COVANCE CENTRAL DIAGNOSTICS CERTIFIED AS ISO 9001
Certification Positions Electrocardiogram and Imaging Services Provider as an Industry Leader |
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Reno, Nevada, 9 January 2002 — Covance Inc.'s (NYSE: CVD) Central Diagnostic facility in Reno, Nevada solidified its position as a leader in centralized electrocardiogram (ECG) and centralized imaging services by announcing today that it has won certification as compliant with ISO 9001, a globally recognized gold standard for quality assurance.
"What this means for our customers is that we remain a leader in quality management within the ECG and imaging services industry, and that we offer consistent trial support from start to finish for each and every trial," said Eileen Daniel, Vice President and General Manager of Covance Central Diagnostics. "Being certified to ISO 9001 confirms for customers that our processes are consistent and reproducible."
ISO is an internationally recognized reference for quality requirements in business-to-business services. ISO 9001 is the most comprehensive of the approximately 13,000 ISO standards and is a model for quality assurance in design, development, production, installation, and servicing. To win certification, Covance successfully completed an independent Quality Audit for Quality Management System Registration of the EN ISO 9001, EN 46001, and EN ISO 13485 standards.
The certification was conducted by MedCert GmbH of Hamburg, Germany, which stated: "Covance has introduced and applies a Quality Management System in the area of design, manufacture, final inspection, and service of electrocardiogram devices and diagnostic testing services for the pharmaceutical industry."
Covance's ISO 9001 certification is well timed, given the fast approach of FDA's proposed demanding NDA submission standards that are expected to require mandatory submission of digital ECG files. The implementation of the new guidelines is expected by this May, and all NDA submissions are expected to be compliant by fall 2002.
Covance acquires original ECG signals and images digitally through the use of the proprietary systems. Once ECG signals are received, Central Diagnostics verifies the quality of the signal in real-time, then all ECG data are reviewed by Board-certified cardiologists who provide consistent interpretations.
Pharmaceutical and biotechnology companies interested in finding out more about the benefits of capturing ECGs digitally through an ISO 9001-certified central diagnostic location may contact a digital ECG specialist at Covance Central Diagnostics by calling 1-888-COVANCE (888-268-2623).
To learn about other benefits of centralized ECG services, attend a Covance-sponsored, in-depth and detailed educational e-Conference on 10 January 2002 at 11 a.m. The topic will be the new proposed FDA regulations on digital ECG standardization and their impact on the drug development process.
Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with 2000 pro forma revenues of $737 million, operations currently in 17 countries, and approximately 7,200 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through the website in the About Covance area. |
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