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The Provenance Gap: Why Real-World Data Passes Technical Review and Fails Regulatory Review A dataset arrives. The technical review goes well. Field completeness is high. Record counts meet the requirement. The mapping runs cleanly. Everyone signs off. Eighteen months...
What ICH M14 Changes About How Sponsors Choose Real-World Data Sources Real-world data sourcing used to happen after the protocol was written. A team defined the research question, drafted the design, then went looking for a dataset that could answer it. Procurement...
What Makes Real-World Data “Research-Ready”?: A Fitness-for-Use Framework Every real-world data (RWD) source looks strong on a slide. The patient counts are large. The therapeutic areas are broad. The logos are familiar. On paper, one dataset looks much...
Speed, Accuracy, and Trust in Real-World Evidence: A Researcher’s View Real-world evidence is only as good as the data behind it, and speed, accuracy, and trust are usually treated as trade-offs. A researcher working with the BEKnetwork recently described what...
Real-World Evidence Doesn’t Need More Data. It Needs Better Data with Better Reach. The real-world evidence industry has spent two decades getting better at one thing: extracting more data from the historical record. Claims databases have grown deeper. EHR...
