The leading content management platform for Life Sciences organizations powered by Microsoft

The Opportunity
The process of developing pharmaceuticals and medical devices is an information intensive endeavor.  Companies face an enormous challenge in managing and harnessing the value of content contained in countless documents generated across a variety of departments throughout the product lifecycle.  Additionally, companies must comply with ever changing government agency regulations as well as to find new ways of reducing drug development costs and introduce products in a timely manner.

One of the biggest hurdles to implementing a content authoring and management solution has been the considerable effort to train users not only in new technology but also in a new approach to authoring documents.  Established authoring solutions for content management systems provide an unfamiliar environment with significant limitations in formatting documents, and a considerable difficulty in producing consistently formatted renditions in Microsoft Word and PDF formats.  Now, with the release of Office 2007, Microsoft has embraced XML technology and made it an integrated part of Word .  This means that authors can enjoy all of the standard easy-to-use Word features to format documents and collaborate with others. Then easily transform content into appropriate regulatory XML formats such as SPL, PIM as well as to CDISC, HL7 and ICH standards. 

Intrasphere Solution
Intrasphere helps companies address the challenges of regulated content management via PharmaCM.  The PharmaCM platform enables companies to streamline content creation and collaboration, convert content into actionable information, improve the ability to meet and answer regulatory needs, as well as transform content into appropriate regulated standards.  Using the OpenXML standard along with MOSS-based artifacts and assemblies, PharmaCM provides an innovative, yet easy to use content management solution providing:

• Structured content management and embedded meta-data to improve content re-use
• Enhanced document collaboration, content reviews and approvals
• Tagless XML authoring

PharmaCM is composed of three different modules helping clients meet current and emerging regulatory content management challenges:

• Clinical Trial Registration:   PharmaCM’s Clinical Trial Registration module helps companies not only gather accurate clinical trials information, but to manage the complex process of authoring, reviewing, approving and uploading study content to ClinicalTrials.gov.  Users can easily establish appropriate workflows and management alerts to help avoid delays or inaccurate content posting to the registry.  Learn More
  
• Submissions Planning and Authoring: Plan, track and author product submission content in accordance with eCTD standards.  Manage global submission projects and gain insight into how content is re-used and leveraged across regional submissions.  Manage the complex process of planning, authoring, reviewing, approving and releasing content to submission assembly of drug development information from a MOSS-based portal.  Learn More
  
• Structured Product Labeling:  Intrasphere’s Product Labeling module provides an easy to use label authoring environment to create heavily formatted printed labels (USPI, PLR, PPI) and leverages the power of OpenXML to convert the printed labels into the electronic label format (SPL).  This solution includes an intuitive tagless authoring solution such that non-narrative information can be associated with the printed labels for proper electronic label generation.  Also included are GUID management as well as clinical code index managements.   
  

The PharmaCM solution is a platform to cover the entire content supply chain from pre-clinical through phase IV, supporting a variety of document types as well as content integration points.  

Structured Authoring with Microsoft Office Technologies
As Microsoft has adopted the OpenXML standard, the ability to create efficient structured content authoring and management solutions has vastly improved.  Specifically, OpenXML enables separation of content from the format and authoring platform.  For example, comments embedded into a document from a variety of reviewers can now be extracted from an OpenXML document and displayed inside a MOSS-based view giving a complete report of document discussions.  Additionally, OpenXML allows for content updates to happen in both Word and Web-based environments providing a wide variety of document creation, review and approval processes to be enabled.

Organizations which treat each new regulation as an independent project will end up with a hodge-podge of disparate solutions, which hinders process improvement and efficiency gains.  Intrasphere’s approach is for organizations to adopt a common Structured Content Framework and to plug-in capabilities across different processes over time.  In addition to meeting evolving regulatory requirements, this approach will improve the long-term knowledge capital management by enabling the organization to locate and re-use content across process boundaries.

Intrasphere’s PharmaCM provides the following benefits:

• Improved user effectiveness using the latest Microsoft technologies.  The adoption of the OpenXML standard by Microsoft allows end users to author in the familiar Word environment, without needing to learn the intricacies of XML authoring.
  
• Significantly lower change management effort by allowing users to author and manage their documents in Microsoft Word and SharePoint.  The training effort is minimized, while ensuring the document layout and formatting is easily set and constant across all renditions.
  
• Increased efficiency throughout the processes by finding, authoring, reviewing and approving content in the familiar Microsoft platform.  Intrasphere provides tools to transform content from the OpenXML standard into appropriate agency and industry standards.
  
• Reduced total cost of content ownership by leveraging investment already made by most organizations in the Microsoft platform.  Companies can establish a single platform and eliminate the redundant content management solutions that are embedded throughout the organization. 
  
• Power of publishing the right content to the right resources across the organization in a seamless, easy to use environment.
  

Intrasphere’s structured authoring framework based on Microsoft technologies enables companies to harness the value of their previously unstructured documents.  PharmaCM enables organizations to easily find the right content, re-use content, transform content, and improve knowledge management with out-of-the-box Microsoft technologies.  We work with organizations to ensure that required, valuable information is available and reliable so that new opportunities can be seized and business can be better managed.  Our cost-effective and scalable solutions are built on flexible technical and functional architectures that support re-usable content and executed through proven service delivery models.