Centralized ECG Service for Clinical Trials

(Bracknell, UK) to help biotechnology and pharmaceutical companies analyze ECG data from clinical trials.

Although Quintiles has previously provided ECG laboratory services, the new QECG uses the latest technology and service delivery to enable customers to benefit from the speed and quality of electronic ECGs read by experts at a central laboratory and designed to comply with US, European, and International regulatory requirements.

The advantages of the service include cardiologists who are on site and available 24 hours a day, seven days a week, both for real-time and restrospective ECG review; four-hour turnaround for cardiologist review; and QECG's data management platform, which uses the most advanced version of an Oracle-based clinical data management system.

"The benefits of digital ECG submissions are so significant that US and European regulatory authorities are now finalizing guidelines to mandate their use,” said Anand Tharmaratnam, M.D., executive director. "QECG operates around the clock and is designed to meet European CPMP (Committee for Proprietary Medicinal Products) and US Food and Drug Administration (FDA) requirements.”




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