This fact sheet explains how Real-World Evidence (RWE) enables smarter diagnostic decision-making by supporting the development, validation, and adoption of diagnostic tests in real-world settings. RWE studies leverage observational and non-interventional designs aligned with standard care, enabling cost-effective and scalable data collection while minimizing patient burden. By integrating existing secondary data and prospective site-based approaches, organizations can generate robust, high-quality evidence that meets regulatory and payer requirements. RWE supports multiple use cases across the diagnostic lifecycle, including clinical validation, post-market surveillance, and health economics analysis. IQVIA enhances this process through data-driven site selection, integrated data capture

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