Publishing Software enables hybrid eCTD submissions.
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Press Release Summary:
ISIPublisher® helps Life Sciences companies with FDA electronic common technical document (eCTD) transition by supporting hybrid submissions still accepted by regulatory agencies. Able to handle diverse hybrid submission requirements of regulatory agencies worldwide, solution supports varying electronic submissions and also fulfills paper requirements. Via built-in templates or from scratch, solution lets users publish reports, submissions, or any electronically available documents.
Original Press Release:
Image Solutions Enables Hybrid Submissions with New Version of ISIPublisher®
Product Eases eCTD Transition by Supporting Hybrid Submissions Still Accepted by Many Regulatory Agencies
WHIPPANY, N.J. and ATLANTA, June 18 - In the lead up to the FDA's electronic common technical document (eCTD) 2008 deadline, Life Sciences companies are pushing toward compliance only to come up short on a solution that handles the complex and diverse "hybrid" submission requirements of regulatory agencies around the world. Image Solutions, Inc. (ISI), the clinical and regulatory submissions software and services company, is helping Life Sciences companies meet the standards for the eCTD set by regulatory agencies in the United States, Japan, and European Union (EU) nations, while responding to shorter-term requirements to publish in other electronic formats.
Although the term "hybrid" may have different meanings to varying organizations, the term commonly refers to an electronic submission that is not an eCTD or item-based legacy electronic submission. In Europe, several organizations are referring to similar submissions as NeES or non-eCTD electronic submissions. These hybrid - or NeES submissions - provide companies with the benefits of an electronic review, yet are not as complex or carry the same commitments for submissions moving forward as eCTD.
To provide the greatest flexibility and meet the agency requirements of multiple regulatory agencies, ISI released its newest version of ISIPublisher. The new version improves upon an industry-leading solution that helps support these varying electronic submissions, as well as fulfill the paper requirements for countries that still require paper submissions along with - or in conjunction with - an electronic submission. Hybrids do not have an XML backbone as required by the eCTD, but instead have a PDF-based table of contents which ISIPublisher automatically generates from an outline, existing XML backbone or PDF bookmarks.
With eCTD targeted for acceptance in the EU by 2009 and Canada currently accepting hybrid submissions, companies need flexible systems that allow them to move toward full eCTD submissions in stages. Particularly in Europe, companies are looking for a solution that supports a "middle ground" approach to the eCTD, whereby they begin to achieve all of the review and business process benefits of the eCTD but are not faced with an all-or-nothing proposition of moving to eCTD.
ISIPublisher is best suited to support the staged-approach because it enhances and streamlines paper-publishing operations and enables users to publish reports, submissions, or any electronically available documents that require professional printing. In addition, ISIPublisher not only supports hybrid submissions, but allows companies to reuse a submission for other submission formats: For example, companies can easily convert an eCTD to a paper CTD for Europe or "Rest of World". A similar process may be used to convert an eCTD to hybrid electronic submission.
ISIPublisher is the second application to be migrated onto the ISI Solutions Platform, an integrating technology framework that leverages industry-standard Microsoft .NET. The Solutions Platform offers the best aspects of a Web-based system with the rich client experience of traditional applications. The application's ability to produce full submissions and publications with a hyperlinked PDF table of contents offers companies' hybrid submissions in a format that they can use now, while being able to build toward a future strategy that includes eCTD.
"In moving toward new eCTD standards, companies are finding their progress slowed because each country around the world is at a different stage of being able to accept submissions in the eCTD format. Further, many companies may not be ready for the once-eCTD, always eCTD guideline imposed by some regulatory agencies," said Paul Chung, Senior Vice President of ISI Software & Services Operations. "When companies purchase ISIPublisher, they are investing in a total regulatory solution that allows them to build from their investment instead of entirely replacing a system that will accommodate the eCTD."
Companies can easily produce required publications using ISIPublisher's templates, or from scratch, by simply dragging and dropping electronic documents in a variety of formats. Within the publication, users can organize documents and create new hyperlinks. ISIPublisher creates a full table of contents as a separate PDF document that includes hyperlinks to each individual document within the publication.
For companies already preparing full electronic documents such as eNDAs, eBLAs, and eCTDs, ISIPublisher allows them to simply import their electronic files to create the properly formatted paper dossiers required by various agencies.
For more information about ISIPublisher or any of ISI's products, visit Booth #445 at the DIA Annual Meeting, June 17-21, or go to www.imagesolutions.com.
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 firm to deliver electronic submissions to the industry and since has delivered nearly 1,000 electronic submissions and 400 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 charitable over 20 recognized charitable organizations. For more information, visit the company Web site at www.imagesolutions.com
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.
