CDC Solutions Announces Xref Manager as a Key Ingredient in Its eCTD Solution.

Business Editors/Hi-Tech Writers

CHIPPENHAM, UK & PHILADELPHIA--(BUSINESS WIRE)--Sept. 23, 2002

ICH Signs eCTD Step 4 Specifications - CDC's Solution Helps Clients

Achieve Mandate of Advanced Cross Referencing

CDC Solutions (CDC), (www.cdcsolutions.com), the leading global provider of document-based solutions to the life sciences industries, today announced Xref Manager as a key ingredient in its electronic Common Technical Document (eCTD) solution.

With the signed Step 4 eCTD specifications from the International Conference on Harmonization (ICH), CDC Solutions' Xref Manager plays a vital role in its eCTD solution due to an increased demand for advanced cross-referencing.

CDC's eCTD solution is the first and only product on the market that supplies all the functionality necessary to map the life cycle of the drug to the related documentation through an organization's Document Management System (DMS).

The eCTD is part of the ICH initiative to provide a common format for industry to agency transfer of regulatory information that is acceptable across the ICH regions of the United States, Japan, and the European Union.

This initiative is a key component of the primary ICH goal to facilitate a more economical use of human, animal, and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines.

CDC's Xref Manager works in conjunction with its eCTD solution to deliver the advanced cross-referencing capabilities necessary to accomplish the level of granularity critical to the life cycle approach to the submission.

Just this month, the ICH's working committee clarified that the requirements for the level of granularity, with respect to documents and files, has increased in the recently signed Step 4 specifications.

This call for an increase in documentation granularity will mean a much greater demand for the use of cross-references for easy navigation between electronic documents and files, as well as for the linking of amendments as the eCTD submission evolves over time.

"Much of the focus of the eCTD has been on the introduction of the 'XML backbone' into the world of electronic submissions. The 'XML backbone' provides the mechanism to record all interactions and highlights changes between submissions throughout the entire development of the drug," says Jim Cook, Chief Technology Officer at CDC Solutions. "But just as important, the documents in the submission must be easily navigated with advanced electronic cross-references - without them the life cycle approach would be lost. Xref Manager provides consistent inter-document and intra-document cross-referencing at the authoring level, in a controlled DMS environment to ensure the life cycle of the drug is mapped to the related documentation - even at the greatest level of document granularity," added Cook.

CDC's eCTD solution is included in the latest edition of the EZsubs'(TM) Submissions Manager. The latest version will be released on October 10, 2002 and will include the functionality recently specified in the ICH Step 4 document. CDC's technology and regulatory experts have contributed to the ICH on the development of the specifications for the eCTD.

In addition, CDC Solutions is working with high-level regulatory and IT professionals from global life sciences companies to continually enhance its eCTD solution.

This valuable customer input, coupled with close development of the EZsubs Submissions Manager with ICH specifications, has resulted in a flexible, easy-to-use eCTD solution to help ensure organizations transition smoothly into the future of electronic submissions.

About CDC Solutions Ltd.

Founded in 1994, CDC Solutions is the leader in high performance document-based solutions to the Life Sciences industries. The open, flexible technologies developed by CDC Solutions enable Life Sciences companies to meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and data integrity to deliver reports and submissions reliably on time.

CDC Solutions helps compress the regulatory submissions and approval process, improving speed to market, cost control, and productivity: all of which contribute to ensuring patients' and physicians' timely access to new drugs.

CDC Solutions develops products in-house, employing a team of developers and regulatory specialists who actively pilot new initiatives with clients and partners. Through its strategic business partners, CDC Solutions' technology is used to address the needs of other document intensive industries such as engineering, utilities, and finance.

For more information, call [phone] (United Kingdom) or +1 610.834.9021 (CDC Solutions Inc., North America), or visit the CDC Solutions website at www.cdcsolutions.com.

CDC Solutions, CDC Solutions Inc., EZsubs Publishing Suite, PDFfusion, PDFrender, PDFaqua, PDFtools, PDFcontrol, Xport and Xtensia are trademarks or registered trademarks of CDC Solutions Ltd. All other product and company names mentioned herein are trademarks of their respective holders.