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A case study in accelerating regulatory and safety document development through GenAI augmented structured content authoring

Authors: Akanksha Rai, Shruti Diggavi, Amita Sawhney, Bersabeh Boroumand, Elizabeth Theron, Joanna Chen, Jonathan Mackinnon, Nhlalala Mavundza, Reagan Mahajan, Mati Kargren

As the clinical trial industry evolves, generative artificial intelligence (GenAI) and machine learning are being rapidly adopted within clinical trial activities to support trial design, planning, execution, and regulatory submissions. Traditional authoring practice for clinical and regulatory documents involves unstructured content development, an approach that limits the opportunity to use GenAI efficiently. The industry is pivoting towards a more systematic approach, employing structured, reusable content that supports digital data flow and GenAI functionality. Incorporation of GenAI into the day-to-day work of medical writers remains an area of intense focus. Within Parexel medical writing services, the implementation of structured content authoring is fully adopted and being used on a wide variety of safety and regulatory documents. This is reflected in survey results from safety medical writers reporting their authoring experiences on the structured content platform. Although GenAI augmentation remains in its infancy, in this article, we describe our efforts towards implementation, including the approach to prompt development and advantages for augmenting medical writing workflows.

Medical Writing. 2025;34(4):66–72 | https://doi.org/10.56012/rfbb3298

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