External comparator studies have emerged as a critical evidence-generation pathway for pharmaceutical and biotech companies seeking to address evidence gaps when RCTs are not feasible. This white paper provides a comprehensive overview of study design, data requirements, regulatory expectations, and emerging innovations that are shaping the future of comparative evidence. It offers practical guidance for sponsors aiming to create credible, defensible evidence strategies that support both approval and market access.
Augment your clinical studies with a control arm from real world data to add comparative context. Generate impactful evidence to support successful market authorization and reimbursement.
IQVIA is using vast quantities of data in powerful new ways. See how we can help you tap into information from past trials, patient reported outcomes and other sources to accelerate your research.
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