ISI Adds Metadata Management to Regulatory Solution Suite : ISI Submission Manager provides at-a-glance management of products regardless of application format Process redundancies reduced for multi-region submissions

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ISI, a leading provider of software and services for the life sciences industry, today announced a new module to its integrated regulatory solution suite at the 2008 RAPS Annual Conference & Exhibition in Boston. ISI Submission Manager (ISM) targets metadata and the relationship between submissions, and allows regulatory teams to easily manage and transfer data between submissions and create powerful reports on submission status based on data from eCTDXPress and ISIPublisher, the company’s flagship products to manage eCTD, paper, and non-eCTD electronic submissions (NeES). The suite – which is now integrated through a single platform – allows users to manage all submission types and formats. The “one solution” approach allows companies to streamline submission cycles, reduce process redundancies and rework, and prepare submissions for new markets.

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This means users can seamlessly access, analyze and link content between applications and publications depending on information need, a function that is particularly relevant in today's marketplace.

ISM provides the point of integration between products on the ISI platform for assembling and managing. It includes two key components that enhance decision making and reduce redundancies for regulatory submissions teams at life sciences organizations. The first component allows users to access outline views for all of the eCTDXPress applications/submissions and ISIPublisher publications. The second, Metadata View, allows users to view hierarchy, Regional, ICH, STF and custom metadata associated with each application or publication, and allows real-time metadata modification for streamlined submission management. The metadata package of ISM will be available to clients as part of the initial release of the Suite.

The challenge for today's regulatory operations team is significant: With the electronic Common Technical Document (eCTD) as the standard format for submissions, products are being submitted in multiple regions and in multiple formats, creating administrative and reporting hurdles. "The ability to manage metadata should be front and center in every regulatory submission plan because it allows companies to track the metadata and therefore the relation between submissions, thus allowing easy access to and comparison of submissions and applications regardless if it they are eCTD, paper, or NeES," said Justin Hur, Head of R&D at ISI. "This means users can seamlessly access, analyze and link content between applications and publications depending on information need, a function that is particularly relevant in today's marketplace."

The ISI Regulatory Solutions Suite can be purchased as an end-to-end suite, or as standalone modular applications. ISM allows users to track documents through ISIPublisher or eCTDXpress, and comes with ISIPublisher 3.1 and eCTDXpress 3.2. Another key component of the ISI Regulatory Solutions Suite, ISIRegTracker, offers a comprehensive registration tracking and licensing management solution, completing the information management requirements of any Regulatory Operations/Affairs department.

"The updated Regulatory Suite will help the industry to face the challenge of today's regulatory electronic submission practice, which is solely a 'one-way' communication between the sponsor and an agency," said Jascha Minow, Director of Product Management for ISI. "The combination of ISM and ISIRegTracker will allow clients to keep the regulatory assembly, submission building and management processes in sync with the regulatory approval and licensing process. With one set of solutions, companies can effectively track and manage the entire regulatory submission process."

Tags: eCTD; regulatory submission; global submission; ICH; document management

Suggested Links: FDA eCTD Guidance; ICH Specification

Editor's Note: ISI will be exhibiting at the 2008 RAPS Annual Conference & Exhibition in Boston at Booth #508.

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 more than 1,600 electronic submissions and 1,000 eCTD submissions. The company has a 48 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 recognised charitable organisations. For more information, visit the company website at http://www.imagesolutions.com.

Image Solutions, Inc., ISIToolBox, ISIRender, Virtual Link Manager, 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

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Lisa Meyer
ISI
973-560-0808 x 217
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