Merck transitioned from a 25-year-old legacy platform to a modern analysis and reporting platform built on Domino, shifting compliance from a manual tracking burden to a native property of their platform infrastructure.
Forcing teams to bridge tool gaps manually with Excel introduces significant human error. Compliance must be a native property of the system design rather than a behavioral requirement.
Merck established fixed data, tool, and compliance requirements before looking at external software, preventing the team from rationalizing platform gaps under sales pressure.
No platform met every Merck requirement. The critical signal is whether a vendor will actively engineer missing capabilities into their core product when challenged.
Maintaining system parity and validating live data across both environments simultaneously is resource-heavy, but it is a fraction of the cost of a questioned FDA filing.
Skeptical statistical programmers rarely believe automated audit trails are real until they watch the system log metadata and track code transformations entirely on its own.
Merck runs one of the pharmaceutical industry's largest statistical programming operations, managing thousands of analytical artifacts under strict regulatory boundaries. Their legacy statistical computing environment, CPI, served the company reliably for 25 years. However, its aging architecture required researchers to manually maintain audit trails, which grew increasingly risky as modern clinical study data formats expanded. The breaking point arrived when Merck realized its scientists were spending too much time proving compliance rather than focusing on core scientific analysis.
To address this, Merck launched a multi-phase transition to build ARP, their new Analysis and Reporting Platform built on Domino. Uday Kiran Kandula, Principal Scientist of Statistical Programming, maps out this journey as a lesson in vendor management. Merck locked in rigid, non-negotiable criteria upfront: data ingestion flexibility across any database, open-source tool integration, and automated audit capture. When initial market reviews surfaced zero out-of-the-box matches, Merck refused to compromise. Instead, they challenged Domino on its process management gaps. By pushing back, Merck transformed a standard vendor relationship into a true development partnership, with Domino adding missing governance and audit features directly into its core product codebase.
Today, ARP connects live clinical data repositories with flexible R and Python environments. Every code transformation automatically creates an audit trail, creating an environment that is always inspection-ready. Uday details the deployment timeline, starting with right-sized proof-of-concept tests, advancing to total study reconstruction using historical datasets, and entering their current phase of running live data in parallel to guarantee system parity before fully decommissioning the old platform.
