Real-World Evidence & Patient Outcomes
Defensible RWE for label expansions and payer submissions.
Harness real-world data from claims, EHRs, patient registries, and wearables to generate evidence that supports label expansions, post-market commitments, and health technology assessments — with rigorous methodology, transparent assumptions, and defensible results.
Real-world evidence has moved from a supplementary data source to a central pillar of regulatory and payer decision-making. FDA now accepts RWE to support label expansions and post-market commitments. Payers require HEOR evidence packages that demonstrate clinical and economic value in real-world populations. Health technology assessment bodies demand comparative effectiveness analyses that go beyond randomized trial data. Bracy Analytics brings the methodological rigor and technical infrastructure to generate RWE that meets these standards — from study design and data source selection through causal inference methods, outcome modeling, and evidence package preparation. Every analysis is documented with full transparency about data sources, assumptions, and limitations.
What We Deliver
Comparative Effectiveness Research
Rigorous comparative effectiveness analyses using claims, EHR, and registry data — with appropriate confounding control methods and sensitivity analyses to support regulatory and payer submissions.
Propensity Score Matching & Causal Inference
Advanced causal inference methods including propensity score matching, inverse probability weighting, instrumental variable analysis, and difference-in-differences — with full methodological documentation.
Patient-Reported Outcome (PRO) Analytics
Analysis of PRO data from clinical trials, registries, and digital health platforms — including psychometric validation, responder analysis, and meaningful change threshold estimation.
HEOR Modeling & Payer Evidence Packages
Health economic and outcomes research modeling including cost-effectiveness analysis, budget impact modeling, and payer evidence packages designed for formulary and coverage submissions.
Post-Market Surveillance Analytics
Pharmacovigilance signal detection, aggregate safety analysis, and post-market commitment analytics using spontaneous reporting databases, claims, and EHR data.
Digital Biomarker & Wearable Data Analytics
Analytics pipelines for continuous data streams from wearables and digital health platforms — extracting clinically meaningful endpoints and generating RWE from digital biomarkers.
Real-World Applications
A pharmaceutical company needs RWE to support a label expansion for an approved therapy in a new patient population.
Comparative effectiveness analysis using claims data, with propensity score matching and sensitivity analyses, produces a defensible evidence package submitted to FDA as part of the sNDA.
A biotech company needs a HEOR evidence package to support formulary inclusion negotiations with major payers.
Cost-effectiveness model and budget impact analysis developed using real-world cost and outcome data, with payer-specific customization for five major formulary submissions.
A digital health company needs to demonstrate real-world clinical validity of a wearable-based monitoring platform to health systems.
RWE analysis of digital biomarker data demonstrates concordance with clinical endpoints, supporting health system adoption and payer coverage submissions.
A health system needs population health analytics to identify high-cost patient cohorts and evaluate intervention effectiveness.
Claims and EHR-based population analytics identify highest-risk cohorts and quantify the clinical and economic impact of care management interventions.
Ready to Discuss Real-World Evidence & Patient Outcomes?
Our team will assess your program context and design a solution scoped to your data environment, regulatory obligations, and timelines.