News

Livelink Solution Transforms Regulatory e-Submissions for New Drug and Medical Device Applications
Improves Processes and Accuracy for Complex Regulatory Submissions
Chicago, IL - 2004-01-27 - Open Text™ Corporation (Nasdaq: OTEX, TSX: OTC), provider of Livelink®, the leading collaboration and content management software for the global enterprise, said today it is introducing a new solution that gives life sciences companies a single, unified environment for managing the complex process of assembling, approving, releasing and archiving new drug and medical device applications required to enable human clinical trials and product marketing. Livelink for Collaborative Submissions supports the complete lifecycle of the submissions process, providing tools to exchange information with government regulators, as well as manage and track changes to millions of pages of documents from multiple submissions.

Applications for regulatory approvals in life sciences have evolved from massive paper document collections submitted all at once, to a rolling, electronic-submissions process requiring ongoing coordination with regulators. The process has grown in complexity despite attempts at simplification such as the adoption by regulators worldwide of a standard format for drug and biological product applications called the Electronic Common Technical Document or eCTD. Rolling submissions require both the regulators and the submitting company to maintain identical document repositories throughout the submission's lifecycle. The challenge is managing changes to information within the company and re-synchronizing those changed documents with those being reviewed by regulatory authorities.

Livelink for Collaborative Submissions offers a single, end-to-end system to manage eCTD-compliant submissions to the U.S. Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other regulators worldwide. The solution combines document, forms and records management software, content publishing tools and the ability to automate a wide range of processes, from ad hoc to tightly sequenced workflows. Integrated tools such as check-in/out, version history, event auditing, signing controls, alternate renditions and compound documents make it easy to manage documents, their constituent documents and related components to ensure accuracy.

“We created Livelink for Collaborative Submissions to offer customers a single platform to manage submissions information and synchronize changes with the multiple regulatory authorities in major global markets,” said Martin Sumner-Smith, Vice President of Pharmaceutical Solutions at Open Text. “It can also manage a far wider range of submission types than any other product, and as such is the first dossier management system for all product-related submissions.”

Other key features of Livelink for Collaborative Submissions include:

  • Easy access to other file and content systems across the enterprise from Livelink to retrieve documents, data sets and other content needed in a submission.
  • Uniform, pre-defined taxonomies for organizing submission documents based on the eCTD with flexible extension capabilities.
  • Role-based access controls that tightly regulate access rights and permissions according to the roles of participants in the creation, assembly and publishing of submission documents.
  • Desktop integration so users can drag-and-drop items into Livelink directly from the Windows desktop in online or offline mode, using Microsoft Office, Adobe Acrobat, Windows Explorer, and WebDAV-compliant applications.
  • The necessary controls to be deployed as a ‘closed system’ available over the Internet for secure, convenient access by traveling staff, partners and research physicians.

Livelink for Collaborative Submissions also complies with laws such as the FDA’s 21 CFR Part 11 rules for electronic submissions. The product is being deployed in pilot customer sites and will be released in Spring 2004. For more information on the product, go to:
www.opentext.com/pharmaceutical/livelink-for-collaborative-submissions.html.



Product Showcased at Upcoming Conferences Open Text will be showcasing Livelink for Collaborative Submissions at two upcoming life sciences conferences:

IIR E-Submissions 2004
January 27-28 in Washington D.C.
For more information:
www.opentext.com/events/event.html?id=35203



17th Annual Drug Information Association’s Electronic Document Management Conference
February 17-19 in Philadelphia
For more information:
www.opentext.com/events/event.html?id=35202.

About Open Text and Livelink
Open Text™ is the market leader in providing Enterprise Content Management (ECM) solutions that bring together people, processes and information in global organizations. Since launching the world's first Internet search engine and the first Web-based enterprise collaboration and knowledge management software, Open Text has continued its leadership in providing global enterprises with innovative and effective solutions. Throughout its history, Open Text has matched its tradition of innovation with a track record of financial strength and growth. Today, the company supports fifteen million seats across 10,000 deployments in 31 countries and 12 languages worldwide. Open Text’s flagship product, Livelink® seamlessly combines collaboration with content management, helping organizations transform information into knowledge to provide the foundation for innovation, compliance and accelerated growth. For more information on Open Text and Livelink, go to: www.opentext.com and www.opentext.com/products/livelink/enterprise-server.
Trademark
Copyright © 2003 by Open Text Corporation. LIVELINK and OPEN TEXT are trademarks or registered trademarks of Open Text Corporation in the United States of America, Canada, the European Union and/or other countries. This list of trademarks is not exhaustive. Other trademarks, registered trademarks, product names, company names, brands and service names mentioned herein are property of Open Text Corporation or other respective owners.
Release Disclaimer
This news release may contain forward-looking statements relating to the success of any of the Company’s strategic initiatives, the Company’s growth and profitability prospects, the benefits of the Company’s products to be realized by customers, the Company’s position in the market and future opportunities therein, the deployment of Livelink and our other products by customers, and future performance of Open Text Corporation. Forward-looking statements may also include, without limitation, any statement relating to future events, conditions or circumstances. Forward-looking statements in this release are not promises or guarantees and are subject to certain risks and uncertainties, and actual results may differ materially. These risks and uncertainties include, among others, risks involved in the completion and integration of acquisitions, the possibility of technical, logistical or planning issues in connection with deployments, the continuous commitment of the Company's customers and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Form 10-K for the year ended June 30, 2002, and Form 10-Q for the quarters ended March 31, 2003, June 30, 2003 and September 30, 2003. You should not place undue reliance upon any such forward-looking statements, which are based on management's beliefs and opinions at the time the statements are made, and the Company does not undertake any obligations to update forward-looking statements should circumstances or management's beliefs or opinions change.
For more information, please contact
Margaret E. Dobbin
Director, Industry Analyst Relations
Open Text Corporation
+1-519-888-7111 ext.2410
mdobbin@opentext.com
Richard Maganini
Open Text Corporation
1-847-961-0662
rmaganin@opentext.com

 
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