DateSeptember 7, 2023 LocationBoston, MA

Atorus is attending and presenting at PHUSE SDE – Massachusetts. Learn more about our presentation and request a meeting using the form to the right.

Stopping the ‘R Isn’t Validated’ Statement.
Validation of Open-Source Packages from CRAN, Challenges, Processes and Implementation into Different SCEs

Thursday, September 7th, 9:30-10:00 AM

Presented by:
Mark Penniston
Atorus CEO 

As of 8 May 2023, the CRAN package repository features 19,476 available packages. Additionally, there are 27 documents with the word ‘validation’ on the FDA guidance search and 5,879 entries on the FDA website. This subsets to 1,373 results when the search is enhanced to ‘software validation’. With the challenge of so many packages and a multitude of discussions on software validation, we describe the process and results of validating open-source R packages on CRAN. We achieve a quality-controlled, reproducible and deployable process and product for clinical trial programming and beyond.

This presentation will discuss the challenges faced and the interpretation of guidance documents and leverage other external group consortiums to debunk the myth that R cannot be a validated programming language.

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