SHORT Case StudY

Pioneering open-source R and Python FDA submissions to set a new, innovative and efficient standard.

Innovative WebAssembly solution allows R/Python analysis to run directly in browsers, removing software barriers for FDA reviewers, ensuring reproducibility, and streamlining the drug approval process through open-source integration into existing workflows.
Technologies used:

What business problem
did we face?

In the current landscape of the FDA submission process, the use of SAS software plays a dominant role, while examples of using open-source tools such as R and Python are scarce. This disproportion leads to a lack of well-established practices and standards, which in turn limits the exchange of knowledge and experience between organizations. The absence of publicly available examples of using R and Python in submission procedures results in a stifling of innovation and collaboration within the industry. Organizations, lacking a solid foundation to emulate or confidence in best practices, are reluctant to take risks on their own, which from the perspective of the entire industry, makes it difficult to introduce innovative solutions. A significant issue in the current submission process is ensuring result reproducibility. For the FDA review process to be reliable, it is necessary for reviewers to be able to run analyses in exactly the same way as the submitting team. When submissions are done in an open-source language, such as R, reviewers’ might have trouble reproducing the submitter’s environment. This significantly increases the risk of discrepancies and errors, underscoring the importance of developing solutions and standards that facilitate reproducibility in the submission process.

The solution we

To tackle these challenges, we implemented an innovative solution using WebAssembly, enabling R and Python code to run directly in web browsers. This eliminates the need for FDA reviewers to install any software, drastically cutting down barriers to reproducibility and streamlining the submission review process.

Our solution integrates into the FDA workflow, catalyzing a shift towards open-source technology and providing a scalable, secure platform that guarantees analysis replication by FDA reviewers. It marks a critical step in advancing innovation, standardization, and collaboration within the pharmaceutical industry, leading to a more transparent and efficient drug approval process.

The impact of our solution
and its ROI

Contact Us

We are approaching the final stages of submitting a RConsortium pilot project powered by WebAssembly technology.


“It will minimize, from the reviewer’s perspective, many of the steps that they had to take to get the application running on their machines.” - No installation required: how WebAssembly is changing scientific computing (

Eric Nantz

Eli Lilly

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