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.
- 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.