The pharma industry has come together to develop technical solutions that speed time-consuming processes and reduce errors that can cause risk to the business and ultimately to patients.

 The goals of these technical solutions include:

  • Facilitate digital information exchange between CROs, sites, sponsors, regulators, and EHR systems
  • Guide decisions at the point of care
  • Automate repetitive, risk-inducing tasks such as copy/paste 
  • Eliminate the creation and maintenance of multiple copies of the same information with no definitive source of truth or source of record
  • Increase quality of submissions while making it easier and faster for regulatory reviewers to find the data and content they need

To enable these goals, the technology providers have leveraged XML. XML, or eXtensible Markup Language, is a text-based format for representing structured information. XML was derived from an older standard called SGML (ISO 8879). XML has become the standard for component-based, structured content management and information exchange across all industries, including the life sciences. 

Several XML standards have been proposed to help identify, organize, and automate pharma content. 

A Standard has a Schema, a Schema Sets the Standard

Each XML standard includes an XML schema. An XML schema defines the rules for the standard. The schema defines criteria such as:

  • Metadata used for machine processing that describes your content, such as whether a paragraph that describes a study population is called “paragraph” or “study population description”
  • Relationships between one piece of content and another, such as requiring that a product claim must always include its supporting regulatory information
  • Conditions for when to include or exclude content, such as to enable automated redaction of sensitive data

Here are some examples of XML schemas that are in use today:

  • HL7 FHIR (Fast Healthcare Interoperability Resources) that defines information exchange between different systems
  • CDISC XML schemas to support data exchange for clinical trial summaries, study datasets, and case report form content
  • eCTD, which is built on an XML schema that provides a tree structure to organize the entire dossier
  • SPL format that relies on an XML schema to organize labeling documents

What happens when you have dozens of XML standards, each one with its own XML schema to define and enforce the rules? With so many schemas, which one is, well, standard?

XML Plays Well with Others

One of the tremendous advantages of XML is that content that adheres to one XML schema can be mapped to systems built on another XML schema. The technical mechanism of mapping might be an XML transform, an API, or some other method of translating one set of XML to another. 

As long as the content and data conform to the rules of a particular XML schema, the information can be mapped to another XML schema. (There are some caveats to this statement. Both schemas need to have enough equivalent content types to accommodate the mapping. You’ll probably be relieved to know that the technical details are out of scope for this article.)

Flexibility is one of the reasons that XML has become the standard for component-based, structured authoring in just about every industry, including pharma and medical devices. It’s why XML is used for every type of content, from scientific authoring through experienced-based digital marketing. 

A Standard of Standards

Because XML enables you to define your content semantically by what it is (a description of a study population) rather than what it looks like (a paragraph in 11-point Times New Roman), you can do almost anything with the content. For example, you can:

  • Automate content assembly based on defined structures and planned content reuse
  • Automate content formatting and publishing using stylesheets and transforms, which transfer the unformatted XML content into any design and file type (PDF, MS Word document, web page, presentation, mobile app, etc.)
  • Integrate data into the content based on variables, identifiers, and attributes

The ultimate goal everyone wants to achieve is to provide faster delivery of safe, effective treatments to people who need them.

We all know that standards make things work together. Plumbing standards allow us to purchase just about any faucet and know that it will connect to our pipes. Electrical standards allow us to replace old dumb light bulbs with new smart light bulbs, and know that they will not only screw into the socket just fine, they won’t shock us, explode in our hands, or set the house on fire.

For pharma, adopting XML standards and developing technology to connect the content and data according to those standards is a huge leap forward. Adoption of XML standards reduces risk, time, and cost compared with traditional ways of developing and delivering content. With XML standards in place, the industry can also prepare data and content for intelligent automation, machine learning, and artificial intelligence.

Content Rules is the only end-to-end service provider with experience in pharmaceutical content.  We have helped numerous companies transform from document-based publishing to component-based, structured content management. We developed our Five Dimensions of Content Standardization Framework to help companies standardize content in all five dimensions to ensure that content is FAIR: findable, accessible, interoperable, and reusable. We can help you solve your complex content challenges. Contact us to see how we can help you!

Regina Lynn Preciado