NNIT Lifesciences14
Regulatory Affairs

Structured Content Authoring

The Value of Structured Content Authoring for R&D Teams

Structured content authoring is the practice of organizing and creating content in a structured way using a predefined set of rules, templates, and guidelines, along with controlled ways to reuse prior or pre-existing content and to pre-populate key elements. This approach enables R&D teams to improve the accuracy and consistency of content, increase efficiency, and reuse and repurpose content within different contexts, in different formats, and across multiple channels. This is particularly important in the life sciences industry, where accurate and consistent content is critical to support the compliance, safety, and effectiveness of products and can help to improve the speed with which submissions can be reviewed by agencies.

The Evolution of Structured Content Authoring

Structured Content Authoring (SCA) has been around for decades, but early technologies and tools were difficult to use, and required an understanding of markup languages such as HTML and XML. In recent years, tools in the marketplace have matured significantly, and have become more sophisticated and user-friendly. Today, many structured content authoring tools are designed for non-technical users and offer a range of features and functionality to make it easier to create and manage content. 

Simultaneously, tools such as document templates, and document management systems (DMS) have also evolved. Authors and reviewers are now familiar with structured documents and the value of structure in navigating large, complex reports.  This evolution is now enabling R&D teams to consider how SCA solutions fit into their business processes and how they may help them meet their business objectives more efficiently.

Structured Content Authoring Today

There is a current shift in perspective occurring across the industry where organizations are looking to gain more benefits from their regulatory data. Widespread interest in data-centric submissions and collaboration through data exchange are examples of evolving use cases. As a company’s understanding of SCA matures, its expectations and requirements evolve too. A team may start their project by targeting simple automation. However, important capabilities like content reuse, intelligent automation, and automatic data population will bring far greater value to the broader organization.

SCA technologies are also continuing to evolve. Current offerings in the marketplace and their capabilities are changing rapidly. Some SCA tools allow users to create and edit content using a visual interface that closely resembles the final output. Some rely on templates and style guides to provide a set of predefined rules and guidelines for creating content, ensuring that it is accurate, consistent, and compliant with required standards. More advanced tools allow multiple authors to work on the same content at the same time and help track and manage the review and approval processes.

SCA Use Cases

There are numerous use cases for SCA that span regulatory, clinical, and safety functions. The advent of data standards initiatives and requirements, such as IDMP and PQ-CMC, have motivated companies to take a more data-centric approach to document authoring. It is one of the most powerful use cases for SCA since almost 65% of IDMP data is already available within existing documents. Many life sciences teams are considering new processes and technologies that will help them identify, track and manage this critical data.

Other common, high-value use cases include:

  • CMC Authoring
  • Safety Reports
  • Clinical Protocols
  • Labeling
  • Medical Writing
  • Regulatory Submission Documents
  • Enterprise DMS and authoring templates


It is important to consider early-on how wide to consider an SCA approach, and because the marketplace and available solutions are changing so rapidly, the user community at large may require considerable support to understand the benefits they can attain for themselves and the organization.

Monitoring the Evolving Marketplace

Most life sciences teams not only have to find the right technology vendors (remembering that the software element and content elements may come from different providers), but must also identify the right use cases to ensure a successful SCA project where they recognize the value in terms of cost, resource, and time savings, as well as increased compliance and accuracy. It’s important to monitor the quickly changing marketplace in the context of regulatory, technology, and systems compliance needs. A thoughtful approach demands a thorough and structured vendor evaluation which can be time and resource intensive.

NNIT has a working knowledge of the larger SCA market, the myriad use cases, and the strengths and weaknesses of market-leading solutions. By facilitating vendor evaluation activities, and by supporting the organization’s business community to understand the benefits and approach, we bring focus to vendor interactions and make the most of your SMEs’ time.

Contact NNIT to learn how your organization can benefit from employing structured content authoring within your mission-critical processes.