Real-world evidence that answers the question regulators and payers will actually ask
We help teams decide which real-world questions matter, which data sources can credibly answer them, and how the resulting evidence will be used — then we design and execute the studies, from registries and claims to AI-assisted social listening.
Strategic advisory
Before any deliverable is scoped, our consultants work with your leadership to answer the questions that determine whether the evidence will change a decision.
- RWE strategy and evidence-gap prioritisation across the lifecycle
- Data-source feasibility and fit-for-purpose assessments
- Regulatory and HTA acceptability reviews of proposed RWE designs
- Patient-voice and unmet-need intelligence programmes
Evidence generation capabilities
Retrospective Database Studies
Study design, protocol development and analysis using EHR/EMR, insurance claims and registry data.
Prospective Observational Studies
Non-interventional study design, site coordination and statistical analysis.
Patient Chart Review & Abstraction
Structured medical-record abstraction and clinical annotation with quality-controlled data capture.
Physician & Patient Surveys
Survey design, fielding and analysis to quantify treatment patterns, preferences and burden.
External Control Arms
Real-world comparators to contextualise single-arm trial data for regulators and HTA bodies.
Rare Disease Research
Natural-history studies, registry analyses and evidence synthesis where trial data are scarce.
Wearable & Digital Data Analysis
Analysis of sensor, app and digital-biomarker data alongside conventional real-world sources.
Evidence Synthesis of RWE
Systematic reviews and meta-analyses of real-world studies to support label and access claims.
AI-assisted strategic analysis
Not every project needs it. For the engagements below, our consultants draw on in-house AI tools to analyse faster and more consistently — and you receive the insight as a strategic report with recommendations.
Real-world data feasibility assessment
Before a study is designed, we use in-house AI tools to screen candidate data sources — EHR, claims, registries, digital — against your research question for population coverage, variable availability, follow-up and data quality, and recommend the fit-for-purpose source with our consultants' judgment attached.
RWE acceptability & evidence-gap review
For studies intended to support regulatory, HTA or payer decisions, we benchmark the proposed design and existing real-world evidence against what FDA, EMA, HTA bodies and payers have previously accepted — and prioritise the gaps worth closing.
Questions clients ask about Real World Evidence Strategy
Real-world evidence is strongest when it is designed alongside our HEOR & Global Market Access Strategy, Competitive Intelligence and Scientific Communications capabilities.
What real-world data sources do you work with?+
Insurance claims, EHR/EMR, disease and product registries, patient chart abstraction, physician and patient surveys, wearables and digital biomarkers — selected after a fit-for-purpose feasibility assessment.
Will regulators and HTA bodies accept our RWE study?+
Acceptability depends on design, data quality and transparency. We benchmark proposed designs against FDA, EMA and HTA precedents and follow HARPER, STROBE and ISPOR/ISPE good-practice guidance.
Can you build an external control arm for a single-arm trial?+
Yes. We design real-world comparator cohorts, apply population-adjustment methods and document feasibility so the comparison withstands regulatory and HTA scrutiny.
How long does a retrospective database study take?+
Typically 3–6 months from protocol to report, depending on data access, cohort complexity and the number of outcomes; feasibility assessments take 3–4 weeks.
Scope a Real World Evidence Strategy engagement
Share your objectives, timelines and target markets. We respond within one business day with next steps.