Whippany, NJ (October 18, 2005) – Image Solutions, Inc. (ISI) announced the latest release of eCTDXPress® 2.2 software in conjunction with their annual eSolutions Conference in Paris, October 18-19. eCTDXPress® 2.2 is a web-based software solution that reflects ISI’s latest efforts in providing a complete solution for the lifecycle management, review and archiving of eCTD’s (Electronic Common Technical Document). The eCTD standard is a globally accepted document structure being ardently promoted as the emerging standard by both the FDA and the European Union for new drug submissions.
Intended for pharmaceutical and biotechnology organizations that require an intuitive, streamlined system for creation and lifecycle management of multi-region eCTD regulatory submissions, eCTDXPress® 2.2 easily integrates with existing electronic document management systems (EDMS), and can also function as a stand-alone eCTD solution. Either configuration affords users the ability to move from their current paper CTD or eNDA process to the latest eCTD standard with security and ease.
eCTDXPress® 2.2 is comprised of three (3) integral components, eCTDXPress Manager, eCTDXPress™ Compiler and eCTDXPress Reports. eCTDXPress Manager provides a central repository for all eCTDs, and allows organizations to import, view, and collaborate on the review and internal approval of any eCTD. It also allows users to display multiple documents simultaneously, share comments, manage broken hyperlinks and validate eCTDs before sending them to an agency. eCTDXPress™ Compiler allows publishers to easily create the original eCTD application and maintain lifecycle updates. Compiler also contains many robust features like an XML backbone wizard, web-based link management, automatic MD5 checksum generation, eCTD cloning, study tagging file management, all which dramatically simplify compiling a submission built according to DTD and agency specifications. eCTDXPress Reports provides a flexible environment to present custom reports and to produce submission tracking information against both EDMS and eCTDXPress information.
The 2.2 release of eCTDXPress also boasts Study Tagging File (STF) automation in compliance with both the International Conference on Harmonisation (ICH) and the U.S. Food and Drug Administration (FDA) specifications. Enhanced EDMS integration provides for maximum reuse of attributes already existent in the Document Management System (DMS), thereby increasing the Return on Investment for the DMS and providing minimal user redundancy. These most recent enhancements have been added to provide a seamless integration with First Consulting Group’s (FCG) FirstDoc® R&D Content Management Solution, resulting in a complete end-to-end solution for submissions, and an ability to create, review archive and manage entire eCTD submission lifecycles, down to individual document granularity.
Like earlier versions, eCTDXPress® 2.2 deploys easily, requiring minimal training, and can be scaled to meet the needs of any size organization. By eliminating many of the manual tasks required to build an eCTD, eCTDXPress® 2.2 streamlines the preparation effort within organizations, and dramatically accelerates eCTD distribution, review, validation and acceptance of submission formats by regulatory agencies worldwide and expedites marketing approval. The web-based component of eCTDXPress® 2.2 facilitates global eCTD submissions, and allows organizations to focus on drug development content rather than on eCTD structure.
For more information on eCTDXpress® 2.2 please visit ISI’s website at: http://www.imagesolutions.com/software/ectdxpress