Covance Named Mortara Certified Partner for ECG Compliance with FDA's New Digital Standard
November 21, 2005
Princeton, NJ – Covance Inc. (NYSE: CVD) today announced that its global Cardiac Safety Services unit has achieved Mortara Certified Partner status for compliance with the digital electrocardiograph (ECG) standard now required by the U.S. Food and Drug Administration (FDA). This certifies that all ECG data Covance transmits to its biopharmaceutical sponsors is compatible with the FDA's new digital requirements, per the regulatory body's recent agreement with Mortara and its E-Scribe ECG Warehouse.
"With the increasing demand for ECG readings driven by ICH E-14 QT Guidance, it's imperative to have an efficient, accurate and flexible means of capturing, reading and submitting regulatory-ready cardiac safety data. The E-Scribe ECG Warehouse provides a key piece of the process," said Atul Minocha, General Manager of Covance's Cardiac Safety Services unit. "Covance's global biopharmaceutical clients may now leverage our proven operational processes, our leading-edge Digitography™ and Algorithm-assisted ECG Annotation technologies, as well as our renowned team of cardiologists to deliver timely, accurate, and standard data submissions directly to the FDA."
"In order for the E-Scribe ECG Warehouse to fulfill its promise, it’s essential that we have the support of the industry’s leading ECG Core Labs," said Justin Mortara, Vice President of Mortara Instrument. "We are pleased that Covance Cardiac Safety Services, one of the premier ECG labs, is one of our founding partners in this initiative.”
The E-Scribe ECG Warehouse, developed by Mortara in collaboration with the FDA, is the repository into which all annotated ECG datasets will be uploaded for regulatory review. In order to be uploaded into the warehouse, all annotated ECGs must pass through a validation step within the E-Scribe ECG Warehouse system that checks for adherence to the HL7 XML standard. FDA reviewers will use Mortara's data warehouse system to process ECG data received from sponsors in support of new drug applications (NDAs).
Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with annual revenues greater than $1 billion, global operations in 18 countries, and more than 7,000 employees worldwide. Information on Covance’s products and services, recent press releases, and SEC filings can be obtained through its website at www.covance.com.
Statements contained in this press release, which are not historical facts, are forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All such forward-looking statements including the statements contained herein regarding anticipated trends in the Company’s business are based largely on management’s expectations and are subject to an qualified by risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, competitive factors, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, the Company’s ability to continue to attract and retain qualified personnel, the fixed price nature of contracts or the loss of large contracts, and other factors described in the Company’s filings with the Securities and Exchange Commission.
Covance and the Covance logo are registered service marks and Digitography is a trade mark of Covance in the United States and other countries.