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In the context of rare diseases, I find the word "rare" somewhat misleading. Taken one by one, each rare disease affects a tiny fraction of the population. Collectively, they affect hundreds of millions of people. In Europe alone, tens of millions live with a rare disease. Most will spend years searching for a diagnosis. And of those lucky enough to receive one, most will spend the rest of their lives without access to a treatment for their condition. We have more patient dat

The Perfect MDR: Does It Exist? In clinical data management, a metadata repository is, at its core, a managed store of standardized data concepts: their definitions, their relationships, their provenance, and the rules that govern how they are used. Ideally, that means capturing not just what a variable is called, but what it means, where it came from, how it connects to a standard, and how it has evolved over time. For pharma companies with a sustained clinical pipeline, th

Data lineage is no longer optional in regulated domains. Making intent explicit ensures data is traceable, interpretable, and trustworthy. In the era of agentic AI, where systems act and make decisions autonomously, understanding why data is transformed or combined is critical to maintain auditability, prevent errors, and ensure that insights remain meaningful and actionable over time.