Covance Named Mortara Certified Partner for ECG Compliance with FDA's New Digital Standard
Released on = November 21, 2005, 1:00 pm
Press Release Author = Covance Inc.
Industry = Pharmaceuticals
Press Release Summary = Permits biopharmaceutical sponsors to leverage Covance
cardiologists, operations and leading-edge ECG technologies to deliver timely,
accurate submissions directly to FDA
Press Release Body = Princeton, NJ, November 21, 2005 -- 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).
About Covance
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.
Web Site = http://www.covance.com/news/pressrel/2005/051121.php
Contact Details = Covance Inc.
210 Carnegie Center
Princeton, NJ 08540
Marketing Communications
609 452 4159
pr@covance.com
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