This insight guide analyzes 46 global regulatory and methodological guidelines to assess how feasibility criteria for real-world evidence studies are defined and applied. It identifies significant gaps and inconsistencies in areas such as data quality, operational methods, reporting templates, and multi-country assessments. The document presents a detailed mapping of feasibility criteria across regions and regulators, highlighting where guidance is incomplete or unclear. IQVIA proposes mitigation strategies, including standardized checklists, structured frameworks, and regulator-aligned methodologies, to improve transparency, study design, and data source selection. The guide supports more consistent, fit-for-purpose RWE generation.

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