Real World Evidence Generation

Optimising real world data use to drive effective outcomes

Real world evidence (RWE) is central to regulatory approval, market access negotiations, and sustained value demonstration. ICON designs and delivers real world evidence studies that meet regulatory expectations, resonate with payers and answer complex clinical and commercial questions.

We take a science‑led, operationally integrated approach, grounded in early planning, rigorous data evaluation and continuous alignment with evolving stakeholder evidence needs.

Evidence generation strategy

Effective real world evidence generation starts with integrated planning as part of the overall evidence strategy and evolves dynamically across the lifecycle from proof of concept through post‑approval.

ICON plans real world evidence early and builds it progressively across the asset lifecycle:

Early assessment of appropriate real world data sources during study design and feasibility
Peri-approval studies extending clinical trial outcomes into real world use
Post-approval studies supporting safety, effectiveness and label expansion
Ongoing evidence enabling HTA, reimbursement and lifecycle optimisation

This lifecycle led approach ensures continuity, methodological consistency and maximum reuse of evidence across regulatory, access and commercial needs.

Regulatory and HTA aligned by design

ICON delivers real world evidence aligned to the requirements of global regulators and HTA bodies. We design studies to support post‑authorisation commitments, label expansion, and reimbursement submissions - anticipating agency expectations and generating robust, defensible evidence.

RWE in practice

We design and deliver real world studies across the full evidence spectrum, including registries, pragmatic Phase 3b/4 trials, and long‑term follow‑up, as well as claims and EHR analyses, external control arms, and comparative effectiveness research.

Our hybrid approaches link primary and secondary data using secure tokenisation and incorporate patient‑reported outcomes and digital data, enabling longitudinal insight across care settings.

Data and analytics

Our global data ecosystem underpins the generation of regulatory‑grade evidence. We combine access to large‑scale claims, EHR, and registry datasets with secure patient‑level linkage and advanced analytics, including AI‑enabled methods, to support study design, execution, and interpretation.

Supporting medical affairs

We support medical affairs teams in addressing evidence gaps across the product lifecycle, from post‑authorisation safety studies and early access programmes to patient‑centred outcomes research. Delivery is led by dedicated RWE specialists with experience across 20+ therapeutic areas.