Teams in medical writing are being pulled in every direction. Internal experts see how much pressure that they are under to move faster, improve quality, and manage rising document volumes. AI holds the potential to help, but only if the rollout is planned with purpose.
That’s where a structured AI medical writing pilot comes in. It provides a chance to validate the impact of generative AI in real-world workflows while building internal buy-in and reducing risk at the same time. TrialAssure recently hosted a webinar focused on exactly this process: how to start with clarity, reduce false starts, and turn a small win into a larger transformation.
Watch the on-demand webinar now.
Start with a Use Case That Matters
One of the first decisions that shapes a successful pilot is choosing the right document type. Teams are seeing the strongest results by starting with high-volume documents like informed consent forms (ICFs), clinical study reports (CSRs), and patient narratives. These are labor-intensive and time-consuming, making them ideal for showing quick wins.
In a recent engagement, TrialAssure and MMS partnered to improve ICFs using AI. The results were powerful (see the case study). Drafting time dropped by 80 percent, readability improved, and ethics and compliance remained intact. Most importantly, the solution gave medical writers more time to focus on higher-level content planning and quality review.
Avoid the Common Pitfalls
Pilots fail when goals are unclear, timelines are not measured, or platforms are adopted without input from the actual medical writers. TrialAssure’s pilot framework avoids these issues by guiding Sponsors and CROs through a three-step process: planning, implementation, and evaluation.
This includes benchmarking current timelines and effort, setting targets for speed and quality, and training users early. It also means preparing for change management. AI can improve efficiency, but it requires trust and confidence. When the medical writers using the tool are involved from the start, adoption improves.
Pick the Right Pilot Format
TrialAssure sees two main paths to getting started:
- Hands-on pilots are best for teams ready to explore the technology directly. Writers generate drafts, provide feedback, and compare results to their usual workflows.
- Hands-off pilots are ideal for groups with limited bandwidth. TrialAssure configures the tool, produces sample drafts, and presents metrics and quality evaluations based on your templates and guidelines.
Both formats are structured to reduce internal friction and give stakeholders the clarity they need to move forward.
Let Results Speak for Themselves
In one case, a biotech organization used TrialAssure’s LINK AI to streamline clinical document creation. What used to take hundreds of hours now took tens. That time savings came with improved clarity, higher writer satisfaction, and easier cross-functional collaboration. With one document type complete, the team expanded into CSRs, IBs, and other safety documents (see the case study).
It’s a reminder that AI is best viewed as a tool to enable better work, not just faster work. When medical writers spend less time formatting and rewording, they can spend more time thinking, refining, and reviewing.
Avoid Internal Bottlenecks
Many life sciences organizations face pressure to move fast with AI. Building internal solutions may seem like a way to gain control, but without dedicated product teams, ongoing validation, and constant alignment to evolving global regulations, those efforts often stall. In fact, recent industry research shows that more than 30 percent of AI initiatives delay impact by three to five years. Some never reach production at all.
Common pitfalls include unclear ownership, under-resourced development, and a lack of user trust. Numerous added risks of building AI internally were outlined in a recent whitepaper, in detail. In the medical writing space, these gaps often lead to AI tools that create more work than they solve, like delivering draft outputs that require full rewrites, or missing key data elements required for compliance.
Pilots built around collaboration can reduce that risk. They bring structure to experimentation, let teams evaluate performance across real document types, and provide a clear framework for measuring utility, speed, and consistency. A strong pilot can uncover insights that guide broader adoption, even if your long-term vision includes a mix of internal and external solutions.
The key is to move forward with purpose.
How to Get Started
Launching a successful pilot begins with a single conversation. What documents are the most time-consuming? Where is the writing process slowing down? How is your team measuring performance?
By answering these questions early, you will be better equipped to choose the right tools, involve the right people, and show results that matter. If your team is looking to pilot a medical writing AI tool, request a demo here.
