| COVANCE IS PREPARED FOR NEW EMEA ELECTRONIC REPORTING REGULATIONS |
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Princeton, New Jersey, April 8, 2003 — Covance Inc. (NYSE: CVD) announced today that it has successfully completed the first test of delivering safety adverse event (SAE) reports electronically to the European Agency for Evaluation of Medicinal Products (EMEA). The report was delivered in the required E2B compliant format using a broadly accepted industry software system. This accomplishment places Covance at the forefront of companies able to comply with the new electronic SAE reporting required by the EMEA.
The practice of submitting SAE reports on paper led to transcription errors, lost documentation, and delays in obtaining results, all of which introduced patient safety issues. This is evident in 12 drugs being withdrawn from the market since 1997 due to adverse drug reactions. Advances in electronic submissions now provide cost-effective alternatives to paper-based reporting that reduce these issues related to patient safety. The EMEA, in an effort to safeguard patient safety and improve the efficiency of reporting safety adverse events, made electronic safety reporting mandatory for marketed products in Europe starting January 31, 2003. Similar EMEA regulations for clinical trials are expected in 2004, with the FDA following suit in the near future.
"Covance is at the forefront of offering electronic SAE reporting for our pharmaceutical and biotechnology clients, either as a stand-alone service or combined with full clinical trial support," said Mark Bradshaw, Vice President, Global Biometrics, Data Management, and Clinical Information Technology at Covance. "These innovative data management solutions better meet our clients' needs and help enhance continued regulatory compliance. The implementation of the web-based safety reporting system, combined with the company's global data management platforms, including Oracle Clinical v4.03, enables Covance to meet data management needs from Phase I through Phase IV to provide truly combinable data across all phases of drug development."
Combinable data is an achievable goal with the global data management initiatives undertaken by Covance. Data produced anywhere in the world can now be offered to customers without the need for normalization or reformatting. Global web-based systems across the drug development process will provide near real-time data that will allow pharmaceutical sponsors to make critical clinical trial decisions sooner and speed submissions.
Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with 2002 net revenues of $883 million, global operations in 17 countries, and approximately 6,900 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.
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 and 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, 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. |
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