Authoring regulatory documentation using AI/ML and LLMs

2:15 PM - 2:35 PM

Writing regulatory documents such as clinical study report (CSR), Safety narratives, Plain language summary (PLS), Informed consent form (ICF) and converting post-text to in-text tables are highly manual and time consuming. These activities require other medical writers to perform quality control. A significant amount of information to these documents comes from other existing source documents such as Protocol, SAP etc. Technology can be effectively used to create a decent draft of these documents. We can discuss in this presentation about one such approach by utilizing emerging technology such as machine learning and Natural language processing (ML/NLP) will effectively reduce the manual efforts. The approach also brings some standardization to the document authoring process. Medical writers can focus more on discussion points, interpretation of study results and science behind these regulatory documents.