Shaping the Future of FDA Submissions: Pilot 4s Journey with Containers and WebR | ShinyConf 2024 @appsilon_official
Shaping the Future of FDA Submissions: Pilot 4s Journey with Containers and WebR | ShinyConf 2024  @appsilon_official
Uploaded March 2025 | Updated September 2026, 2 weeks ago
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Abstract: 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. This initiative, in collaboration with Appsilon, is revolutionizing the Shiny application packaging and transfer process, establishing a new benchmark that complements the static and extensive documentation.

At the heart of Pilot 4's innovation are WebAssembly and Containers. WebAssembly enables R applications to run almost at native speed in web browsers, bypassing complex local installations and greatly enhancing access. This advancement is crucial for more efficient and secure operation of R-based applications, especially under the strict regulations of clinical trials.

Containers, notably Podman, allow for the same benefits of WebAssembly in terms of portability with the advantage of being a well-established technology. Podman, in particular, is an open-source tool that places a strong emphasis on security, making it an ideal choice to comply with stringent FDA requirements.

Pilot 4 is set to split into two separate submissions, focusing on WebAssembly and Containers, respectively. This approach facilitates a thorough assessment of each technology's capabilities in refining clinical trial submissions.

As the R Consortium awaits feedback on previous pilots and moves forward with Pilot 4, this initiative is expected to significantly expedite clinical trial submission practices. Integrating these advanced technologies underlines the Consortium's dedication to deploying R-based methods for more effective and technologically sophisticated submissions in the future.

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Shaping the Future of FDA Submissions: Pilot 4's Journey with Containers and WebR | ShinyConf 2024

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