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ISI Leverages Its 40% eCTD Market share Among Top 50 Pharma To Offer Competitively Priced Solutions for Middle Market and Emerging Companies

Eschborn, Germany – November 15th, 2007 – Image Solutions, Inc. (ISI), a leading provider of software and services to streamline the drug development and regulatory approval process, today unveiled its strategy to deliver packaged regulatory compliance solutions and services to emerging and mid-market life sciences organisations at the 6th Annual Electronic Submissions Conference hosted by the Drug Information Association (DIA).

With January 1st , 2008 set as the date when the U.S. Food and Drug Administration (FDA) requires the electronic Common Technical Document (eCTD) format for electronic submissions, European companies planning to make a submission in the USA in 2008 are faced with a number of strategic decisions. These decisions relate to the approach the company will take and the level of investment the company will make in building infrastructure and training employees on the guidance and its requirements.

Recognising that there are numerous paths a company can take, ISI is offering a flexible solutions package that combines tools, global authoring templates, outsourced services, and software available using various implementation options. ISI provides opportunities for staggered, buy-as-you-need purchasing. For organisations that want to build a submissions infrastructure using internal staff, ISI is tightly packaging its publishing software with best-of-breed document management systems (DMS) to enable companies to purchase one solution that has the required features and functions to manage documents and have them seamlessly flow into a publishing solution. The packages will be delivered so organisations can incrementally add functionality and solutions over time without having to settle for less robust functionality. In the coming weeks, ISI will be announcing expanded strategic relationships with several best-of-breed DMS providers.
Validating its approach to market, earlier this year ISI conducted focus groups around the country, including San Diego, to understand the unique dynamics impacting this market segment.

According to San Diego participants, a company’s business model will drive its approach to regulatory compliance, and will be the determining factor whether capabilities are developed internally, whether they outsource, or whether they leverage a partner such as ISI to provide skilled resources when they have a milestone event like an NDA.

“Regulations such as the eCTD are driving fundamental industry change, forcing companies to set their business priorities in the context of the compliance-driven environment in which they operate,” said Sue Simpson, managing director of West Coast operations for ISI. “Decisions whether to buy software or outsource are often dependent on a number of factors, including the number of compounds in development, stage of development, business model, or whether the company is partnering with a large pharma company that has already invested in software,” continued Sue. “We’ve also found that even if a company does not have plans to take a drug through to NDA, they still want to have their documentation in the eCTD format – a critical benefit to big pharma partners that may in-license a compound at a later stage.”

Sirion Therapeutics, an ophthalmic biopharmaceutical company with a San Diego-based state-of-the-art research and development facility, began working with ISI after its regulatory submissions team began putting in place a cradle-to-grave electronic data management and regulatory submission workflow that would take advantage of eCTD efficiencies and prepare the company for future growth.

“As an emerging company with a relatively small regulatory operations staff, Sirion needed a tool that would be easy to use and easy to expand as the company and technology evolved over time,” said Lisa Butler of Sirion Therapeutics. “As we looked to the future and the evolving regulatory landscape, we recognised that a scalable solution would be an integral part of meeting our benchmarks and bringing new products to market efficiently. We partnered with ISI to not only gain access to their technology, but to remain competitive by gaining access to industry experts and making the most of evolving trends and best practices. This meant we needed a vendor partner who was driving the learning curve and keeping up-to-date on the latest industry and regulatory changes.”

ISI’s strategy for the emerging and mid-market sectors is to offer these organisations a broad range of options for managing all of their product-related information so that it is organised, searchable, and easily configured for regulatory submissions. Content and data can be structured according to the organisation’s needs and resources, leveraging any combination of four approaches:

• Buy: Companies purchase ISI software to manage information and create compliant regulatory submissions. ISI provides services, including ongoing training, to ensure the system is being used to its full potential.
• Rent: The Application Service Provider (ASP), or Software as a Service (SaaS) model, where ISI provides a hosted service accessed over the web, eliminating the need for internal software administration and IT support. This model has gained popularity for its quick deployment and pay-as-you-use fee structure.
• Outsource: ISI serves as a regulatory operations team to which an entire submissions function or portions of the process, such as medical writing or Case Report Form processing, is outsourced. With a full suite of outsourcing services, ISI can serve as a total submissions partner.
• Blend: Blend internal capabilities and team members with ISI skills and resources to support short-term submission peaks. Whether a submission is electronic or paper, ISI has the resources to facilitate the process. This is also appealing for organisations that have purchased ISI software but are making a first-time eCTD submission and require the knowledge base.

Editors’ Note: ISI’s will be exhibiting at booth #11 at the 6th Annual Electronic Submissions Conference. ISI leadership is also contributing to a number of the conference sessions and presentations.

About Image Solutions
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 nearly 1,200 electronic submissions and 550 eCTD submissions. The company has a 40 percent market share among Top 50 global pharmaceutical for its flagship submission product, eCTDXPress.

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 recognised charitable organisations. For more information, visit the company website at

PR Contact
Carina Birt, Sarum
PR for ISI Europe
+44 1722 411150

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