Writing for Structured Content in Pharma: What You Need to Know | People sitting on a laptop, animated | Content Rules

What is the Definition of Structured Content?

Structured content is content that is modular, consistent, and reusable.

The foundation of structured content is the idea of the “component.” A component is a unit of information that can stand alone or be combined with other components to create a document or other output. A component can include any type of content, such as prose, tables, or figures.

Structured content is designed to be machine-readable so that we can automate tasks such as:

  • Create working documents from templates in bulk
  • Assemble content into the correct order and hierarchy
  • Reuse content within and across documents
  • Apply formatting, layout, and pagination
  • Retrieve data from another source
  • Track every change throughout the content lifecycle

Structured content systems enable us to pre-populate documents with reused content, templated text, pre-formatted tables, metadata, and data retrieved from other sources.

With structured content, components can be automatically or manually assembled into the required order and hierarchy to produce documents and other outputs. Authors can use their time to create valuable content rather than copying and pasting, formatting a Word document, or manually moving components into place.

Structured content can mean different things to different organizations. Some organizations define structured content in terms of the underlying technology. Other organizations define structured content in terms of the business objectives enabled by structured content management.

READ MORE: How to create an effective structured content ecosystem 

What Types of Content are the Best for Structure?

Pharma content abounds with opportunities to benefit from structured content. If you were to ask us what the best content for structured content authoring in pharma is, we’d probably have to answer “all of it.”

One of the activities we perform early in a content architecture engagement is to help determine which use case will go first. A number of factors inform that decision. What works for one company may not be the best choice for another.

Many types of content benefit from structured content authoring. A structured content ecosystem is ideal for creating, managing, and delivering content that meets one or more of the following criteria:

  • Regulatory guidelines define what content to include and in what order, such as for clinical reports and labeling
  • More than 5 to 10 percent of the information could be reused, such as across clinical reports or labels
  • Different authors or SMEs work on different parts of the same document, such as in clinical, labeling, and CMC
  • Every instance of the same document type must be formatted with the same layout, font styles, headers/footers, and other design elements, such as any document included in a submission
  • Content is localized or translated, such as labels and packaging
  • Content requirements vary by country, such as Quality/Module 3 reports
  • Content contains standardized (or standardizable) text that could be reused, such as eligibility criteria descriptions or therapeutic area definitions
  • Content contains information that can be structured to align with industry standards such as CDISC Unified Study Data Model and HL7 FHIR
  • Content contains master data or transactional data from other sources, such as Quality/Module 3 reports
  • Need to produce different variants from the same set of information, such as in labeling and medical information
  • Need to deliver a focused or personalized experience, such as in medical information, education, or commercial

Today, a typical dossier for a single drug product contains a large amount of redundant content, created by many authors across many documents produced over many years. It’s not humanly possible to ensure consistency or reduce redundancy across so many teams, so many documents, and so much time.

A submission includes several summary documents in an attempt to present the most relevant information to different audiences.

A structured content ecosystem enables pharma organizations to implement automation to ensure consistency and accuracy of information throughout the dossier. Content reuse eliminates the need to create, review, reformat, or republish redundant information. Automated formatting eliminates the need to correct heading styles, list indents, table borders, and other repetitive issues common to authoring in Microsoft Word.

When we think about structured content in pharma, we must think beyond the operational efficiencies. We also consider the reduction in risk that comes with improving content quality and consistency through structure and automation.

Structured content is the most effective way to train Generative AI (GenAI) systems to produce accurate content and provide it in the right place.

READ MORE: Your current pharma content ecosystem might be slowing you down. Try this.

Which is the Recommended Method of Implementing Structured Content Authoring?

Content Rules designed our proprietary Structured Content Authoring for Pharma(tm) methodology to provide a flexible framework to help implement structured content authoring for any pharma organization. We believe it is the best method for implementing structured content in an iterative and effective process.

The keys to success are:

  • Strategy before systems. A structured content strategy is a business plan for your content. It defines the information architecture to structure of the content, the taxonomy and metadata to organize the content, and the workflow and governance plan to manage the content. The technology should support the content requirements, not drive them.
  • Iterative roadmap. The organization needs clearly defined milestones and “quick wins” throughout the transition to ensure the project continues to move forward successfully.
  • Change management. Implementing structured content authoring for pharma is a full digital transformation within teams that have spent 40 years in a digital version of the print-publishing paradigm. People need support to ensure they feel confident in their new skills, new tools, and new way of working.
  • Write for reuse. Authors need to write with content reuse in mind. This shift takes some training and practice before it becomes “just how we write.”
  • Expert guidance. Pharma companies typically do not have a wealth of experience with structured content in-house. An expert guide helps organizations avoid pitfalls and roll out structured content authoring effectively. The Content Rules methodology helps pharma teams build these skills and provides a foundation to build on as needs evolve.

Content Rules knows how to help pharma organizations implement structured content authoring. We do it every day. Our experts were instrumental in developing structured content best practices adopted by all industries worldwide. We have influenced the technologies on their maturation journey over the past 15+ years.

We are unique in the industry in that we only provide content services. Our expertise is in content. We are the go-to partner for leading pharma consulting agencies and structured content management vendors.

We are not a software vendor. Rather, we work with all leading software platforms to help ensure the best fit for our customers.

READ MORE: What’s the difference between content reuse and content repurpose? 

Creating a Structured Content Strategy

One crucial step in adopting structured content authoring is to create a structured content strategy. The main parts of a structured content strategy are:

  • Content models, which define the structures for each type of element, component, and output
  • Reuse strategy, which defines what content to reuse, where to reuse it, and how to reuse it
  • Content standards, which include structured authoring guidance along with terminology, grammar, and style requirements
  • Taxonomy, which defines the classification and organization of your content repositories
  • Metadata, which defines the “tags” that identify each piece of content
  • Workflow, which defines the content status and flow through the entire content lifecycle management process
  • Governance, which defines the plan for managing change as needs evolve

The structured content strategy informs decisions about systems, processes, and integrations. However, the structured content strategy is independent of systems. The strategy should be driven by the requirements of the content and the business. The systems then support the business in meeting those requirements.

There are different schools of thought for how to create a structured content strategy. Content Rules has developed a methodology for helping pharmaceutical organizations develop a structured content strategy that works for them. This methodology incorporates the factors that make pharma content unique when compared to other industries.

Writing for Structured Content

Writing reusable content is one of the keys to successful structured content authoring (SCA). If content is not written according to your defined structures or content standards, that content cannot be reused seamlessly.

Medical and scientific writers need to build new habits about how they organize and write information. It takes some training and some practice to solidify these new habits.

Structured content writing is based on the principles of consistency and clarity. Structured content provides ample opportunities to use templates, content reuse, and other content automation to help large teams of authors produce consistent, clear content over the full lifespan of a drug product.

Structured content requires authors to think about content as a set of building blocks of information rather than as full documents or other deliverables. One of the important features of structured content writing is that authors can write as if they are working in a structured content system even before the organization adopts structured content management.

Content Rules offers training courses and ongoing mentoring to help medical writers, technical communicators, and other scientific communicators develop their SCA skillsets. We also offer content writing and content editing services to help pharma teams through the transition period of adopting structured content authoring.

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Regina Lynn Preciado