Statistical Computing Environment at Merck

Merck ran a 25-year-old legacy statistical computing platform (CPI) requiring manual audit-trail maintenance, which grew increasingly risky and resource-intensive as clinical data formats expanded, pulling scientists away from actual science. Merck built a new Analysis and Reporting Platform (ARP) on Domino, first setting non-negotiable requirements (flexible data ingestion, open-source tool support, automated audit capture) and, when no platform met them all, partnering with Domino to engineer the missing governance features, then rolling out via proof-of-concept, historical data reconstruction, and parallel running with live data. ARP now connects clinical data repositories with R and Python environments and automatically generates audit trails for every code transformation, achieving continuous inspection-readiness with less manual compliance burden. The page's core quote: 'When statistical programmers must manage compliance by hand, the underlying architecture has failed.'

Domino Data Lab is an enterprise MLOps platform built for regulated industries — the sanctioned sandbox where biopharma teams run reproducible experiments under GxP/21 CFR Part 11 guardrails.

This sits in the Design & Stress-Test stage of the AI use-case lifecycle: Named examples from the tools pharma teams use to scope, prototype and benchmark an AI use case before committing to build it — data-catalog, sandbox and evaluation platforms.