EMD Serono

The use of R in submissions to healthcare regulators presents challenges as the quality of packages must be ensured, and evidence of this quality must be readily available. The Regulatory R Package Repository Working Group aims to tackle these issues …

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 …