IH02 - Accelerate Authoring Across R&D Documents: AI Tool Demos for CSR, CTD, Non-Clinical & CMC
Information
This session presents practical approaches to AI-orchestrated authoring and quality control for regulatory and medical writing across the R&D document lifecycle, spanning clinical, non-clinical, quality, safety, labeling, and regulatory submission–related documents.
We demonstrate how teams can work in familiar environments—such as a Microsoft Word add-in and a web portal—while automating up to 90% of first-draft content in alignment with regulatory guidance. The approach streamlines review comment incorporation, document finalization, quality control, and subsequent updates to accelerate submission timelines.
The workflow integrates with enterprise systems, including Veeva RIM, supporting the end-to-end lifecycle of regulatory submissions alongside existing document management and review processes.
Finally, we introduce an R&D document-network model for change intelligence, enabling automated change detection, dependency mapping for impact assessment, visible change lineage, and downstream propagation—supporting cross-document consistency and scalable QC.
