Intrasphere Technologies Releases PharmaCM Submissions Management and Authoring Module Powered by Microsoft Office SharePoint S...( Solution created specifically for l...)

Solution created specifically for life sciences organizations simplifies the creation, review and preparation of regulatory content for submissions

NEW YORK, Feb. 5 /PRNewswire/ -- Intrasphere Technologies, a leading consulting firm that provides business-focused services and solutions to life sciences organizations, announced today that the company's "PharmaCM" structured content management solution powered by Microsoft Office SharePoint Server 2007 now offers a Submissions Management and Authoring module which will help clients create content and easily prepare for NDA submissions following eCTD standards. Users can now manage the complex process of planning, authoring, reviewing, approving and releasing content, to submission assembly of drug development information from a common portal.

Key features of the PharmaCM eCTD module are:

Structured Content Authoring and Collaboration:

-- Structured content management tools that enable users to easily create

and re-use content across various documents covering all five eCTD

submission modules. Creation of structured content templates following

industry standards including ICH, CDISC, and HL7.

-- Easy to use meta-data management tools which not only allow users to

track information about the document, but also allow meta-data to embed

directly in the document, enabling re-usable text elements.

-- Collaboration environments that integrate seamlessly with the users'

working environment. Creation of review and approval workflows,

enabling document discussions, and real-time document collaboration to

improve the content preparation life-cycle.

Submissions Management:

-- Submission planning for both regional and global submissions. Enabling

content re-use across regions, tracking content creation, target dates

and approvals for release to submissions assemblies.

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