Sep 29, 2026
Between ICH E6(R3) and AI, clinical data management is moving upstream. At SCDM this year,...
Aug 30, 2026
A Data Monitoring Committee can be one of the most important oversight structures in a...
Aug 25, 2026
When sponsors evaluate Bayesian vs frequentist clinical trials, the discussion often starts with two competing...
Aug 23, 2026
Medical device trials often require a different statistical mindset from drug trials. While the principles...
Aug 06, 2026
In regulatory submissions, the statistical programmer is often seen as the person who produces datasets...
Aug 06, 2026
Integrated summaries are among the most demanding deliverables in clinical development. They require sponsors to...
Jul 29, 2026
A regulatory submission package is not judged only by whether the datasets validate. Reviewers also...
Jul 28, 2026
ADaM dataset creation is one of the most important parts of clinical trial statistical programming....
Jul 07, 2026
The discussion around SAS vs R in clinical trials is often framed as a technology...