ISI Builds Solution to Streamline Regulatory Submissions for Pharma Industry on Microsoft Software Platform

PHILADELPHIA--(EON: Enhanced Online News)--ISI, a leading provider of software and services to streamline the regulatory approval process in the life sciences industry and Microsoft Gold Partner today announced it has expanded its relationship with Microsoft to offer a SharePoint-based solution for regulatory submissions. The announcement was made at the Drug Information Association conference on Electronic Data Management (ISI Booth #407-409). Through the integrated solution, ISI’s Regulatory Solutions Suite – which includes ISI’s flagship products eCTDXPress and ISIPublisher – is now built upon and seamlessly integrates with Microsoft Office SharePoint Server 2007, offering several powerful new features that remove administrative burdens from regulatory departments to accelerate timelines for taking drug therapies to market.

“Enabling the Networked Pharma Model Through Collaborative Work Spaces”

ISI’s integration with SharePoint Server improves organizational effectiveness by providing comprehensive control over electronic content, accelerating shared business processes and facilitating better decision making and information sharing within the enterprise and externally among partners. Through the integration, ISI will offer its clients optimal flexibility to utilize SharePoint Server as a base platform for managing regulatory content and/or a robust tool for drug development collaboration.

“ISI’s product portfolio has been built on Microsoft’s .NET Framework for several years, which makes the integration with SharePoint Server more seamless and allows us to more fully utilize functionality across both platforms,” said Jinsoo Kim, CEO and President at ISI. “SharePoint Server allows us to create a familiar collaboration environment that enables life sciences companies to easily deploy our proven solutions.”

SharePoint Server provides users the ability to control information rights, digitally sign key review documents in a SAFE-compliant manner, manage electronic Common Technical Document (eCTD) metadata or clinical trials documents, and publish to PDF and Microsoft XPS, the two leading electronic formats for regulatory submissions. By integrating ISI Regulatory Suite with SharePoint Server, publishers will be able to manage content in SharePoint Server and easily publish it to an eCTD, non-eCTD electronic submission or NeES, paper submission or other submission format.

“The major hurdles we are seeing to building truly collaborative environments are inconsistent content, inefficient workflows, and lack of integration between existing content management systems, workflows and collaboration tools,” said Michael Naimoli, U.S. life sciences industry solutions director, Microsoft Corp. “ISI’s vertical solution, built on SharePoint Server’s familiar, easy-to-use and widely supported platform, can help life sciences firms solve these issues head-on and increase the speed and efficiency of regulatory submissions.”

ISI’s integration with the SharePoint platform will be further described at a joint-hosted Webinar titled “Enabling the Networked Pharma Model Through Collaborative Work Spaces,” to be held at 2:00 p.m. EST/11:00 a.m. PST on Wednesday, February 25, 2009. Eric G. Brown, vice president and research director, Forrester Research will be presenting, along with Toban Zolman, director of consulting services, ISI. To register for the Webinar, please visit www.imagesolutions.com/ISIwebinar

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 firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organizations as well as the top companies in other regulated industries.

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 organizations. For more information, visit the company website at www.imagesolutions.com.

Tags: eCTD; regulatory submission publishing; electronic submissions; drug development; drug development technology; pharmaceutical industry; biotechnology; information technology; Microsoft

Image Solutions, Inc., ISIToolBox, eCTDXPress, ISIPublisher and ISIRegTracker are trademarks or registered trademarks of Image Solutions, Inc. which may be registered in the United States and internationally. Other brand names may be trademarks or registered trademarks of others.