Real-world evidence is now used to answer a wide range of questions, from how a treatment performs against current care to how a disease behaves and what patients face without one, and the methodological standards applied to it are rising.
A study whose design, population or outcomes do not fit the question being asked limits what it can show, regardless of the quality of the data behind it.
global RWE solutions market in 2025, projected to reach $11.9bn by 2035
Global Market Insights, Real World Evidence Solutions Market Size & Share 2026-2035, Feb 2026
of real-world evidence research topics assessed by the EMA in 2025-26 were found not feasible with the available data.
EMA, Real-world evidence framework to support EU regulatory decision-making: 4th report, February 2025 to February 2026
We design real-world studies around what you need to show.
That might be how a treatment performs against current care, or simply what a disease, treatment pathway or patient experience looks like in routine practice.
We start by framing your research question, before any data source is selected.
Where the question calls for a comparator, we choose the strategy, whether real-world cohorts, indirect comparisons or external controls, and specify the methodology.
We also assess candidate data sources for fitness for purpose, draw on existing evidence where it strengthens the design, prepare the study protocol, and help develop or review your statistical and qualitative analysis plans.
