PRTODAY / NewswireToday Free press release distribution service network

More news: Software
Written by / Agency / Source: Intrasphere Technologies, Inc.

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

Intrasphere Technologies Releases PharmaCM Submissions Management and Authoring Module - Powered by Microsoft Office SharePoint Server 2007, the solution created specifically for life sciences organizations simplifies the creation, review and preparation of regulatory content for submissions
Intrasphere Technologies Releases PharmaCM Submissions Management and Authoring Module

 

NewswireToday - /newswire/ - New York, NY, United States, 2008/02/08 - Powered by Microsoft Office SharePoint Server 2007, the solution created specifically for life sciences organizations simplifies the creation, review and preparation of regulatory content for submissions.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Software Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Intrasphere Technologies, a leading consulting firm that provides business-focused services and solutions to life sciences organizations, recently announced 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 (intrasphere.com) is a consulting firm focused on the Life Sciences industry. We provide comprehensive, business-focused services that help companies achieve meaningful results. Our professionals leverage strategic acumen, deep industry knowledge and proven project execution abilities to deliver superior service that builds true business value.

Our strategy, business process and technology services are developed to specifically address areas that are most important to our clients including; Drug Safety, Business Intelligence, Enterprise Content Management, Compliance and IT Management, to name a few.

We understand the unique nature of the Life Sciences working environment and clients' need to reduce costs, drive business processes and speed-to-market, while satisfying regulatory mandates.

Some of the world's leading global companies including Pfizer Inc., Johnson & Johnson, Novartis, Eli Lilly, Vertex Pharmaceuticals and HarperCollins Publishers, 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.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Software Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: Intrasphere Technologies, Inc.

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 
Software Warnings - IMPORTANT:
Always be aware/cautious about what you download on your computer/mobile! PURCHASE SOFTWARE related keywords / Banner Ads. Click HERE for details!
.

 
  Your Banner Ad showing on ALL
Software articles,
CATCH Visitors via Your Competitors Announcements!


Intrasphere Technologies Releases PharmaCM Submissions Management and Authoring Module

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

|
Publisher Contact: Annette DeCicco - Intrasphere.com 
212-937-8213 annette.decicco[.]intrasphere.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Intrasphere Technologies, Inc. securities in any jurisdiction including any other companies listed or named in this release.

Software via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From Intrasphere Technologies, Inc. / Company Profile


Read Software Most Recent Related Newswires:

IBM Debuts Blockchain Ecosystem to Help Accelerate Growth of Networks on Hyperledger Fabric
Permanent TSB to Improve Contact Centre Performance and Compliance with Noble Systems Composer Real-Time Speech Analytics
Rush Health Selects InterSystems HealthShare to Integrate Health Records, Support Value-Based Care
IBM Launches New Bluemix Services with GitHub and Slack Integration to Speed App Development in the Cloud
Yellowfin Launches Analytics Industry’s First Virtualized Integrated Data Preparation Module
TIBCO Releases TIBCO Mashery Local API Management Solution for Hybrid Gateway Deployments
Comways and Altitude Highlight Flexible Solutions at Belgium Contact Center Congress
Gruppo Campari Chooses OpenText Business Network for B2B Growth
Infor Delivers Enhanced Mobile Equipment Solution
Mentor Graphics and SiliconIndia Announce 2016 Leadership Awards for the Embedded/VLSI Industry
Korean Retailer Homeplus Optimizes Store Planning with JDA Category Management
IBM and Pfizer to Accelerate Immuno-oncology Research with Watson for Drug Discovery
The VELUX Group to Drive Smart Product Innovation with Implementation of PTC Windchill Across the Enterprise
KPIT Takes A Strategic Stake in A Germany Headquartered Automotive Engineering Services Company
Pegasystems Named Silver Winner for Best New Product of the Year in Best in Biz Awards 2016

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  La Bella Bakery Artisan Bakery Arizona

Visit  JobsWare.com





 
  ©2016 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)