2KMM

Nowadays R is the talk of everyone in the pharmaceutical industry. A lot is being said about statistical programming (CDISC datasets, TFLs) with R and addressing validation issues. The most important players embraced R in various areas of their …

Validation of the R statistical package has become a hot topic since 2015, when the FDA issued the Statistical Software Clarifying Statement, stating officially that no specific software is required for submissions, and that any tool can be used if …