Image Solutions, Inc. | Press Releases

EMEA Chooses ISI's eCTDXPress Software For Pilot

Whippany, NJ (November 2, 2004) – Image Solutions, Inc. (ISI) announced today that it has been selected by the European Medicines Evaluation Agency (EMEA) as one of only three vendors asked to install electronic common technical document (eCTD) software for the European Review System (EURS) project. This project was initiated by EMEA to review the most preeminent eCTD software offerings for eventual installation and use by not only the EMEA, but thirty-two (32) National Competent Authorities (NCA’s) in twenty-five (25) European countries as well. EMEA’s selection of ISI was based on their ability to meet the original specifications defined as part of the EURS project, and their ability to provide a flexible reviewing tool for users with varied computer proficiency.

The pilot program was designed to help bring to conclusion EMEA’s efforts to select one eCTD viewing tool to be used by NCA reviewers throughout the European Union when reviewing marketing applications submitted via the Centralized Procedure. The pilot affords NCA and EMEA reviewers the opportunity to gain hands-on experience with the functionality and navigation of eCTD submission tools. The pilot program is scheduled to continue through November 2005, when one software solution will be selected by EMEA and made available to all EU authorities. By selecting an electronic review tool like eCTDXPress, EMEA is hoping to facilitate the review process for marketing applications, eliminate redundancy, and make submission documents readily available to multiple reviewers simultaneously; all intended to inevitably get life-saving drugs to patients more efficiently and expeditiously. The eCTD is the International Conference on Harmonization (ICH) standard that is being ardently promoted as the emerging standard for new drug submissions worldwide.

eCTDXPress is ISI’s web-based eCTD submission software, designed to facilitate collaboration and review among regulatory agency reviewers, while at the same time permitting pharmaceutical manufacturers to efficiently compile and submit properly-formatted new drug submissions, as well as manage drug development lifecycles.

About Image Solutions, Inc.

Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firm to deliver electronic submissions to the industry and since has delivered thousands of submissions. The company has a 49 percent market share among Top 50 global pharmaceutical for its flagship submission product, eCTDXPress, and 4 of the top 10 pharma now have ISIPublisher.

ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognized charitable organisations. For more information, visit the company website at: www.imagesolutions.com.