ISI's SaaS Approach to eCTD Submissions Helps Boehringer Ingelheim Meet FDA Submission Requirements in Record Time: -- ISI's approach to eCTD submissions software delivery allowed company to move quickly with a Software-as-a-Service hosted solution

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Image Solutions, Inc. (ISI), a leading provider of software and services to streamline the drug development and regulatory approval process, today announced that world-leading global pharmaceutical group Boehringer Ingelheim has deployed eCTDXPress - the company's flagship solution for managing and reviewing electronic submissions - via a Software-as-a-Service (SaaS) hosted model. The process from selection to implementation and validation took just under eight months.

This was a very impressive collaboration

    Based on Boehringer Ingelheim's decision to procure the software using the SaaS model, the company was able to comply with the electronic Common Technical Document (eCTD) format developed by the International Conference on Harmonisation. While many regulatory agencies are moving toward the eCTD-only format, the United States is the first to require electronic submissions in eCTD. As of January 1st 2008, the U.S. Food and Drug Administration (FDA) requires the eCTD format for electronic submissions, applicable for any pharma company targeting the U.S. market.

ISI offers a range of flexible solutions that address this need, comprising the relevant tools, global authoring templates, outsourced services, and software. Crucially, this can be 'purchased' as a hosted service, maximising speed of deployment, minimising the internal investment needed in infrastructure changes and skilled resources.

Headquartered in Ingelheim, Germany, Boehringer Ingelheim develops and produces pharmaceutical products for human and animal health that are usually submitted for regulatory approval across the globe, with particular interest in the most important territories Europe, Japan and the USA. The latter consequently required their electronic submissions activities to be compliant with the new FDA regulations.

One of the crucial decision factors in finding the most appropriate software solution was whether it could be provided on a flexible SaaS basis. Boehringer Ingelheim had given itself until December 2007 to successfully implement the new solution, precluding an in-house system that would require extensive integration and validation - and an entire team to be assembled to manage and support the technology.

The project started in April 2007 and was delivered on time by December 2007. "This was a very impressive collaboration," says Gilbert Kampfner, Managing Director of ISI Europe. "Nobody had to push back the timelines; everything was ready on schedule. Furthermore, choosing a SaaS solution allowed Boehringer Ingelheim's internal support costs to be cut by approximately 40 percent and this resulted in considerably lower overall costs than a potential in-house solution."

Since first deploying ISI software for supporting electronic submissions over five years ago, Boehringer Ingelheim has cut at least two weeks from the submissions cycle. For a blockbuster drug worth 1 billion euros a year, a two-week time-to-market acceleration is worth a lot.

Boehringer Ingelheim confirmed that it has been a very smooth collaboration with a rapid rollout and the timelines speak for themselves.

Tags: FDA compliance; eCTD; electronic submissions; medical writing; drug development; drug development technology; pharmaceutical industry; software-as-a-service (SaaS); application service provider (ASP).

Suggested Links: ISI; Boehringer Ingelheim; FDA eCTD Guidance

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 750 eCTD submissions. The company has a 42 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 http://www.imagesolutions.com.

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Lisa Meyer
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