Every industry faces challenges when it comes to creating, storing, managing, updating, and retiring content.
Most content challenges are ubiquitous, present in every vertical. Processes that don’t scale. Too much content to manage and yet the exact right content never seems to be at hand. Authors must copy and paste and (inevitably) tweak content, wasting time and increasing risk. The challenges of time, cost, and risk exponentiate with every new content product in every language.
If these challenges sound familiar, you’re not alone. We’ve helped solve these challenges at many companies in our long history of delighting our customers. In most cases, the solution is to design and implement a structured content ecosystem. A structured content ecosystem is a combination of strategy, system, and process. (For more detail, see Is Structured Content a Hammer?)
The pharma industry faces these common challenges and then some.
Challenges Unique to Pharma
Pharma companies have not historically joined other industries in moving to a structured content ecosystem. In part, this hesitancy is due to three challenges unique to the pharma industry:
- Paradigm
- Product
- Primacy of Data
Paradigm
The paradigm challenge is one reason why pharma companies could not move into structured content as early as other industries did: the tools weren’t ready for them.
Most industries base their content processes on a book-publishing paradigm. Pharma, on the other hand, embraces an academic research and scientific reporting paradigm.
The first several generations of structured content management (SCM) systems reflected a book-publishing mindset. The vendors did not speak the same language as pharma. The software did not provide all the functionality necessary to support pharma’s unique requirements for content reuse, review cycles, and collaboration with health authorities.
The paradigm challenge is becoming less of a barrier now that the SCM industry has matured and the technologies have stabilized. See Is Structured Content Ready for Pharma?
Product
The product challenge is inherent in the nature of the content. Few other industries must meet the level of regulatory rigor that pharma content must pass. On top of that, there is endless pressure to get faster at providing safe, effective drugs to people.
Every drug dossier must meet different requirements from different regulatory bodies around the world. Every marketing product claim must include its regulatory required data. Every manufacturing batch must include a host of data and analysis.
This content receives review and approval cycles from several organizations both inside and outside the pharma company. Each health authority may require different changes to the content before granting approval. Most pharma companies do not have a simple, repeatable process for bringing those changes back into the source content. Writers may need to search a wide body of content to find other areas to update based on the feedback.
After approval, the approved content is typically stored in a document management system (or a network folder on a shared drive, somewhere). However, the next time the medical writers start on a dossier, the previously approved language might not be available to them due the lack of a single source of truth for the content.
The product challenge can be addressed by a structured content ecosystem based on standards. To learn more about what this solution entails, download our whitepaper, The Pharma Content Evolution: Content Reuse and Automation.
Primacy of Data
The primacy of data challenge is that in pharma, data is content and content is data.
There’s data about the drug molecules, data about study protocols, data about animal trials, data about people who participated in clinical trials, data about the outcomes of those trials, and data about dosage, form factors, and methods of administration. There’s also data about manufacturing processes, product ingredients, and safety and quality analyses. Even in marketing content, pharma companies must support every product claim with relevant data to comply with regulations.
Much of what we at Content Rules consider “content” — the narrative, the interpretations, the meaningful analysis — is provided by humans for humans. The content exists to help us make sense of the data. The data itself doesn’t change (unless a human introduces errors during exports, copy/paste, or formatting, that is).
Data is so essential to pharma content that a whole software industry has emerged to provide databases and data-governance systems just for managing pharmaceutical data. Most pharma companies employ several of these systems.
The primacy of data challenge is such a complex challenge that pharma companies have come together in industry working groups to develop solutions. For more information, we recommend the Digital Data Flow: Modernize Clinical Trials By Enabling a Digital Workflow webinar from TransCelerate, a pharma industry consortium.
The Future of Pharma Content
So, what is the future of pharma content? A structured content ecosystem addresses most of these challenges and more.
We believe that a structured content ecosystem is the only way for pharma to produce content at scale. Structured content also prepares content for future technologies such as artificial intelligence and natural language generation.
Pharma is poised to leapfrog the learning experiences encountered by other industries. If you’re ready to solve your content challenges, please don’t hesitate to reach out and set up a time to talk. We can help.
Val is on the Advisory Board for the Technical Communications Program at the University of North Texas. When not working with customers or students, Val can be found sitting behind her sewing machine working on her latest quilt. She also makes a mean hummus.
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