Python for Clinical Study Reports and Submission

Learn how to prepare tables, listings, and figures for clinical study report and submit to regulatory agencies, the essential part of clinical trial development.

Authors

Yilong Zhang

Nan Xiao

Welcome

Welcome to Python for Clinical Study Reports and Submission. Clinical study reports (CSRs) sit at the heart of clinical trial development. They bring the design, analysis, and interpretation of a study together in an integrated document.

This book shows how to use Python to plan, build, and automate CSRs, from data and analyses to tables, figures, and listings. We follow the ICH E3 guidance on structure and content and demonstrate practical, reproducible workflows that help you meet those expectations.

Whether you are new to Python or already working in clinical reporting, you will find small, reusable examples you can adopt right away, along with patterns and checklists for organizing work for regulatory submission and effective team collaboration.

This is a work-in-progress draft.

Events

Venue Type Date Materials
R/Pharma Conference Workshop 2025-11-07 Slides