Programming is ubiquitous in applied biostatistics, and most statisticians know a programming language such as R - yet software engineering is still neglected as a skill and undervalued as a profession in pharmaceutical statistics. Why is this a …
Streamlining clinical trial output workflows is a key challenge for clinical studies. Our project leverages Python to link the planned analysis stored in a google sheet LoPO (List of clinical study Planned Outputs) to the study scripts that generates …
Historically building a great SCE for clinical reporting involved selecting a vendor, integrating their product, and supporting a single proprietary language. The shift to report clinical trials using R has had a much broader impact than just …
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 …
The Pharmaceutical industry is adopting new tools and technologies, putting pressure on individuals to learn many new skills in a short period of time. In order to both promote these new ways of working, and to assist those adopting it, at Genentech …
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 …
Roche/Genentech, GSK, Atorus and J&J/Janssen have initiated a collaboration called pharmaverse to bring together a curated subset of open-source R packages to enable clinical reporting (from CRF to eSubmission). Where gaps are identified, new …
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 …