Real-World Evidence (RWE)

Real-world evidence uses data collected outside traditional interventional trials: electronic health records, claims, registries, and observational cohorts that reflect use, outcomes, and effectiveness in routine care. Viltis helps life sciences teams plan RWE studies and analyses that are fit for the decision at hand, including label expansion support, post-marketing commitment planning, HEOR inputs, or internal development prioritization. We are clear about what RWE can and cannot replace in a regulatory package. A precise research question comes first; data fishing comes last.

Good RWE work starts with data source feasibility and a protocol or statistical analysis plan that addresses confounding, missingness, and endpoint ascertainment. We help teams choose between retrospective chart review, prospective observational designs, and hybrid approaches that combine trial and real-world elements. Privacy, consent or waiver pathways, and data use agreements are handled as study prerequisites, not afterthoughts. When EHR extract quality is uneven, we pressure-test coding definitions and look-back windows before analysis begins.

Execution support includes vendor or data partner oversight, quality checks on extract completeness, and interpretation that stays honest about residual bias. When RWE feeds regulatory or HTA discussions, we help document methods and limitations in language reviewers expect. We do not invent effect sizes or overstate causal claims the design cannot support. Cross-functional review with clinical, epidemiology, and medical writing keeps the final report consistent with what the data actually show.

RWE projects also need operational discipline similar to interventional studies: version-controlled protocols, audit trails for analytic code, and clear ownership of interim outputs. That structure makes results reusable for later submissions or publications without rebuilding the study story from scratch. When the same dataset may support both internal decisions and external briefings, documentation standards should match the stricter use case from the start.

Real-world evidence support commonly covers

• RWE question framing and fitness-for-purpose review
• Protocol and SAP development for observational studies
• Data source feasibility and partner selection
• Privacy consent and data use agreement planning
• Analysis interpretation with limitation statements
• Regulatory or HTA briefing support for RWE packages
• Hybrid trial and RWE design coordination

If you need RWE that decision-makers can actually use, without overselling causal certainty, we help design and oversee the work with the same discipline you would expect from interventional clinical operations.