​Why Regulatory Writers Need to Prototype Smarter

Drug development regulatory submission documents are among the most structured documents in
existence—and yet they are often developed in the most chaotic way. As I mentioned in my previous
article, teams wait too long to think, treating Draft 1 as the beginning rather than the outcome of
deliberate information design planning.

Instead of aligning early on logic, purpose, and reader needs, teams begin reacting to prose—often in
the form of a partial draft or outline labeled as a “prototype.”. The result? Wasted cycles, misaligned
arguments, poor document flow, and late-stage rework that drains time and undermines
confidence—especially in mission-critical documents like Clinical Study Reports and the eCTD Module
2.5 Clinical Overview.

I suggested in my previous article that development teams need to reconsider what they are generating
as document prototypes. Most teams mistake an outline for a prototype. But there’s a key difference:

• An outline shows you what sections and details to fill in.
• A prototype shows you how the thinking should unfold.

Outlines help establish the physical architecture of a document. However, I suggest what really counts is
the establishment of the intellectual architecture of the document. The “So what?” and the “Why?” that
are at the core of evaluating, justifying, and arguing.

This is the foundation of regulatory writing. After all, the purpose of a submission is not to describe—it is
to evaluate, justify, and argue. Those three writing actions sit at the heart of how health authorities
assess benefit–risk.

From “Primitive Forms” to Design Thinking
The word prototype comes from the Greek prototypon—meaning “primitive form” or “original model.”
Historically, the concept of building rough models or mock-ups has existed for centuries. However, it
was not until the late 1960s that prototyping emerged as a recognized approach in document
information design.

In software, prototyping gained traction in the early 1970s as an explicit strategy to manage evolving
requirements. Winston Royce—often miscredited with creating the Waterfall model—emphasized the
importance of incorporating prototyping within code writing to reduce risk. By the 1990s, “document
prototyping” became mainstream in many industries that demanded logic and tracebility.

Prototyping is not about language and shell tables. It is about early validation of logic, flow, and
alignment. A concept that is either poorly understood or undervalued in many Pharma houses.

Prototyping as Structured Thinking
A real prototype is not a template filled in with placeholder XX, Y% and p-value of 00.0X. A prototype is
the framework for judgment. A prototype helps teams clarify what each section must do—not just what
it must include.

​One powerful tool to use is a prototype planning matrix, which breaks down each section into five core
elements:

This is the logic scaffold that the decision-making regulatory readers are looking for.

​Let's walk through an example:

Keep in mind the “So what?”
The message is not a study endpoint. The message is a decision in sentence form. The data supports that decision, but the message must guide how the data is presented and evaluated.

Teams tell me all the time, “it is all about the data.” I get it. It is indeed about the data. So, during
prototyping is the time to make the data needs visible. Where do you need a table, figure, or reference?
Too many teams wait until late in the document lifecycle to consider what tables or figures will help
carry their argument in a Clinical Overview.

Writing Actions and Functional Thinking
In my approach, each part of the prototype needs an associated thinking task. What does this section
“do” for the reader. It is not about the reporting, it is about the doing:

• Analyzing variability, relationships, trends
  
• Evaluating strength of evidence
  
• Justifying choices and interpretations
  
• Synthesizing findings across studies
  
• Arguing a benefit–risk conclusion

A prototype needs to be centered on function— is not about what the team wants to say. It’s about what the document must accomplish. That means designing—yes, designing—documents that are fit for function.

A strong prototype exposes reasoning, not just structure. It shows how the argument flows, where the
evidence lands, and whether the logic holds—before prose locks your thinking into place.

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
New Article: Why Regulatory Writers Need to Prototype Smarter
In drug development, we create some of the most structured documents in the world—yet they’re often
developed in the most chaotic ways.

Too many teams treat Draft 1 as the start of thinking, rather than the outcome of it.
In my latest article, I explore why regulatory submission documents—especially eCTD Module
2.5—require prototypes that reveal logic, not just structure. I walk through the difference between
outlines and prototypes, introduce a five-part heuristic planning tool, and share examples of how to
build prototypes that support decision-making for regulatory readers.

It’s not about formatting—it’s about function.
It’s not about writing early—it’s about thinking early.

Read the full article here: https://www.linkedin.com/pulse/why-regulatory-writers-need-prototype-smarter-gregory-cuppan-solmc

Let me know how your team approaches document prototyping—and what gets in the way of doing it
well.