The R Validation Hub is a working group within the R Consortium. Contact us at psi.aims.r.validation@gmail.com.

Case Studies

External R Package Qualification Implementation at Merck

in case studies

September 21, 2022

Introduction There has been a growing interest in pharmaceutical industry to use R for clinical trial data analysis and reporting (A&R). Using R for regulatory submission purposes requires careful qualification of R packages given that the open-source packages differ in their quality of development. Many cross-industry initiatives including R Validation Hub and TransCelerate have published framework for qualifying R packages to be used in a regulatory setting (Nicholls, Bargo, & Sims, 2020) (Amoruccio, Lee, & Woodie, 2021).

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R Package Risk Assessment at Novartis

in case studies

May 9, 2022

1 INTRODUCTION Whereas data validation is already a standard precursor to any form of scientific analysis in drug development and the validation of in-house built source code used to generate quantitative deliverables follows standard practices as well, the increasing popularity of open source programming languages like R in this context have created a new type of challenge: the validation of the R packages which are imported and used in the drug submission/ approval projects.

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Automated R Package Validation at Roche

in case studies

April 22, 2022

This case study walks through the automated R package validation process at Roche that utilizes a human-in-the-middle component to reconcile any gaps that arise in the automated metadata checks. The approach balances automation with risk mitigation and encourages in-house package development and iteration by introducing transparency to the validation process. The result reinforces best practices in R programming and package development while ensuring high package quality for use within a regulatory environment.

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Risk Assessment of R Packages at Merck KGaA/EMD Serono

in case studies

February 14, 2022

Introduction Like many other companies, Merck KGaA/EMD Serono has embarked on their journey to enable the use R for regulatory submissions. Following the framework introduced by the R validation hub (Nicholls et al., 2020), we started to develop an algorithm to qualify a CRAN package as a Merck standard package in our GxP environment. In a nutshell: Given the R Foundation’s effort to ensure the validity of base and recommended R packages, these packages are classified as level 1.

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