R Submission Pilot 4 – R Submissions Working Group R Submission Pilot 4 Goal: Utilize alternative methods of distributing a self-contained submission bundle of the Pilot 2 Shiny application with container and web-assembly technologies
GitHub - RConsortium submissions-pilot4-container-to-fda The objective of the R Consortium R submission Pilot 4 Project is to test the concept that a Shiny application created with the R-language can be bundled with novel technologies and transferred successfully to FDA reviewers
R Consortium - Using R to Submit Research to the FDA: Pilot 4 . . . The objective of the R Consortium R submission Pilot 4 Project is to explore the use of novel technologies such as Linux containers and WebAssembly to bundle a Shiny application into a self-contained package, facilitating a smoother process of both transferring and executing the application
Pharma SUG2024 - FDA Pilot 4 (webR Containers) Pilot 4 of the R Consortium Submission Working Group marks a pioneering step in using R for FDA clinical trial submissions, introducing novel technologies like WebAssembly and Containers to elevate submission efficiency and effectiveness
Pilot 4 Learning Session Notes: Container Technology The content in this guide serves as a companion to the Pilot 4 Learning Sessions with members of the Submissions Working Group held on August 1st and August 12th, 2025
Paper ET04 Redefining FDA Submissions: The Future of Interactive R . . . As the consortium anticipates feedback and progresses with Pilot 4, the integration of these technologies is expected to revolutionize clinical trial submissions, paving the way for more efficient, secure, and technologically advanced methods in the future
R submission Pilots to FDA FDA agrees that the initial phase of the R Pilot submission has been completed Seek pilot submission opportunities to other regulator agencies Pilot submission with advanced analysis methods (e g , study design, missing data, Bayesian, etc)
R Submissions Working Group: 2026 Plans and 2025 Success The R Consortium Submissions Working Group’s Pilot 4 project aims to evaluate the use of both WebAssembly and container technologies to bundle R-language based Shiny applications for submission to the FDA, focusing on enhancing reproducibility and ease of review
RConsortium submissions-pilot4-webR - GitHub While this repository positions R as the method for launching a local web server to run the application, other server options should also work For example using Python from the command line: