A clinical sponsor knew its approach to risk-based quality management wasn't sustainable. The team was buried in the mechanics of the work: preparing data, loading files, managing signals. There was no time left to focus on what the results meant or how to act on them. The analysis was getting done, but the thinking behind it wasn't.

The sponsor faced a choice. Treat this like a typical IT project and bring in consultants to write requirements and code, or take a different approach, one that started with business context rather than technology.