New EMC Documentum Submissions Manager to Help Speed New Drug Applications
Leverages EMC Documentum Enterprise Content Management Platform to Ease Management, Assembly and Delivery of Drug Applications to Regulatory Agencies
PHILADELPHIA-Tuesday, February 7, 2006, EMC Corporation, the world leader in information management and storage, today announced the new EMC Documentum Submissions Manager for eCTD. Available immediately, the new software is based on the EMC® Documentum® enterprise content management platform (ECM), providing a solution to help life sciences organizations speed new drug applications. It is designed to support the regulatory submissions process for the Electronic Common Technical Document (eCTD) standard, which is a specification for the exchange of data between life sciences companies and regulatory agencies. EMC will demonstrate the Documentum Submissions Manager for eCTD software in Booth #24 at the 19th Annual DIA Conference for Electronic Document Management, Feb. 7-10, 2006, in Philadelphia.
The new software helps companies streamline the entire regulatory submissions process—from the departmental creation of content and submission-ready approvals, to assembly, validation, publishing and delivery to agencies. Documentum Submissions Manager for eCTD offers robust enterprise content management features. These features also help it serve as an important component in the enterprise compliance infrastructure of life sciences companies.
“The EMC Documentum Submissions Manager for eCTD includes all the necessary components to enable submissions teams to centrally store and share content, control workflow processes and enforce standards by which electronic submissions are assembled, reviewed, approved and published,” said Sankar Ramakrishnan, Lead Database Architect, AstraZeneca. “The EMC software offers help to life sciences organizations seeking to improve submission efficiency and accelerate the turnaround for review and approval with global regulators.”
Typically, new drug application submissions can encompass more than one million pages of content, including summary and clinical study reports that must be submitted to multiple regulatory agencies around the world. Managing this costly and labor-intensive process can lead to lengthy approval delays as life sciences organizations attempt to bring new therapeutics to market. Delays in the submittal process can result in the loss of millions of dollars per day in sales revenues, depending on the drug.
“Bringing new therapeutics to the global market continues to be challenging, given the vast amounts of information required by regulators,” said John Hanrahan, Director of Life Sciences Industry, EMC Software Group. “The EMC Documentum Submissions Manager for eCTD is designed to give life sciences organizations a more logical, automated tool to track, manage and assemble new drug applications while helping them adhere to eCTD requirements, improve operational efficiencies and achieve lower total cost of ownership.
“By combining this product with an EMC tiered network storage infrastructure, life sciences organizations can also implement an information lifecycle management (ILM) strategy to store, manage, protect and share critical regulatory submissions data as information value and regulatory demands change,” Hanrahan added.
The Documentum Submissions Manager for eCTD enables companies to manage the entire regulatory publishing process seamlessly – all from within the same Documentum enterprise content management platform. It is designed to guide life sciences organizations in the creation, management, assembly and delivery of controlled content to regulatory agencies in conformance with international standards for electronic submissions.
Developed on top of the Documentum ECM platform, the Documentum Submissions Manager for eCTD software works in tight coordination with the following:
* Authoring Integration Services—a new software component that supports Adobe Acrobat and Adobe Reader integration for creating, manipulating and navigating PDF hyperlinks.
* Regulatory Publishing Transformation Services—a new software component that automatically renders submissions documents to support advanced PDF publishing capabilities such as merging, volumization, table of contents creation and stamping.
* Trusted Content Services—providing secure information features such as electronic signatures, encrypted file storage and digital shredding.
The new Documentum Submissions Manager for eCTD software is a natural extension to customers’ information lifecycle management strategies. When combined with EMC’s high-performing, highly reliable and flexible tiered networked storage platforms and storage management software, life sciences organizations can store, manage, protect and share important new drug application content based on the enterprise’s unique business and regulatory compliance rules.
The Documentum Submissions Manager for eCTD is available immediately. Because of the extensible Documentum platform, users have the option to integrate other best-of-breed products from third parties to enhance the Documentum Submissions Manager for eCTD functionality to, for example, perform XML authoring or to handle all paper-based submissions. Additional product information, including a pre-recorded audiocast on the Documentum Submissions Manager for eCTD can be found at:
EMC Corporation (NYSE: EMC) is the world leader in products, services and solutions for information storage and management that help organizations extract the maximum value from their information, at the lowest total cost, across every point in the information lifecycle. Information about EMC’s products and services can be found at www.emc.com.
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