COVANCE PREPARED FOR e-COMPLIANCE
Advanced technology used for electronic document management and regulatory submission filing |
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Princeton, New Jersey, March 8, 2000 — Covance Inc. (NYSE: CVD) announced a new e-compliance (electronic compliance) service in partnership with industry-leading companies in e-compliance management. Covance now has the technology to manage its clients' documents electronically throughout the clinical trial process, culminating in a complete electronic filing of a New Drug Application (NDA).
Using Documentum, Inc. software for electronic document management and the CoreDossier® software suite from ESPS, Inc. (Nasdaq:ESPS) for electronic publishing, Covance can assemble, publish, and file regulatory submissions that comply with Food and Drug Administration (FDA) electronic filing guidelines. "This technology provides Covance with another way to reduce the time and cost of drug development by streamlining the regulatory approval process," said Gregory Miller, Director of Regulatory Affairs Records & Documentation & Electronic Submissions. In addition, these tools enable Covance to offer clients electronic dossier components, such as study reports, on an as-needed basis.
"Working with a premier contract research organization such as Covance, we look forward to helping clients improve their electronic submission processes, and achieve measurable improvements to their submission quality," said Jeffrey Sager, Vice President of Sales, ESPS.
The FDA is aggressively moving toward an electronic regulatory submission environment as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. FDAMA was enacted to help the FDA get safe and effective new medicines to patients sooner. The FDA is pursuing a number of strategies to accomplish this. One of the key strategies is using information technology to streamline the regulatory review process. Electronic submissions will provide FDA reviewers with quicker access to information, as well as provide potential time and cost savings during product development for pharmaceutical companies.
Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with 1999 revenues of $829 million, global operations, and approximately 7,500 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through our website at: www.covance.com.
About Documentum:
Documentum, the leading provider of Internet-scale content management solutions for powering eBusiness applications, offers solutions that integrate dynamic content, complex business processes and people everywhere - enabling seamless collaboration, communication and knowledge sharing between employees, suppliers and customers. Documentum offers the only open, standards-based content management platform and applications suite for managing complex processes as well as any content type, in a truly collaborative environment - enabling trusted content to be delivered to the right person at the right time on any information device, regardless of its origin or location. Documentum's highly adaptable collaboration and content management solutions enable corporate developers and Internet System Integrators to quickly implement robust eBusiness applications with the reliability, scalability and interoperability required by today's 24x7 Internet economy. These eBusiness applications powered by Documentum help more than 800 global customers dramatically improve their top line by accelerating product lifecycles, re-architecting business processes, improving operational efficiency and turning knowledge into a corporate asset. Headquartered in Pleasanton, Calif., Documentum software and services are sold through a direct sales force, systems integrators and affiliated distributors worldwide.
About ESPS:
ESPS, Inc. (Nasdaq: ESPS) provides knowledge publishing solutions that accelerate the assembly, management and exchange of diverse business-critical information for the eWorld. Since 1995, ESPS has been the leading developer of e-Publishing software products that address the needs of companies faced with compound document publishing requirements through the application of industry expertise, advanced technology and a commitment to high-quality implementations. The ESPS world headquarters is located in suburban Philadelphia, with additional offices throughout North America and Europe.
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 and financial performance and the performance of the Company's common stock 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 multiple capability contracts, and other factors described in the Company's filings with the Securities and Exchange Commission. |
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