Image Solutions, Inc. | Press Releases

Elan Pharmaceuticals Selects Image Solutions, Inc’s eCTDXPress for Managing Global eCTD Submissions

Whippany, NJ (March 28, 2005) – Image Solutions, Inc. (ISI) announced today that Elan Pharmaceuticals, Inc. will install its web-based software, eCTDXPress, in San Diego, California to manage Elan’s global eCTD (Electronic Common Technical Document) drug submission lifecycles.

eCTDXPress is a web-based software solution that provides comprehensive compilation, lifecycle management, collaboration and storage of eCTD submissions . The eCTD is the globally accepted electronic submission structure developed under International Conference on Harmonisation (ICH) that is emerging as the standard for electronic drug submissions to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the Japanese Ministry of Health, Labor and Welfare (MHLW).
eCTDXPress is comprised of two integral components, eCTDXPress Manager and eCTDXPress Compiler. eCTDXPress Manager provides a central repository for all eCTDs, allowing organizations to import, view, and collaborate on the review and internal approval of any Marketing Application in eCTD format. It also allows users to display multiple documents simultaneously, share comments, and validate eCTDs before sending them to regulatory agencies.

eCTDXPress Compiler allows publishers to easily create an original eCTD application and create lifecycle updates for existing eCTD submissions. Compiler also automates creation of many technical components of the eCTD, such as the XML backbone, MD5 checksums, and Study Tagging File (STF), all dramatically simplifying the assembly of a compliant submission built according to document type definition (DTD) and agency specifications. For more information on eCTDXPress please visit ISI’s website at:
http://www.imagesolutions.com/software/ectdxpress.

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.