Breaking The Mold: How R Is Revolutionizing CSR Generation

The CDISC Standard Data Tabulation Model (SDTM) is essential for the FDA-required Analysis Data Model (ADaM) and Tables, Figures, Listings (TFLs) in clinical trial submissions. Traditionally, the pharmaceutical industry has used SAS, a statistical analysis software, for Clinical Study Report (CSR) submissions. This leads to increased costs and process bottlenecks. However, the open-source statistical programming language R is becoming more popular in the life sciences sector due to its cost-effectiveness, inclusivity, and collaboration. In 2015, the FDA stated that it doesn't mandate the use of any specific software for statistical analyses, leading to the creation of R packages to assist with compliance and clinical research. Pharmaceutical companies such as Novo Nordisk and the R Consortium have successfully submitted ADaM datasets and TFLs using R, demonstrating its enhanced visualizations, increased usability, and wider application.