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New Livelink Solution Improves Information Management in Clinical Trials for New Drugs
Gives Pharmaceutical Companies a Specialized Solution for Managing Huge Volumes of Trial Data and Reports
Chicago, IL - 2002-11-18 - Open Text™ Corporation (Nasdaq: OTEX, TSX: OTC), provider of Livelink®, the leading collaboration and knowledge management software for the global enterprise, today introduced Livelink for Clinicals, which gives pharmaceutical companies a complete solution for managing information and reports during the clinical trials phase of the drug approval process. Livelink for Clinicals helps ensure compliance with government regulations and improves time-to-market speed for new products.
The solution is the second in a series of new Livelink offerings being introduced by Open Text to meet the needs of pharmaceutical and life sciences companies. The product works with Livelink for Regulated Documents, which Open Text announced last week to provide end-to-end lifecycle support for all documents created as companies develop and gain approval on new drugs. Livelink for Clinicals helps pharmaceutical companies reduce costs and improve accuracy, while speeding the time to “data lock,” the point at which clinical trials can be closed and researchers can begin to assess results.
"The clinical trials phase is the most critical of the drug approval process and one that's fraught with enormous risks and costs if trial documents and data aren't carefully managed," said Martin Sumner Smith, vice president of pharmaceutical solutions for Open Text. "Customers need a way to ensure that the huge volumes of clinical trial information, sometimes upwards of 7,000,000 pages of documentation in a single year, are properly maintained, while helping to speed the trial process so companies can get products to market faster. Livelink for Clinicals meets those needs by addressing important requirements at each stage of a clinical trial."
Even before clinical trials can begin, Livelink for Clinicals offers important capabilities to pharmaceutical company researchers to help them launch trials quickly. Livelink for Clinicals automates the process for coordinating and maintaining all required regulatory documentation, such as detailed contracts with each clinical trial site, informed consent forms from the trial subjects, and credentials of all investigators participating in the study. Livelink for Clinicals gives users an easy way to manage documents, combined with workflows to coordinate critical document approvals in the study start-up period. The solution helps ensure accuracy, while speeding the time between when the first contract is signed with a site and when the first patient visit occurs. It also ensures a fast and compliant response in the event of an audit of the trial by regulatory agencies, such as the U.S. Food & Drug Administration, or Institutional Review Boards.
During clinical trials, Livelink for Clinicals improves the Case Report Forms (CRF) tracking process. Managing CRFs, which detail how individual patients react to a new drug, is a labor-intensive process for pharmaceutical companies and contract research organizations, requiring clinical researchers to collect forms and data entry clerks to manually enter details from each form. Livelink for Clinicals lets research staff scan reports and store each as an image in Livelink, making them easy to search and retrieve. Livelink for Clinicals also automatically generates casebooks of reports by assembling and indexing CRF images into a single document, with links so that it can be easily navigated.
Livelink for Clinicals also helps researchers manage information for Severe Adverse Event (SAE) forms, which detail adverse reactions to new drugs among patients in a trial. When SAE documents are scanned or faxed in, Livelink for Clinicals allows researchers to not only maintain all records for an SAE, it also incorporates detailed workflows to coordinate, track and ensure a fast response, for example, warning other clinical trial sites and the appropriate regulatory agencies about the event in a timely manner.
The solution is the second in a series of new Livelink offerings being introduced by Open Text to meet the needs of pharmaceutical and life sciences companies. The product works with Livelink for Regulated Documents, which Open Text announced last week to provide end-to-end lifecycle support for all documents created as companies develop and gain approval on new drugs. Livelink for Clinicals helps pharmaceutical companies reduce costs and improve accuracy, while speeding the time to “data lock,” the point at which clinical trials can be closed and researchers can begin to assess results.
"The clinical trials phase is the most critical of the drug approval process and one that's fraught with enormous risks and costs if trial documents and data aren't carefully managed," said Martin Sumner Smith, vice president of pharmaceutical solutions for Open Text. "Customers need a way to ensure that the huge volumes of clinical trial information, sometimes upwards of 7,000,000 pages of documentation in a single year, are properly maintained, while helping to speed the trial process so companies can get products to market faster. Livelink for Clinicals meets those needs by addressing important requirements at each stage of a clinical trial."
Even before clinical trials can begin, Livelink for Clinicals offers important capabilities to pharmaceutical company researchers to help them launch trials quickly. Livelink for Clinicals automates the process for coordinating and maintaining all required regulatory documentation, such as detailed contracts with each clinical trial site, informed consent forms from the trial subjects, and credentials of all investigators participating in the study. Livelink for Clinicals gives users an easy way to manage documents, combined with workflows to coordinate critical document approvals in the study start-up period. The solution helps ensure accuracy, while speeding the time between when the first contract is signed with a site and when the first patient visit occurs. It also ensures a fast and compliant response in the event of an audit of the trial by regulatory agencies, such as the U.S. Food & Drug Administration, or Institutional Review Boards.
During clinical trials, Livelink for Clinicals improves the Case Report Forms (CRF) tracking process. Managing CRFs, which detail how individual patients react to a new drug, is a labor-intensive process for pharmaceutical companies and contract research organizations, requiring clinical researchers to collect forms and data entry clerks to manually enter details from each form. Livelink for Clinicals lets research staff scan reports and store each as an image in Livelink, making them easy to search and retrieve. Livelink for Clinicals also automatically generates casebooks of reports by assembling and indexing CRF images into a single document, with links so that it can be easily navigated.
Livelink for Clinicals also helps researchers manage information for Severe Adverse Event (SAE) forms, which detail adverse reactions to new drugs among patients in a trial. When SAE documents are scanned or faxed in, Livelink for Clinicals allows researchers to not only maintain all records for an SAE, it also incorporates detailed workflows to coordinate, track and ensure a fast response, for example, warning other clinical trial sites and the appropriate regulatory agencies about the event in a timely manner.
About Livelink
Livelink is the leader in collaboration and knowledge management for the global enterprise. Its richly-featured enterprise services include virtual team collaboration, business process automation, enterprise group scheduling and information retrieval services, all tightly integrated into a solution that is easily customized and extended. Livelink is essential to the effective management and development of communities of interest that span organizations and industries. For everything from the creation of complex e-community relationships to the automation of simple e-business processes, Livelink delivers true dynamic collaboration between individuals, organizations and large trading communities. Livelink servers are fully Web-based and open-architected to ensure rapid deployment and easy access to its full functionality through a standard Web browser. For more information, visit www.opentext.com/livelink/.
About Open Text
Since 1991, Open Text Corporation has delivered innovative software that brings people together to share knowledge, achieve excellence, deliver innovation, and enhance processes. Its legacy of innovation began with the successful deployment of the world’s first search engine technology for the Internet. Today, as the leading global supplier of collaboration and knowledge management software for the enterprise, Open Text supports six million seats across 4,500 corporations in 31 countries and 12 languages throughout the world. As a publicly traded company, Open Text manages and maximizes its resources and relationships to ensure the success of great minds working together. For more information, visit www.opentext.com.
Trademark
Copyright © 2002 by Open Text Corporation. LIVELINK, LIVELINK MEETINGZONE, 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 deployment of Livelink and Livelink MeetingZone by customers, and future performance of Open Text Corporation. Forward-looking statements 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 final prospectus for the Company's initial public offering of common stock in January 1996, Form 10-K for the years ended June 30, 1998, June 30, 1999, June 30, 2000, and June 30, 2001, and Form 10-Q for the quarters ended September 30, 2001, December 31, 2001 and March 31, 2002. Forward-looking statements 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
Director, Industry Analyst Relations
Open Text Corporation
+1-519-888-7111 ext.2410
mdobbin@opentext.com
