Even as recently as 10 years ago, and definitely 20 years ago, moving from unstructured documents to component structured content appeared to entail too much risk for pharmaceutical companies to throw themselves into it. In what one pharma veteran refers to as “the rich ol’ days,” companies could respond to increasing demands by adding more people to projects.
Those days are over.
Today, the risk profile has reversed. There is more risk in staying with word processing documents than there is in moving to structured content authoring.
To provide the most accurate information in the least amount of time, pharma companies must automate many aspects of content development. These aspects include content creation, review and approval cycles, and assembling and formatting documents.
To automate content development, pharma companies must move to structured content authoring.
Only with structured content authoring can pharma companies continue to meet regulatory requirements and reduce unnecessary delays in drug development.
Let’s look at two areas where risks can be mitigated by structured content authoring:
- Increasing demand for content development
- Evolving expectations for content delivery
READ MORE: Stop wasting time creating redundant content and do this instead
Increasing Demand for Content Development
New regulations often result in demands for new or different types of content. Trends in drug development processes also result in demands for more data and more content about that data. For example, as clinical trials become more diverse in their study populations and more distributed in their geography, the information we provide about the trials likewise becomes more complex.
Writing, reviewing, approving, formatting, and publishing documents full of data is fraught with risk. It’s too easy to introduce errors and perpetuate errors through copy/paste. Then when the error is caught, it is both time-consuming and tedious to find every place the information is provided and correct it. There is risk of not finding all the errors – typically due to redundant content that uses different words – and having the regulator find it and send the document back for updates.
We’ve reached a point where people manually working in word processing documents simply cannot scale any further. Authors are overloaded with rote tasks like copy and paste, formatting and reformatting, and managing multiple review copies of the same document. Never mind trying to find similar information in other documents when a reviewer requests a correction in one document.
Every inaccuracy or simple human copy/paste error increases risk of inaccurate information making it through to the regulatory reviewer. This inaccuracy occurs not only in that one document, but is perpetuated throughout the dossier by copy/paste.
This risk is high even with programming scripts or macros that automate copy/paste across documents. As soon as you have two or more duplicates of the same information, the risk for error perpetuation increases. So does the risk of not being able to find all the instances of the error when the time comes to correct it.
We’ve reached our limit with manual efforts to keep data and narrative aligned throughout a submission or post-marketing reporting.
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Evolving Expectations for Content Delivery
Expectations for how pharma delivers information continue to evolve. Artificial intelligence, natural language generation, intelligent automation, and digital information exchange dominate the conversations and the agendas at cross-pharma conferences, webinars, and consortiums.
Major health authorities have declared their intent to move toward digital submissions and exchanging information outside the boundaries of a document.
Accumulus Synergy, a consortium of household name pharma companies and software developers, is already working on a submission platform to enable data exchange between sponsors and regulators.
For these technologies to be successful, the content must be standardized in all five dimensions: output type, component, paragraph, sentence, and word. The content must be created and managed in components. These components must be tagged with metadata so that machines can find and retrieve the right component at the right time.
Component structured content is a way of creating, managing, and assembling content into documents that meet regulatory requirements
READ MORE: Writing for structured content in pharma – what you need to know
How Structured Content Authoring Lowers Risk
Developing content in documents requires a lot of manual effort from humans. Manual effort that is no longer necessary.
Structured content authoring reduces risk in a number of ways, including:
- Replace copy/paste with content reuse
- Automate document assembly and formatting
- Retrieve data from source systems
- Provide full traceability and change history at more granular level than document
- Automate metadata tagging and validation
Until recent years, the barrier to replacing word processors with structured content authoring was high enough that pharma companies chose not to make the switch. Today, the technology is mature and the user experience is much closer to a document-based authoring environment.
With structured content authoring, content development takes less time and results in more accurate, higher quality content. The content is assembled, formatted, and published to documents. Those documents are then sent to the RIM system for inclusion in submissions and for archival and document management purposes.
Structured content authoring eliminates the need to re-create the same content over and over again, format and re-format it, and manually find every instance of similar content to correct or update it.
The risk of perpetuating errors across the dossier is eliminated. If an error is made in the source of truth, you make the correction in that one place. All documents that reference the information automatically receive the correction. No more days wasted combing through thousands of pages with manual Find/Replace operations.
Documents can reference the single source of truth by automatically including the information or by automatically linking to it, depending on the need. Years from now, you may not need to reuse the information across documents at all. The information will be sent directly to each health authority that needs it.
With structured content authoring, the changes in the way of working and the technology that supports it are most often transparent to the health authorities. For now, regulatory reviewers still review the documents as documents. They won’t know that the documents are assembled from components based on standards. They may notice that the content is accurate, consistent, and high quality. They’ll find it easier to review, with less back-and-forth with the submitter.
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