2026 年 5 月 28 日
Which large language model (LLM) should we use?
What's New with GenAI in Regulatory Writing?
Model selection is only part of the equation. Watch our on-demand webinar for an exclusive deep-dive into CoAuthor — covering how to adapt document templates for GenAI, how instructional text informs prompt engineering, and where AI-assisted vs. structured content authoring is most effective. Teams using CoAuthor have seen efficiency gains of up to 40%.

Liam O’Leary
Client Solutions ArchitectLiam O’Leary, PhD, is a Client Solutions Architect at Certara.AI, applying GenAI to bridge science and software for life-sciences teams. He has delivered over 50 CoAuthor demonstrations for pharmaceutical and biotech companies, developed training and workflows for regulatory writers, and partnered across product and consulting to advance Certara’s AI solutions.
常见问题解答
What is AI medical writing software?
AI medical writing software includes any software specifically tailored to supporting medical writing tasks by using rules-based or generative artificial intelligence (AI). AI medical writing software usually assists with writing, checking, or updating text related to source documentation, or aiding the retrieval of information.
Can public LLMs be used for regulated medical writing?
Public LLMs may be useful for non-confidential exploratory work, such as public information synthesis or early ideation. For proprietary clinical and regulatory documents, teams usually need stricter controls over source inputs, internet access, output traceability, and model behavior.
Why not use one LLM for every medical writing task?
Different tasks require different levels of reasoning, precision, and control. A model that performs well for broad synthesis may not be the best choice for conservative document updates or structured content based on predefined templates.
What should teams evaluate when comparing AI-enabled writing solutions?
Teams should assess consistency, traceability, source control, data boundaries, auditability, workflow fit, and how easily authors can review and refine the output. They should also consider whether the solution can support multiple model types without introducing uncontrolled variability.
Where does a closed-loop model fit best?
Closed-loop models are well suited to clinical and nonclinical writing tasks where source material is proprietary and outputs must remain aligned with known inputs. They help reduce uncertainty by limiting the information the model can ‘see’, which narrows the variability in responses and likelihood of errors.
