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also published to LinkedIn March 29, 2025
Regulatory documents are not just technical records—they are tools for decision-making. But too often, these documents are burdened with unnecessary details, redundant explanations, and background that buries the point. Lean writing clears that clutter. In regulatory writing, every word should do work. Lean writing prioritizes clarity, brevity, and logic. This approach to writing strips away “filler,” flattens convoluted phrasing, and sharpens the path from “So what?” to the answer and then to the supporting details. Lean writing improves comprehension, speeds review, and supports more confident decisions across protocols, study reports, briefing books, and submission summaries. Where Does Noise Come From? Noise creeps in through:
The result? A longer document that unfortunately communicates less. Why Noise Hurts: Cognitive Load in Regulatory Review Noise increases cognitive load, the mental effort required to process information. Regulatory readers often need to make high-stakes decisions within very short time periods. When documents are packed with extraneous detail, the regulatory reader is routinely forced to:
These obstacles drain attention and slow review. In contrast, lean writing is intended to reduce cognitive friction. The lean writing style respects the reader’s mental bandwidth with the goal to accelerate reader insight. The ability to get to the "So what?" How Lean Writing Helps Lean writing addresses cognitive load by making the structure of meaning visible. Regulatory readers need to quickly see what matters: design rationale, data integrity, safety profile, benefit-risk conclusions. When writing gets in the way of that mission, efficiency—and sometimes trust—suffers. Examples of lean writing strategies:
Before and After—A Lean Writing Example from My Book: Writing for the Biopharmaceutical Regulatory Reader Before: “It should be noted that the trial, which was conducted at 20 sites across multiple regions, was designed in a manner that would enable the evaluation of both the safety and the efficacy of the investigational product in a population that was considered to be representative of the target treatment group.” After: “The trial was designed to evaluate safety and efficacy in a representative population across 20 sites.” Lean writing makes the message clear and reading fast and actionable. Writing Is a Regulatory Efficiency Tool Streamlining your writing improves not only readability, but also document quality. Lean writing sharpens the argument, exposes gaps earlier to the authoring team, and helps regulatory readers stay focused on what matters most. In short: lean writing supports regulatory success. Here, I define success as a marked reduction in RFIs and protracted effort to give the regulatory reader the “So what?” Want to go deeper? My book, Writing for the Biopharmaceutical Regulatory Reader, shares practical strategies to improve clarity, logic, and usability in regulatory documents. Get the book here https://www.mcculleycuppan.com/books.html Want to improve your team’s writing? I help biopharma teams improve the communication quality of their protocols, briefing books, clinical summaries, and study reports to improve clarity and enhance the regulatory review process. Message me if you’d like to talk about training or document development support.
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originally posted to LinkedIn July 2023Been a bit since I’ve posted an article here on LinkedIn. My wheels are still turning on thoughts about writing in the biopharmaceutical space. Perhaps the wheels are turning just a little slower. But, at least the wheels still turn!!
Purpose of this article is to share some thoughts on writing actions that should happen within biopharmaceutical research reports and keystone regulatory submission documents. These are the actions that enable a document to be considered a high-quality communication platform. For each action, I present the associated parameter that describes the action. Please take 5 minutes to read through this list and if you have further time, please share your comments on the merits of what I have compiled as descriptors of writing actions. Analyze
The Optimizing Medical Writing for the Regulatory Reader Workshop will now be held 29-31 October in Copenhagen. More information on this three-day workshop can be found at the Atrium website: https://www.atriumcph.com/course/Optimizing-Medical-Writing-for-the-Regulatory-Reader/56871 Watch for the full program announcement from Atrium. In interim, here’s the “thumbnail” overview of our course:
Day 1
I will be co-facilitating Optimizing Medical Writing for the Regulatory Reader in Copenhagen in August. This will be a three-day public workshop that will allow attendees time to dive deep into the topic with expanded discussions and group exercises using case study documents. More details can be found on my LinkedIn page or on Atrium's registration page.
Document review in pharma and medical device enterprises is a system of diverse and complex functions that requires proficiency in technology, process discipline, and most importantly intellectual capital.
In terms of technology, there is the management and optimization of the review platform capabilities, the appropriate use of technology assisted review, and effective data security controls throughout the documentation life cycle. As we think of process discipline, there is the need for various robust policies and procedures and a commitment at a senior level to execute those policies and procedures consistently and effectively. Additionally, there is the need to carefully consider the right time/correct role deployment of people during the various reviews. As for intellectual capital, I mean there is effective knowledge transfer; knowledge retention; learning, training, technological, statistical, and linguistic acumen applied to every round of review. In essence, the careful curation of document review expertise. Taking a hard look at review, there are a lot of moving parts and as time lines are reduced and the scale and complexity of document platforms rise, the need for a well-functioning environment rises exponentially and perhaps even geometrically. From my perspective, this means, the value of organizational competence in document review as denoted by process maturity far exceeds the value of the component parts (people, process, technology). In short, the best technology (if one exists) and the “best” people may be utilized, but if the organizational vision within which they operate is deficient, the result will most likely be sub-optimal. It is process maturity that provides the framework in which the contribution of people and technology can excel or be inhibited. When it comes to document review in pharma and medical device, I keep thinking about Peter Senge's comment: “Organizations break down, despite individual brilliance and innovative products, because they are unable to pull their diverse functions and talents into a productive whole.” It has been some time since I last posted here on the McCulley/Cuppan blog. Just like some other things in my life, I simply got out of the habit. So, like my physical workouts, I am looking to make blog posts a more regular part of my life.
With that said, onto the question I want to consider in this post--why are most research documents that cross my computer screen written in the passive voice? Literally, many, if not all of the clinical research reports, much of the regulatory documentation, and painfully all of the clinical research protocols are written in the passive voice. Why do I even bring this topic up? Well, some researchers in the academic community feel that the use of the passive voice (verbs that do not indicate who or what is doing the action) can lead to writing where the sources or agents of action are not clear. This is my big criticism of protocols, a class of documents centered on characterizing events and agents. These writing researchers also comment that repeated use of the passive voice results in texts, which are “flat and tedious” to read. From my very subjective perspective, I have to agree with that last comment as I have certainly seen my share of documents that fit this description. It is worth noting here too that reading research shows most readers prefer active voice, especially readers for whom English is not their mother tongue. The point of this blog is not a grammar lesson (trust me I’d never do that as I almost fall asleep from boredom when someone mentions the word grammar.) But just to be sure we are all on the same page by what I mean with ‘passive voice’ versus ‘active voice’; here is my explanation in a nutshell:
Passive sentences that I read by the truck load contain phrases such as these:
The worst abuse of passive voice is the heavy use of state-of-being verbs combined with past tense: (is, was, be) + (past tense) like the following examples:
So back to the point of this discussion. I ask this question about the habitual use of the passive voice because many science journals, like Nature, and most of the leading style guides recommend the active voice over the passive voice. So if the top-flight journals like Nature and the leading style guides like the Chicago Manual of Style recommend writing in the active voice, then why do people working in pharmaceutical and medical device companies still demand passive voice as the default style pathway? When I ask people in the workshops I teach at various pharmaceutical and medical device companies why they slavishly write in passive voice, the answers range from: “I did not know that is the style I was using.” to “This is the way science must be written.” Ignorance is never an acceptable excuse, but to invoke the need to meet some mythical style-standard is absurd. The slavish use of the passive voice in science writing is a self-maintained and mutually-committed act drawn from a fairy tale. I use the term fairy tale here with careful consideration. Fairy tales are about imaginary worlds. Hereto we have a situation where people imagine what readers want and prefer and routinely invoke the imaginary in defense of their personal or organizational belief system about high quality scientific writing. From my perspective, the two leading reasons that the passive writing style is so broadly applied are:
I am working my way through some papers addressing the psychological mechanisms that form and maintain habits in work groups and organizations. Now I am looking for references related to the meaningful steps necessary to mitigate or eliminate these habits. When and if I find an effective elixir for this bad writing habit, I will let you know. |
AuthorGregory Cuppan is the Managing Principal of McCulley/Cuppan Inc., a group he co-founded. Mr. Cuppan has spent 30+ years working in the life sciences with 20+ years providing consulting and training services to pharmaceutical and medical device companies and other life science enterprises. 
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