Introduction
Welcome to the R Consortium R Submission Working Group!
The R submission working group is a cross industry pharma working group focusing on improving practices of R-based clinical trial regulatory submissions.
You can view previous meeting minutes with links to recorded sessions here
Our Mission
- Easier R-based clinical trial regulatory submissions today
- by showing open examples of using current submission portals
- Easier R-based clinical trial regulatory submissions tomorrow
- by collecting feedback and influencing future industry and agency decisions on system/process setup
Please visit the How to Join page for complete details on joining our working group.
Our Pilots
The R Submissions Working Group has conducted a series of pilot projects to demonstrate and advance best practices for R-based regulatory submissions to the FDA. Each pilot builds on the last — exploring submissions packages, ADaM datasets, TLFs, novel technologies like WebAssembly and Dataset-JSON, AI-assisted analysis, and synthetic clinical data. Together they form a growing body of evidence that R is ready for the full regulatory submission workflow.
Timeline
Hex Stickers
Seven pilots. One mission. Open-source R for regulatory submissions.
