|Beth Ambaruch||Sep 18, 2002 8:04 am|
|Subject:||[announce] Arbortext Focuses on Life Sciences|
|From:||Beth Ambaruch (be...@arbortext.com)|
|Date:||Sep 18, 2002 8:04:42 am|
Arbortext Focuses on Life Sciences
Provides XML solutions to address pharmaceutical manufacturing, pharmaceutical package inserts and labels, and regulatory submission challenges
ANN ARBOR, Mich., September 17, 2002 -- Arbortext, Inc., the only global provider of XML-based software for multichannel publishing, today announced its focus on the life sciences industry that includes new product capabilities and new applications. This initiative enables pharmaceutical companies, medical device manufacturers and biotechnology companies to bring new and revised products to market faster than ever while complying with complex regulatory requirements, ultimately avoiding costly penalties such as manufacturing delays, regulatory fines and missed revenue opportunities.
The new applications are a combination of Arbortext core products, partner integration and consulting services. Arbortexts Epic software provides the cornerstone for organizations to efficiently create, manage and publish complex business and technical documents, such as new drug applications, product information (package inserts, leaflets and labels), and written documentation of procedures that support the methods, facilities and controls used in the preparation, processing and packaging of pharmaceutical and medical products.
Some of the new product capabilities to support this initiative include: · Change tracking · Enhanced API including support for Active-X · Stronger integration with Documentums content management system · Digital signatures and watermarks
Arbortext provides support for the following applications in life sciences: · Pharmaceutical Manufacturing. With fines related to manufacturing process documentation reaching as high as $500 million, drug companies have a powerful incentive to automate the documentation process to reduce the risk of incomplete, incorrect or out-of-date information. Arbortext consolidates manufacturing documentation into a single source and process that eliminates redundancy and ensures that all information is consistent and comprehensive. Arbortexts Epic software enables drug manufacturers to maintain regulatory compliance, prevent costly errors and avoid fines. Benefits include faster authoring, quicker revision and review cycles, higher content quality through information reuse, automated formatting and publishing for multiple purposes and in multiple formats, and penalty reduction as a result of FDA compliance. · Pharmaceutical Package Inserts and Labels. Package inserts, leaflets and labels present a particular challenge to the pharmaceutical industry as they must be modified for each form, dosage and presentation of medication as well as be delivered in the native language of the consumer. In Europe, it can take as many as 900 different documents to support a single drug. By producing the entire set of documents automatically from a single source file, Arbortexts Epic software reduces the resources needed to create, submit, approve and maintain this product information. Benefits include both lower costs and faster approvals by focusing review and approval on the changes since the previous revision. · Regulatory Submissions. Regulatory submissions consist of large amounts of complex information that must be assembled and submitted to the regulatory agencies of each country or region where the submitting company plans to market a product. For each day the product is delayed going to market, it can cost the manufacturer $1 million or more. Arbortexts Epic software enables these organizations to meet the requirements of XML-based submissions because of its capacity to automate the creation, validation and distribution of large collections of modular data. Benefits include better document maintenance by streamlining internal company processes to support the regulatory approval process. The end result is getting products to market faster and increasing revenue.
Rising drug costs and increased regulatory requirements are just a few of the challenges that life sciences organizations are facing, said Tom DiCorcia, Industry Marketing Director at Arbortext. Being first to market with new drugs, avoiding manufacturing fines from the FDA, and speeding up regulatory submission processes are critical to maintaining market leadership. Arbortexts focus on certain pharmaceutical applications will provide pharma companies with a way to increase efficiencies in the manufacturing, regulatory compliance and product information initiatives, ultimately increasing revenues and shareholder value.
Arbortext has long been a pioneer in XML authoring and publishing software, said Ron Schmelzer, Senior Analyst at ZapThink. Arbortext has shown that is able to offer high-quality, focused software to support every aspect of the drug development lifecycle from discovery, clinical trials and regulatory approvals to manufacturing, marketing and medical affairs.
Arbortext customers in the life sciences industry include Abbott Laboratories, American Medical Association, AstraZeneca, Beckman Coulter, Bristol-Myers Squibb, Canadian Pharmacists Association, GE Medical Systems, Guidant CPI, GlaxoSmithKline, Kimberly Clark, M&R Care Guidelines, Medtronic, Merck, MicroMedics, Novant Health, Pfizer, Pharmacopeia-Europe, Pharmacopeia-United States and Sanofi-Synthelabo.
About Arbortext Arbortext is the only global provider of XML-based multichannel software that enables the creation, editing and publishing of information to multiple media types Web, print, CD-ROM, wireless from a single source of content. Shipping since 1991, Arbortexts standards-based software supports technical publishing, reference publishing and business publishing applications that enable enterprises to provide more accurate, cost-efficient, complete, timely, consistent and usable information on all media. Arbortexts software is installed at over 300 large multinational organizations. Current customers include American Express Financial Services, Audi, Boeing, British Aerospace, Caterpillar, DaimlerChrysler, Ericsson Telecom, Ford, General Electric, GM, IBM, International Thomson Publishing, Lucent, Nokia, Nortel Networks, PeopleSoft, Pfizer, Qantas, Ricoh, Sun Microsystems, United Airlines, Volkswagen, Volvo and West Group. Arbortext is a founding member and active participant in the XML Activity of the World Wide Web Consortium (W3C). Headquartered in Ann Arbor, Michigan, USA, Arbortext has offices around the world. For more information please visit http://www.arbortext.com. # # #