Image Solutions, Inc. | Press Releases

Image Solutions and NeurogesX Successfully Complete 1st eCTDXPress Aspire™ Implementation

Whippany, NJ (July 27, 2006) - Image Solutions Inc., (ISI) a global technology company and a leader in providing software solutions and services for electronic regulatory document submission and clinical trials management, announced today the successful completion of their first eCTDXPress Aspire™ implementation for NeurogesX, a privately held, emerging pharmaceutical company based in the San Francisco Bay Area. eCTDXPress Aspire™ is ISI’s “out of the box” eSubmission solution designed specifically for growing Biotech and small Pharmaceutical organizations that need to file electronic submissions such as Investigational New Drugs (INDs), Biologic applications (BLAs), New Drug Applications (NDAs), abbreviated NDA’s (aNDAs), New Drug Submissions (NDS), and Marketing Authorization Applications (MAAs) in the electronic Common Technical Document (eCTD) format.

Oftentimes, smaller, growing biotech and pharmaceutical organizations have limited budgets, Regulatory Operations staff, and IT support required to implement, validate, and maintain an in-house eSubmissions infrastructure. eCTDXPress Aspire™ provides multiple advantages for smaller biotech and pharmaceutical organizations by providing an ability to create and manage submissions in-house and ensure that their system will be professionally implemented and fully validated. According to Mark Bradin, Manager of Regulatory Publishing at NeurogesX, “ISI took the risk, worry and work out of implementing an in-house eCTD system, and allowed our scientific professionals to instead focus on their core competencies of drug development.” The system’s software was installed and validated by ISI at their headquarters in Whippany, New Jersey, and then the server was shipped to San Francisco where network integration, OQ and validation were completed.

Designed for small companies anticipating future growth, eCTDXPress Aspire™ is fully scalable and can be expanded as their company grows. Additional benefits include the ability to manage submission lifecycles, on-site maintenance support from ISI, and the availability of dedicated ISI consultants for regulatory operations submission assistance to ensure a successful pilot and submission. Many of the early adopters of this bundled solution are also finding it to provide an excellent opportunity for their in-house publishing staff to gain valuable knowledge and in-house experience about building submission ready eCTDs in anticipation of upcoming submissions.

Jinsoo Kim, ISI’s CEO states “ISI has always supported the smaller pharma and biotech companies by providing low cost and reliable software and outsourcing solutions for the smaller Life Sciences firms. With the adoption of the the eCTD formatted submissions in the US, Europe, Canada and Japan, we feel this packaged solution is exactly what the smaller pharma and biotech companies need to file successful submissions, backed by ISI’s 14-year submission experience.”

The eCTDXPress Aspire™ package includes eCTDXPress 2.3 software that is fully installed and validated on a server, on-site implementation by ISI, complete eCTDXPress training by ISI, submission and regulatory operations consulting, technical support for eCTDXPress software for one year, on-site maintenance, and on-going assistance by ISI to build the first pilot eCTD and submission. ISI will also provide on site staff augmentation to assist with the submission at the clients’ request.

ISI will conduct a series of educational seminars in September to introduce this new solution in several hotbed biotech regions including San Diego, San Francisco, Seattle, Boston, Maryland, and North Carolina. For more information about these seminars or to register, visit the ISI website www.imagesolutions.com

eCTDXPress® is ISI’s web-based solution for managing, compiling, reviewing, registering, and storing eCTD submissions. Created to satisfy both agency and sponsor needs, eCTDXPress® allows your organization to easily meet the regulatory requirements for eCTD submissions throughout the world, using key features that reduce eCTD submission challenges. eCTDXPressAspire™ includes eCTDXPress® Compiler, Web-based Link Management, and eCTDXPress® Manager. eCTDXPress® Compiler allows publishers to easily create the original eCTD application and maintain the lifecycle updates. Compiler contains many robust features that ensure a submission is built according to the DTD and agency specifications and is extremely useful when building the original eCTD, or providing new sequences to agencies. Many of ISI’s best hyperlinking plug-ins from ISIToolBox Pharma™ have also been incorporated in the Web-based Link Management feature of eCTDXPressAspire™ and finally, eCTDXPress® Manager provides a central repository for all your eCTDs and allows an organization to import, view, and collaborate on the review and internal approval of eCTDs.

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.