Statistical Analysis and Pathway to a Risk-based Assessment of R packages at Merck KGaA/EMD Serono


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 a nutshell If an R package passes the installation qualification and successfully executes available tests, the package will be made available to the user. Then, an automated risk assessment of R packages is performed based on the test coverage score (more is better) and the riskmetric score generated from the meta-information (smaller is better). If pre-defined thresholds are fulfilled, the package is qualified as Merck standard package, otherwise an explicit (manual) risk assessment is needed. In this presentation, we introduce our pathway to a risk-based assessment of R packages at Merck. We provide relevant details on the statistical analysis which led to the definition of thresholds supporting a robust classification of CRAN packages as Merck standard packages. We want to inspire other companies and seek feedback from the community.

Presented at 2021 Conference