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News

Regulatory submissions using MS SharePoint

Image Solutions : 24 March, 2009  (New Product)
Image Solution's regulatory suite now integrates fully with Microsoft SharePoint Server for improved submissions capability
Image Solutions (ISI) has expanded its relationship with Microsoft to offer a SharePoint-based solution for regulatory submissions.

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.

ISI's integration with Microsoft Office SharePoint Server improves organisational 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 utilise 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 utilise functionality across both platforms," said Adam Sherlock, ISI Europe's managing director. "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.

"Life sciences companies are facing major challenges in the area of research, discovery and development," said Rüdiger Dorn, managing director, Worldwide Pharmaceutical Industry. "By driving innovation through collaboration, Microsoft and its partners can help pharmaceutical companies bring products quicker to the market while still following strict compliance rules. Together with our partner ISI, we are developing solutions using Microsoft Office SharePoint Server's familiar, easy-to-use and widely supported platform to help life sciences firms increase the speed and efficiency of regulatory submissions."

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