electronic ECGs read by experts at a central laboratory designed to comply with U.S., European and international regulatory requirements.
"The benefits of digital ECG submissions are so significant that U.S. and European regulatory authorities are now finalizing guidelines to mandate their use," said Anand Tharmaratnam, Executive Director of QECG. "We've seen substantial growth in demand for QECG's services as customers become aware of these pending guidelines and see the benefits of using a highly advanced central ECG lab such as ours.
"QECG operates round the clock, is designed to meet European CPMP (Committee for Proprietary Medicinal Products) and U.S. FDA requirements, and is subject to Quintiles' global quality assurance program."
Tharmaratnam said that QECG's distinct advantages for customers include:
* Cardiologists on site and available 24 hours a day, seven days a week, both for real-time and retrospective ECG review and signoff.
* Four-hour turnaround for cardiologist review and reporting on trans-telephonic ECG's, in which ECG data is transmitted in real-time by telephone to QECG cardiologists.
* QECG's data management platform, which uses the most advanced version of an Oracle-based clinical data management system.