LinkedIn·Friday, 7 August 2026·18d ago
Real-world data is only as valuable as it is trustworthy. In her latest piece for PharmaLive, CluePoints Senior Strategic Consultant Sophie…
CluePoints
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Real-world data is only as valuable as it is trustworthy.
In her latest piece for PharmaLive, CluePoints Senior Strategic Consultant Sophie Henderson frames three shifts reshaping clinical research at once: the rise of real-world data, growing regulatory backing for risk-based approaches, and AI that unlocks insights at new scale.
Her point is that they're interlocking, not separate. As RWD increasingly supports regulatory submissions, its integrity can't be assumed. Risk-based quality management and centralized statistical monitoring offer a proven way to scan large, messy datasets for the outliers that matter, while AI takes on curating data that was never designed for clinical research.
And as Sophie makes clear, this isn't about buying one tool. It's about alignment, adapted processes, and upskilling teams so new approaches actually get adopted.
Read the full article here: https://hubs.ly/Q04sd-ZY0
#RBQM #RealWorldData #RealWorldEvidence #DataIntegrity #ClinicalResearch
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