Protocol writing is the backbone of clinical research documentation. Every clinical trial begins with a protocol—a definitive guide that outlines the study’s rationale, design, procedures, and regulatory framework. Medical writing firms, particularly smaller ones, are often the unsung heroes behind these documents. They are responsible for transforming raw trial information into a comprehensive, regulator-ready protocol. Yet for many, the process remains stubbornly manual, time-intensive, and dependent on a handful of overburdened experts.

As protocol complexity rises with the inclusion of adaptive designs, multi-arm studies, and expanded safety monitoring, so too does the burden on small writing teams. For these firms, the bottleneck is not quality or expertise—it’s capacity. Even highly experienced writers cannot meet tight sponsor timelines if the workflow itself is fragmented.

Enter automation. For lean teams, the adoption of structured, centralised tools can be the difference between declining new work and scaling up their service offering. In this case study, we explore how a fictional but representative medical writing agency overcame its growing pains with the help of a document automation platform—freeing up time, improving consistency, and regaining control of its project timelines.

The Strain on Small Teams: Too Much Work, Too Little Time

A firm of five writers can handle just so much. When the pipeline is filled with overlapping protocols, each with differing requirements, amendments, and sponsor preferences, projects begin to bleed into each other. Errors crop up. Teams stretch deadlines. Client relationships fray. For many boutique medical writing firms, this is an all-too-familiar reality.

Our case example, ClearPath Medical Writing, had earned a strong reputation for clarity and scientific precision. Their team regularly produced protocols for academic sponsors, CROs, and investigator-led studies across the UK and EU. But as their client list grew, so did the documentation demands. Their writers were juggling up to three protocols at a time—each requiring dozens of hours for information collection, formatting, consistency checking, and amendment integration.

Crucially, many elements of their workflow were repeated manually: copy-pasting from spreadsheets into Word documents, reconciling changes across outdated versions, and reformatting to match sponsor templates. None of this was billable. Every hour spent on formatting or rechecking consistency was an hour lost to high-value thinking and writing.

Why Automation Mattered for ClearPath

At first, the team was hesitant about adopting automation. Would it force them into rigid templates? Would it reduce the writer’s craft to filling in boxes? But the tipping point came after a particularly stressful month in which two protocols required back-to-back amendments within a week. After an internal review, they identified that over 40% of their time was being spent on non-writing tasks—formatting, cross-referencing, error-checking.

ClearPath implemented a pilot of the Momentum platform for their next sponsor project—a Phase II protocol for a decentralised respiratory study involving multiple digital assessments and patient-reported outcomes. Here’s what changed:

Structured Data Collection Replaced Back-and-Forth Emails

Instead of gathering fragmented information through email chains and sponsor calls, the team used Momentum’s central forms to collect trial details in a consistent, structured way. This drastically cut down the time spent chasing missing data and aligning terminology.

Template-Driven Protocol Drafting in a Fraction of the Time

Using pre-approved protocol templates embedded in the platform, the core draft was generated in under 48 hours after form completion. Writers retained full control over the language and could override or expand sections as needed, but the structural skeleton was already complete—headings, regulatory text, formatting, and tables in place.

Live Syncing Across Amendments and Versions

When a mid-draft change came through—shifting the primary endpoint and related assessments—the update was made once in the central dataset. The new protocol was re-generated within minutes, already aligned with the revised objectives and schedule. No copy-paste errors. No redundant proofing.

Team Collaboration Without Chaos

Each writer could work on separate sections in parallel, while the platform tracked changes and versions in real time. The lead writer retained oversight without needing to manually reconcile edits. Audit trails helped with QA reviews, especially for sponsor scrutiny.

Outcome: Scaling Capacity Without Compromising Quality

By adopting automation, ClearPath were able to:

• Reduce protocol drafting time from three weeks to less than five business days
• Complete two additional projects within the same quarter without needing to hire additional staff
• Increase client satisfaction by delivering ahead of schedule, with cleaner drafts and fewer requested edits
• Build a protocol library within the platform, allowing the team to draw on past approved language to accelerate future drafts

Perhaps most importantly, the writers reported higher job satisfaction. Instead of spending hours wrangling tables and cross-referencing eligibility criteria across documents, they were able to focus on the science, tailoring the language, and ensuring clarity—what they were hired to do in the first place.

Reframing What It Means to Be a Small Team

Automation didn’t make ClearPath bigger. It made them sharper. With a lean team and a growing reputation, they’re now able to take on more complex trials—without fearing that a single amendment will derail the timeline.

The firm now pitches its services with confidence, knowing that they can accommodate quick turnarounds and large documentation packs without overstretching. They’ve even begun using Momentum to pre-populate standard trial documents beyond the protocol: patient information sheets, site training logs, and even the IRAS form.

This isn’t about replacing writers. It’s about removing the burdens that keep them from writing.

Considerations for Other Writing Firms

For small writing teams considering a similar shift, a few lessons stand out:

• Start small. Piloting a single project allowed ClearPath to adapt gradually and build internal confidence in the tool.
• Don’t fear the template. Platforms like Momentum are designed with customisation in mind—automating structure while preserving author flexibility.
• Document your process. As workflows become faster, it’s essential to maintain strong QA and document review steps. Automation accelerates delivery but doesn’t replace the need for human oversight.

Conclusion: Giving Writers Their Time Back

Small medical writing firms are uniquely positioned to deliver expert, personalised service. But without the right tools, they risk drowning in the operational load of their own success.

By automating protocol development, teams like ClearPath have shown that you don’t need a big team to make a big impact. With the right infrastructure, even a five-person firm can deliver at the speed—and quality—of a much larger operation.

In a competitive market, that might be the ultimate differentiator.