One of the key decisions that can help smooth your adoption of structured content authoring (SCA) is to select the right use case to start with. This first use case must include enough complexity to prove the value of SCA in your organization. It must also be simple enough for authors to work with as they learn to use their new structured content ecosystem.

Content by the Module

Our pharma customers typically come to us for help structuring content in one of the following areas:

  • Module 1 – Global Labeling
  • Module 3 – Quality (CMC)
  • Module 5 – Clinical Reports

All of these areas are excellent candidates for structured content. Each of these modules offer ample opportunities for content reuse, automated data integration, and single-source publishing to multiple output formats.

However, for the best chance at success, we need to look beyond the content. Here are the five criteria we consider when recommending the type and scope of use case for our customers.

 

Five Tips for Choosing Your First SCA Use Case

Several factors influence the success or failure of the pilot use case. Our use case selection criteria are based on our years of experience helping organizations transition to structured content and our understanding of the unique needs and pressures inherent to pharmaceutical content.

 

  1. Business Objectives

Determine your business objectives before you select the content and scope for your initial SCA use case. You need to consider what is the key driver for your transition to structured content?

For many of our customers, the number one priority is to reduce the amount of time it takes to produce content.

For others customers, the priority is risk reduction.

Other common business objectives include:

  • better traceability and a more detailed audit trail
  • containing costs
  • managing translation into dozens or more languages

 

  1. Frequency of Change

Which use case features the most frequent need for updates and changes? This content benefits greatly from structured content authoring. It is much easier and faster to update content managed in components rather than locked into monolithic documents.

Nobody likes the chore of searching through document after document in hopes of finding the paragraph, sentence, phrase, or single data point that needs to be updated. Not to mention the very real risk of leaving outdated content in one or more documents because authors could not find it to update it.

Even better, a move to standardized structured content helps ensure that authors say the same thing the same way even when content reuse from a single source of truth is not possible. This consistency improves findability.

 

  1. Potential for data integration, reuse, and automation

This criterion is the most obvious one. In fact, many of our customers start their journey into structured content by considering the amount of content reuse they could achieve. They also seek solutions to replace risky tasks such as copying and pasting data, manually formatting documents, and managing versions.

For the content that our customers most frequently consider, we find:

  • Global labeling offers an enormous opportunity for content reuse as well as localization management and single-source publishing to multiple output formats.
  • Quality offers numerous occasions to integrate with LIMS, PRDs, and other external systems to automate the flow of data into the content.
  • Clinical reports offer a range of content reuse and data integration opportunities within and across documents.

 

  1. Global impact

Localization management is another key driver that brings organizations to structured content. Any use case that requires translation is a good candidate for structured content authoring.

It’s difficult and expensive to manage translations for entire documents. While translation itself is not typically within the scope of a pilot project, structuring that content now positions that use case to generate more ROI from the structured content ecosystem sooner rather than later.

 

  1. Enthusiasm for SCA

How willing to embrace change is your team? If global labeling content meets criteria numbers 1 through 4 the best, but that team is not in a position to accept major shifts in their way of working or their way of thinking about content at this time, then a different use case will provide a better pilot experience.

Likewise, if medical writers were the first ones to seek SCA but are now buried under looming deadlines for a submission, the organization is better served by selecting a different use case.

Pharma teams have worked in word processing documents for decades. The demands for content have only grown. It can be overwhelming to be the first team to experience significant changes in processes and tools.

The Right Balance

Finding the right balance between simple and complex can make the difference between the successful adoption of a production system and a disappointing setback.

The first use case helps your team demonstrate how the new content reuse and automation strategy will impact real-world authoring scenarios once your structured content ecosystem is in production. Choosing the right use based on this selection criteria will help set you up for a successful pilot and a smoother rollout to the larger organization.

Regina Lynn Preciado