Our Real-World Evidence Strategy service helps pharmaceutical companies design and execute RWE studies that support market access, regulatory submissions, and commercial positioning. We identify optimal data sources, design study protocols, and develop evidence generation roadmaps.
How our real-world evidence strategy service delivers value to your organization.
RWE study protocol design including population definition, exposure/outcome measures, and statistical analysis plan.
Identification and evaluation of optimal RWE data sources including claims, EHRs, registries, and patient-reported data.
Multi-year evidence generation plan aligned with regulatory milestones, payer engagements, and commercial needs.
RWE studies designed to meet FDA and EMA requirements for regulatory submissions and label expansions.
Comprehensive deliverables that provide actionable intelligence for your team.
A structured methodology that delivers results in four phases.
Identify evidence gaps that RWE can address for regulatory, payer, and commercial needs.
Design RWE study protocols with appropriate populations, comparators, outcomes, and statistical methods.
Identify and evaluate data sources, negotiate data access, and plan data integration.
Develop execution plan with timelines, budgets, vendor selection, and quality control.
We work with claims databases (MarketScan, Optum, Medicare), EHR networks, patient registries, pharmacy data, and emerging data sources like wearable devices and digital biomarkers.
Yes, we design RWE studies that meet FDA Real-World Evidence Framework requirements and EMA requirements for regulatory submissions including label expansions and post-approval studies.
We follow ISPE GPP, ISPOR GPRWE, and FDA RWE Framework guidelines. All studies include protocol registration, bias mitigation, sensitivity analysis, and transparent reporting.
Budget impact models, cost-effectiveness analysis, and ROI frameworks for pharmaceutical market access.
Learn moreValue dossier preparation, payer engagement execution, and negotiation coaching for market access success.
Learn moreFormulary submissions, rebate strategy, and PBM negotiations for pharmaceutical market access.
Learn moreConnect with our team to discuss how our real-world evidence strategy service can support your goals.
Schedule a Consultation