Navigation Links
Intrasphere Technologies Releases PharmaCM Submissions Management and Authoring Module Powered by Microsoft Office SharePoint Server 2007
Date:2/5/2008

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.

-- Configurable portal views and reports to generate both management and

operational level metrics to make improved management decisions leading

to more efficient submission projects.

-- Integrated submissions issue tracking tool to quickly resolve content

preparation issues within any node of the eCTD modules.

"We anticipate that submission content will continue to move toward a structured format, either within the eCTD standard or a future submission standard like RPS," said Woo Song, Co-Founder & Chairman, Intrasphere Technologies. "We have been working with XML and structured content for many years and it's always been a challenge to get users to become comfortable working in that environment. By building a Microsoft Office Business Application, we can now remove the complexities of XML authoring and tagging which will enable our clients to focus on efficient creation and management of submissions content, without having to learn new authoring and content management tools."

"Being able to submit documents in accordance with the FDA's rules is an obvious business-critical issue for any pharmaceutical company," said Michael Naimoli, U.S. life sciences industry solutions director, Microsoft Corp. "Companies are facing major transitions in their underlying business processes due to the new approach for eCTD. Intrasphere's PharmaCM Submission Management and Authoring solution, using Microsoft Office SharePoint Server 2007, provides firms with a seamless transition and unified way to manage and maintain the entire submissions lifecycle. This solution will enable our clients to not only meet current eCTD requirements, but also lay a long-term foundation to meet the ever-changing regulations and global demands for more structured content."

eCTD (Electronic Common Technical Document)

The eCTD standard developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG), is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format.

For more information about Intrasphere's PharmaCM Submissions Management and Authoring module, contact us at (212) 937-8200.

About Intrasphere Technologies

Intrasphere Technologies, Inc. (http://www.intrasphere.com) is a consulting firm focused on the Life Sciences industry. We provide comprehensive, business-focused services that help companies achieve meaningful results.

Some of the world's leading global companies including Pfizer Inc., Johnson & Johnson, Novartis, Eli Lilly and Vertex Pharmaceuticals, among others, look to Intrasphere as their trusted solutions partner.

Founded in 1996, Intrasphere is headquartered in New York City with operations in Europe and Asia. Intrasphere has been recognized nationally for performance by industry leading organizations such as, Deloitte & Touche, Crain's New York Business and Inc. Magazine.


'/>"/>
SOURCE Intrasphere Technologies
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Neurobiological Technologies Sets Date for Second Quarter Financial Results
2. Emisphere Technologies to Present at BIO CEO & Investor Conference on February 12
3. Vestibular Technologies Is Awarded Contract by Major Group Purchasing Organization (GPO)
4. Healthcare Technologies Ltd. Announces the Change of its Name to "NexGen Biofuels Ltd"
5. Genelabs Technologies, Inc. Announces Resignation of President and CEO
6. Millennium Biotechnologies Group Reports 40% Sales Increase for Resurgex Product Line in Greek Market
7. Arbor Surgical Technologies Announces Series C Financing and Licensing Agreement with Medtronic
8. Neptune Technologies receives GRAS notification in the United States
9. VNUS Medical Technologies to Report Fourth-Quarter 2007 Results and Webcast Teleconference on February 7
10. Cardica and Intuitive Surgical to Host Educational Symposium on Advanced Techniques and Technologies in Robotic Coronary Revascularization and Mitral Valve Repair
11. Delaware Court Denies Motion by SIGA Technologies Seeking to Dismiss PharmAthenes Legal Action in Breach of Contract Lawsuit Against SIGA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... 2016 /PRNewswire/ - BioAmber Inc. (NYSE: BIOA ), ... that Mitsui & Co. Ltd., its partner in the ... is investing an additional CDN$25 million in the joint ... from 30% to 40%.  Mitsui will also play a ... in Sarnia , providing dedicated resources ...
(Date:2/10/2016)... York, New York (PRWEB) , ... ... ... Pharmaceuticals Inc. (NASDAQ: REGN) today announced that it has joined the Human ... and immunotherapies for infectious diseases and cancer. , The Human Vaccines ...
(Date:2/10/2016)... ... 10, 2016 , ... HOLLOWAY AMERICA, a leading custom stainless ... Mountain Chapter 21st Annual Vendor Exhibition on Thursday, February 18, 2016. The Rocky ... its annual event, which will run from 3:00 p.m. - 8:30 p.m. at ...
(Date:2/10/2016)... ... February 10, 2016 , ... Global Stem Cells ... with Singapore-based Global Stem Cells Network (GSCN) and its affiliate Global Medical ... the latest adipose and bone marrow therapies. , Through the new collaboration, ...
Breaking Biology Technology:
(Date:2/1/2016)... , Feb. 1, 2016  Wocket® smart wallet ( www.wocketwallet.com ) announces ... personality, Joey Fatone . Las Vegas , ... --> Las Vegas , where Joey appeared ... The new video ad was filmed at the Consumer Electronics Show ... the Wocket booth to meet and greet fans. ...
(Date:1/25/2016)... SEATTLE , Jan. 25, 2016  Glencoe Software, ... biotech, pharma and publication industries, will provide the data ... Phenotypic Screening Centre (NPSC). ... Phenotypic analysis ... even whole organisms, allowing comparisons between states such as ...
(Date:1/20/2016)... Jan. 20, 2016 A market that just ... benefit from the explosion in genomics knowledge. Learn all ... Research. A range of dynamic trends are pushing market ... personalized medicine - pharmacogenomics - pathogen evolution - next ... markets - greater understanding of the role of genetic ...
Breaking Biology News(10 mins):