Whippany, NJ (November 10, 2005) - Image Solutions, Inc. (ISI), and First Consulting Group (FCG) (NASDAQ: FCGI) today announced a strategic partnership agreement to integrate the companies’ flagship software products to respond to a marketplace need for a streamlined eSubmission tool. For the first time, life sciences companies will have a fully integrated product to prepare documentation and publish eSubmissions compliant with the industry’s electronic Common Technical Document (eCTD) standard.
Through the integration of ISI’s regulatory software application, eCTDXPress®, with FCG’s enterprise content management platform, FirstDoc®, companies will now be able to better manage the lifecycle of individual eCTD documents within the overall eCTD application lifecycle. The companies’ eConnector was designed to improve the consistency of drug information while helping pharmaceutical clients remain compliant with multiple regulatory agency standards across the globe.
“ISI and FCG have responded to the need to manage the realities of paper submissions along with the industry’s eCTD standard by developing one, stand-alone tool” said Jeff Klein, Vice President in FCG’s Life Sciences practice. “More than two thirds of FCG’s current FirstDoc customers will have an immediate need for the new product. One client is already strategically reengineering their processes to gain additional efficiencies in concert with this technology roll-out. This will enable them to optimally leverage the eConnector during this transitionary period, and plan for the submissions they will make electronically over the coming months.”
“Companies will now be able to see which documents have been used in which submissions by constructing a best-of-breed framework that blends regulatory submission assembly and content management” said Paul Chung, Vice President of ISI’s Software Business Unit. “The combined ISI/FCG solution is a powerful eConnector between the companies’ products, solving long-standing problems that arise when collecting documentation from document management systems and transferring to publishing tools. By seamlessly bringing together our technology, we’ve solved one of the most critical industry issues today.”
The eCTD format is the globally accepted electronic submission standard for new drug submissions to the U.S. Food and Drug Administration (FDA), the European Medicines Evaluation Agency (EMEA) and the Japanese Ministry of Health, Labor and Welfare (MHLW). Without technology that enables eCTD submissions, companies must create different versions of the same submission for each agency to which they submit.
Integrating eCTDXPress and FirstDoc for the Electronic Common Technical Document (eCTD)
eCTDXPress is ISI’s web-based software solution that provides comprehensive product submission lifecycle management, submission assembly collaboration and eSubmission storage of a pharmaceutical manufacturer’s application documents in the eCTD format. FirstDoc provides specific document types and subtypes, each with their own set of predefined properties and a design that reflects current International Conference on Harmonization (ICH) guidelines and easily facilitates eCTD submissions. Together, eCTDXPress and FirstDoc provide users with a tool that not only creates and publishes eCTD submissions, but provides a range of document types, at the level of granularity required by the eCTD, that will ultimately enable companies to generate submissions more rapidly and compliant with ICH and regional guidelines.