AI-Powered Document Authoring in Clinical Research
This tutorial explores how Thermo Fisher Scientific leverages AI-powered document authoring to enhance efficiency, quality, and scientific rigor across regulatory medical writing. We will present real-world use cases, governance considerations, validation approaches, and implementation lessons from enterprise deployment.
The session positions AI not as a replacement for the medical writer, but as an augmentation tool that strengthens scientific reasoning, clarity, compliance, and reproducibility. Attendees will gain practical insights into prompt strategy, structured authoring workflows, human-in-the-loop review models, risk mitigation, and quality control frameworks.
We conclude with a forward-looking vision for AI-enabled knowledge workflows and the evolving role of the medical writer as scientific curator, quality steward, and strategic communicator.
Affiliation:
Abhishek Patil (PPD™ clinical research business of Thermo Fisher Scientific)
Role/Title:
Associate Medical Writing Director
Short Bio:
Abhishek Patil is an Associate Medical Writing Director and AI Implementation Lead at Thermo Fisher Scientific, where he leads enterprise AI initiatives within regulatory medical writing. With over 15 years of experience in global drug development and regulatory submissions, he brings deep domain expertise to the responsible integration of AI into regulated clinical workflows.
He focuses on structured authoring frameworks, human-in-the-loop review models, and governance systems designed to ensure quality, compliance, traceability, and reproducibility in AI-assisted document development. His work centers on the practical implementation of AI-powered document authoring in clinical research, integrating prompt strategy, validation methodologies, risk mitigation controls, and quality oversight into production environments.
Abhishek is committed to augmenting scientific expertise with AI—positioning technology not as a replacement for the medical writer, but as a rigor-enhancing tool that strengthens analytical reasoning, clarity, efficiency, and scientific integrity across clinical development programs.