You might think that personalized content in pharma is for marketing purposes only.
For one thing, we don’t think of submissions, quality, or regulatory content as a “content experience.” For another, we don’t think of health authority reviewers as an “audience” with different personas.
For their part, health authorities have not demanded that sponsors provide a fully omnichannel experience. An omnichannel experience provides highly targeted, personalized content that “remembers” where you are as you interact across web and mobile platforms. We’re unlikely to need to deliver adverse event descriptions as a series of 8-second video reels.
However, we do see health authorities evolving in their expectations for submission content. They don’t call it “personalization.” They may call it digital information exchange, digital data flow, or digital submissions. But the goal is the same: deliver the right information at the right time to the right person in the right format, in the language of their choice.
Even within a single regulatory body, different types of experts must review different types of information. Each health authority has its own set of requirements for submission managers to meet. How much more efficient would it be if we could provide exactly the right information to the right person at the right time on the right device, even within the context of a submission?
Submission Content Is Already More Granular than a Document
As regulators upgrade their technology and attempt to scale their own processes, we are seeing more support for providing submission information in a more modular flow than in the past. Rather than wait until every document is complete and finalized, regulators are able to review aspects of the information quickly, in smaller components.
Today, we see this trend in the submission of a clinical protocol synopsis for health authority review before the full protocol document is written. Tomorrow, we may see the information delivered even more granularly. Perhaps just the study rationale and the eligibility criteria will be provided first.
We also see this trend manifest in the requirements and recommendations for lay summaries. We see the emphasis place on transparency not just in drug information but also in how clinical trials are designed, conducted, and documented.
To meet these expectations, the non-commercial side of the business (including but not limited to regulatory, quality, safety, clinical, non-clinical, medical information) needs to learn from their counterparts in marketing.
READ MORE: When in doubt, componentize your content.
Content Components as the New Building Blocks of Submissions
Instead of thinking in documents and reports, we need to think in components of information. After all, a document is just a collection of information organized into a hierarchy.
If we can identify what types of information we need to provide – if we can think about our content as a set of building blocks, from which we construct documents and other deliverables – then we can meet expectations for providing smaller, more targeted information to whoever needs it.
Of course, we can still assemble the components into documents and reports when all necessary information is ready. We just don’t have to wait for everything to be complete before we share information with other internal teams, external partners, or health authorities.
A transformation from a document paradigm to a component paradigm starts with a mindset shift, but it does not end there. Today’s documents do not become a set of reusable information blocks simply because we call each heading and subheading a new component (although that’s a start).
For information to flow cohesively everywhere it is used, the content must be standardized.
READ MORE: 6 best practices for creating reusable global content
The Personalization Paradox: To Personalize, You Must Standardize
Pharma companies already understand the idea of content standards. Regulators, sponsors, universities, and international standards bodies have collaborated for decades to develop industry-wide standards to promote consistency across a wide range of pharmaceutical content.
Data standards have long been important to pharma for making it possible to manage, communicate, combine, and exchange data.
More recently, pharma content teams have become aware of the need for standards to enable similar types of automation for all information – whether written, illustrated, or tabulated – developed across the enterprise.
Inconsistencies in terminology, organizational structure, or formatting create friction for human reviewers. We don’t want them stopping their review to ask themselves (or worse, query the sponsor) questions such as “does this word mean the same thing as the word you used before?” or “is the tabular information in this document the same information thing as the prose information in the other document?”
Inconsistencies also create impediments for systems. A computer tasked with ingesting and transferring the content needs clear instructions in order to retrieve, assemble, and deliver the correct information to the right destination.
CHECK OUT OUR E-BOOK: The Personalization Paradox
Developing Your Content Standards
Even with the availability of industry standards to help guide your internal standards, it can be difficult to know where to start. Most pharma industry standards have been developed with a data management mindset. The data standards approach aligns with content standardization, but does not address every requirement for content.
We developed the Content Rules Five Dimensions of Content Standardization™ framework to better help our customers know where to start. Or, if you’ve already started, to know how to get unstuck and keep moving forward toward your content reuse and automation goals.
As pharma content becomes more agile, it becomes more valuable. Pharma companies can take full advantage of componentized content and emerging technologies to create, manage, and deliver content to more destinations in more formats on an unprecedented scale.
Pharma content teams can produce more information more quickly once they have content reuse and automation in place. Content improves in quality as data and information are reused from a single source of truth. Regulators have fewer needs to request more information when the content is accurate and consistent.
Everybody wins.
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