In pharmaceutical and biotech regulatory document development, your content strategy – the business plan for how you create, manage, and deliver content – significantly impacts your ability to innovate, comply with regulations, and ultimately, bring new medicines to market.
It’s understandable to think that the pharma industry can take a uniform approach to content strategy. After all, a submission to a particular health authority contains approximately the same types of information in approximately the same order, regardless of sponsor.
I say “approximately” because even with the guidance provided by the common technical document (CTD), there is noticeable variation from submission to submission, even within the same pharma company. There is an even more significant difference in the way that content is developed and managed, both within a company’s internal organizations and from company to company.
In fact, how content is developed can be a competitive differentiator in the race to bring treatments to the market.
READ MORE: Writing for structured content in pharma – what you need to know
Content Strategy Is Not One Size Fits All
Content strategy is not one size fits all. As pharma companies embrace digital transformation and explore the application of AI in content development, the impact your content strategy has on your business objectives has never been greater.
Like any other type of business plan, you must tailor your content strategy to serve the unique needs of your business.
These unique business needs include:
- Company culture and way of working
- Tolerance for rigor vs flexibility
- Ripest opportunity for transformation
Company Culture and Way of Working
Many people think that content strategy mostly revolves around technology. They look at the features of the latest tools and replicate legacy processes in the new tool. Or they design new content processes to match those features, even if the new processes are not necessary for achieving the business objectives.
When I build a content strategy with an organization, I consider the Content Rules pillars of content governance:
- Content
- People
- Technology
Content
Content requirements help you develop rules to eliminate repetitive decision-making. For example, these rules may include including or excluding content, reusing content or writing new content, and automating the flow of data into the content.
These rules also help bring consistency into your content. Consistency is the key to findable, usable content.
People
People requirements help you develop processes for how to create, review, manage, publish, and retire content. The methodological approach of your company—be it waterfall, agile, process-driven, or a more freeform style—will significantly influence how your content strategy is integrated and adopted.
No matter how much content reuse you have or how excited everyone is about a new technology, it’s the people who have to work with it on a daily basis. If you focus only on the content or the technology, you risk leaving people behind.
If you leave people behind, the adoption will not be as successful as it could be, and it may even fail entirely. (Spoiler alert: This is why Val and I are writing a book called Technology Is Easy, People Are Hard. Stay tuned.)
Technology
Technology requirements help you identify what system capabilities you need, what’s nice to have, and what you can skip. Technology is the enabler for your content strategy and content development process. Technology should not drive your content requirements or be implemented in lieu of a content strategy.
READ MORE: 7 ways to write for content reuse
Tolerance for Rigor vs Flexibility
Your content strategy needs to hit the right balance of prescriptive rules and flexible guidelines for your organization. An organization’s level of willingness to comply with rules affects both implementation and adoption rates.
Rigor
A highly standardized, rules-based content strategy helps ensure consistency in content and process. These types of strategies attempt to eliminate as much repetitive decision-making as possible. Rigorous rules enable a higher level of automation. They help organizations use AI most effectively. Rigorous rules help organizations achieve greater efficiency and lower risk.
However, getting too rigorous makes it difficult to handle edge cases. Unusual content may require a higher level of painful workarounds or manual effort to handle the uncommon requirements than in a less rigid strategy.
Flexibility
A more flexible strategy that prioritizes guidelines over rules leaves more decisions in authors’ hands, at the cost of system automation. A more flexible strategy works well in start-ups and in smaller organizations where rapid change is expected.
However, automation depends on standardization. The more leeway authors have in how they develop content, the less the systems are able to step up and perform repetitive tasks. Without automation, the risk of including inaccurate, conflicting, or redundant content in regulatory documents is much higher.
Ripest Opportunity for Transformation
Adopting structured content authoring (SCA) is the most effective way to empower your content development teams to meet ever-changing demands on a global scale.
I understand how the allure of AI can distract an organization from the journey to adopt structured content. I’ve seen some successful proof-of-concept projects produce extremely alluring results, reducing content development time and improving content quality.
However, even with AI helping us extract data or generate content, you still need component-based structured authoring to track, manage, and product all the right outputs. Traditional document-based authoring and document management cannot help you provide the right content to the right person in the right format with any kind of efficiency or accuracy.
READ MORE: 5 tips for selecting your first pharma SCA use case
Accelerate SCA Adoption with Expert Guidance
Adopting structured content authoring is a journey that requires more than just the right tools. It demands a change in mindset and workflow that can be challenging to navigate without expert guidance.
The expertise of professionals who specialize in SCA implementation for the pharmaceutical industry can provide invaluable insights into best practices, common pitfalls, and strategies for successful adoption. This guidance can significantly accelerate the digital transformation process, ensuring that your content strategy aligns with your unique business needs as well as industry standards.
As different groups align their ways of working to a content strategy enabled by technology, the business achieves measurable results. The organization can look ahead to reducing time to market, containing direct and indirect costs throughout the content lifecycle, and eliminating high-risk manual processes.
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