We talk a lot about the goal of enterprise content strategy for pharma: to help speed up the process of making safe, effective medicines.

One part of achieving that goal is to get content through regulatory approval faster. To speed up review and approval, pharma content must be:

  • Easy to find, access, and understand
  • Accurate
  • Consistent
  • Complete
  • Compliant

This is why health authorities and pharma companies are working to define a new paradigm for content. The new paradigm is based on digital capabilities for information exchange rather than on traditional, paper-based publishing.

One of the digital capabilities being adopted is support for greater granularity in the content.

Granularity Is a Go for Submissions

The eCTD v4.0 standard – due to be released officially in the coming year – includes support for greater granularity in the dossier. Granularity means the smallest unit of content that can stand alone or be combined with other units of content to create a deliverable such as a Protocol or Clinical Study Report.

Greater granularity in the dossier means that instead of submitting a large PDF that locks data and content into a single document such as a Clinical Study Report, sponsors can submit a number of smaller PDFs that each focus on a particular subject area. Together, those PDFs contain all the information required for the CSR. They just group the information together in smaller “chunks.”

For example, the CSR section of the dossier can include a PDF that provides required information about adverse events. The adverse events PDF is a subset of the full clinical study report. If the health authority requires a change to the adverse event information, the sponsor only has to update and resubmit that one file for review. The change does not require the entire CSR to be resubmitted, nor does it trigger a new review of the entire CSR.

The benefits of greater granularity in submission include:

  • Sponsors can update and resubmit just the file that needs it, without triggering a new review of an entire report
  • Regulators can easily match individual files to the appropriate reviewers, rather than routing an entire report to everyone, even if only specific sections need to be reviewed.

Content Reference Replaces Redundant Content

With greater granularity throughout the dossier, cross-references and links to other content become much more precise. This precision enables reviewers to find the information they need more quickly. It also reduces the time spent producing documents.

For example, the Protocol includes information about the study population. Traditionally, authors copy this information into a CSR and then edit the text. For every CSR, the study population information changes to some degree, as authors copy from the original Protocol or from other CSRs, and then edit the text again.

Authors and publishers must then determine how to cross-reference that information from other areas of the dossier. Which document contains the source of truth that should be referenced? How will one document provide a “deep link” to a level 5 section of the source document?

These challenges are eliminated by a defined source of truth and a granular unit of content to point to.

With a more granular eCTD, the study population information can be included in its own file that is a subset of the full Protocol. The CSR section of the eCTD can then refer to that file. If the study population information requires updates, the one file can be updated separately from the rest of the Protocol and CSRs. Every CSR can refer to the source of truth rather than contain its own version that has been copied, pasted, and tweaked manually by authors.

Component-Based Authoring Enables Granular Submissions

The smallest level of granularity in use in the eCTD is not quite as small as we normally recommend for authoring. The good news is that you can develop content in smaller components and then combine them to make the larger components for the eCTD or any other output type that needs that information.

While there is no “one size fits all” for pharma content granularity, there are several areas of content that benefit from the smallest of reusable components (one paragraph, which may be a single sentence). Other areas of content require larger reusable components that may include several paragraphs, figures, and tables. Still other areas are entirely unique, never reused, and may only need a high-level structure to keep them consistent with the rest of the content.

Your content reuse and automation strategy determines how granular your content should be and defines the standards your content should follow.

A Major Step Forward

The level of granularity supported by eCTD v4.0 is a step forward in the digital transformation of the pharma content lifecycle. It is a major step in the transition from a paper-based publishing paradigm to machine-readable, human-friendly ecosystem for information exchange.

A component-based, structured content strategy helps get content through regulatory approval faster. It’s a win-win. Pharma organizations can assemble submissions faster, while reducing risk of errors and inaccuracies. Health authorities can review the submission faster and encounter fewer questions in the integrity of the data.

There will likely come a day when the dossier is no longer a set of PDFs organized by an XML tree. We’ll exchange information in XML-based structured content components that machines organize so that humans can find, access, and comprehend content quickly and easily.

This goal is a key driver of the paradigm shift happening in major health authorities all around the world.

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