Real-World Evidence (RWE)

Real-world evidence uses data generated outside of traditional clinical trials to inform development, regulatory, and commercial decision-making. RWE can complement clinical trial data by providing insights into real-world use, safety, and outcomes.

RWE strategies require careful consideration of data sources, study design, and analytical methods to ensure relevance and credibility. Alignment with regulatory and scientific expectations is critical.

When used appropriately, RWE supports broader evidence generation across the product lifecycle.

Real-world evidence activities often include:

• RWE strategy development

• Study design and protocol development

• Data source assessment

• Analysis and interpretation

• Integration with regulatory and clinical programs