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 …
Continuous integration (CI) and continuous delivery (CD) are playing a pivotal role in ensuring that R projects in Pharma meet the highest quality standards. Particular focus is placed on ensuring that packages are fit for purpose both on internal …
On Nov 22nd, 2021, the R Consortium R Submissions Working Group successfully submitted an R-based test submission package through the FDA eCTD gateway. The submission package has been received by the FDA staff who were able to reproduce the numerical …
In this talk, we would like to provide updates on the four biopharmaceutical industry focused R consortium cross-industry working groups. These working groups have a similar overall objective to support the use of R within the biopharmaceutical …