In the Biopharma industry, speed, accuracy, and efficiency in starting clinical trials, reporting their results, and preparing marketing application submissions are critical to getting new treatments to patients in need. The ability to create, share, navigate & find, reuse, track, and protect essential content is critical to efficiently developing these new treatments and getting them launched.

Much of the information created, shared, and reviewed/approved is captured in unstructured documents developed throughout the product development lifecycle. Many of these documents comprise reusable components, which are derived from content generated by clinicians, clinical pharmacologists, statisticians, toxicologists, and other subject matter experts, increasing both the complexity and volume of information about the product. In the pharmaceutical industry, for example, development of a new drug from target identification to approval typically takes 10+ years or longer. During this period, thousands of documents are created to describe the drug’s safety, efficacy, and manufacturing characteristics. The ease of sharing information across documents and the quality and consistency of this information throughout the product development period is critical to supporting efficient development and a successful marketing application.

At InteliNotion, we introduce the concept of Intelligent Content Networks. These Networks are analogous to neural networks where content components can have linkages to many documents and can be traced. Structured Content Management (SCM) is the basis of an Intelligent Content Network. With SCM, content is authored, reviewed, and approved at a component level first (i.e., more granular than a document). These components can then be assembled into collections such as documents or dossiers. Structuring the information within documents into self-contained reusable components and reusing/repurposing information within and across documents with full traceability is essential for improved efficiencies, quality, and consistency during the authoring, review, and approval processes. This approach promotes easier methods for downstream uses of the information currently embedded in documents by allowing the appropriate components of content to be published/transformed into required formats for downstream documents, systems, or applications. Maintaining the traceability of reused components as Intelligent Content Networks is mission critical to ensure consistent content quality and the ability to track and assess impacts of change.

InteliNotion is a revolutionary, Cloud native, highly secure and scalable platform built using the most advanced Web technologies. Our approach introduces a new generation of groundbreaking solutions for Intelligent Content Management and Information Governance for the Biopharma industry. The InteliNotion platform, together with the industry-specific pre-configured models, templates, and rules, provides a rapid configure/deployment approach to support key business documentation needs.

The InteliNotion platform offers the following:

  • Tools for the Information Architect to configure and classify the structure of components and documents, and define reuse rules, governance processes, and lifecycle policies for the components.
  • The ability to create and manage Libraries for Standard Text and Instructional Text.
  • An authoring platform native to Microsoft Word.
  • Industry-specific templates for components, documents, rules, and governance that can be quickly tailored for client-specific needs (e.g., clinical document compendium, labeling, manufacturing).
  • Review and approval workflows for components and documents.
  • Conditional Publishing features to tag content for output transformation/redaction, as well as publishing to PDF, Word, XML, and other formats.
  • Full traceability of components, within and across documents.

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