Whether evidence is imposed as a condition of authorisation or required to support a regulatory submission, it must meet a defined methodological standard that cannot be satisfied retrospectively.
patients in Europe are covered by DARWIN EU's real-world data network, across 18 countries.
European Medicines Agency (EMA), real-world evidence framework to support EU regulatory decision making, Feb 2025 – Feb 2026
We work alongside your team to understand exactly what is being asked, then advise on the approach and methodology that will answer it.
Where you need a protocol and analysis plan, we develop them.
Where your team or another provider is already writing them, we support that work and review the documents before they are submitted.
This covers post-authorisation safety and efficacy studies imposed as conditions of authorisation, evidence for label extensions and new indications, natural history studies that give clinical context to existing data, and external control arms where a randomised trial is not feasible.
