Elevating Evidence
Through AI
Transforming Real-World Data into Actionable Insights for Life Sciences.
- 300M+
- Patient lives
- 40+
- Pharma partners
- 98%
- Study on-time
Built for leading life sciences organizations
Platform
A unified evidence platform for modern life sciences
From study design to payer submission, Elevora brings AI, data, and clinical expertise into a single workflow.
Real-World Data at Scale
Full coverage of US claims and EMR data — IQVIA, Optum, Komodo, Truveta, HealthVerity, Datavant, Flatiron, TriNetX, PCORnet, Medicare/Medicaid, and more — across 300M+ patient lives.
AI-Augmented Analytics
AI-assisted literature search and summarization, cohort discovery, predictive modeling, outcomes research, natural language processing of clinical notes, and automated evidence synthesis.
HEOR & Market Access
HCRU, cost-of-illness, comparative effectiveness, budget impact, cost-effectiveness, burden-of-illness, and payer-ready evidence packages — accelerated.
Regulatory Grade
Aligned with FDA RWE guidance — external control arms, fit-for-use RWD assessment, study design and data standards — plus 21 CFR Part 11, HIPAA, GDPR, and SOC 2 Type II. Audit-ready by design.
Why Elevora
Evidence built for the questions that matter
We pair PhD-level scientific rigor with proprietary AI to deliver evidence that holds up to scientific, regulatory, and payer scrutiny — at the speed your portfolio demands.
- Federated access to 300M+ patient lives globally
- AI cohort builder validated across 12 therapy areas
- Pre-built study templates accepted by FDA and EMA
- Dedicated scientific lead on every engagement
Therapeutic depth
Built across the conditions shaping medicine
Service depth
Built for US FDA and US payer evidence needs
Purpose-built RWE, HEOR, and regulatory services aligned with FDA's Real-World Evidence Program and the evidence standards of CMS, ICER, AMCP, and US commercial payers.
Submission-ready RWE for FDA decision-making
External Control Arms & Hybrid Trials
Fit-for-use RWD assessment, propensity-score matched comparators, and synthetic control arms aligned with FDA's RWE Framework and 2023–2024 final guidances.
Natural History & Disease Registries
Prospective and retrospective natural history studies supporting rare disease, accelerated approval, and post-marketing commitments.
Post-Marketing Safety & PASS/PAES
FDA-mandated post-approval safety studies, REMS assessments, and Sentinel-aligned active surveillance using claims and EHR data.
Regulatory Strategy & Submissions
Type B/C meeting packages, RWE study protocols, data quality and relevance memos, and 21 CFR Part 11 compliant study conduct.
Evidence that moves US payers and PBMs
Cost-Effectiveness & Budget Impact
US-payer perspective CEA, BIM, and cost-of-illness models built to AMCP Format 4.1 and ICER methodological standards.
AMCP Dossiers & Value Communication
Pre-approval information exchange (PIE) decks, AMCP-format value dossiers, and objective value frameworks for commercial and Medicare payers.
HCRU, Real-World Outcomes & CER
Healthcare resource utilization, total cost of care, treatment patterns, and comparative effectiveness across Medicare, Medicaid, and commercial claims.
IDN, PBM & Medicare/Medicaid Access
Formulary positioning, IRA and Medicare Part D negotiation analytics, 340B and Medicaid best price scenarios, and IDN evidence packages.
Methodology briefs & POVs
Where US policy meets evidence strategy
Short, opinionated briefs from our scientific team on FDA RWE guidance, the Inflation Reduction Act, and ICER value assessments — written for evidence, HEOR, and market access leaders.
Operationalizing FDA's External Control Arm Guidance
A practical POV on the 2023 draft guidance — fit-for-use data, propensity scoring, missingness, and pre-specification choices that hold up at advisory committee.
Real-World Data: Assessing Relevance and Reliability
How to build the data quality memo FDA expects under 21st Century Cures, with templates for EHR, claims, and registry sources.
Medicare Drug Price Negotiation: Evidence That Moves CMS
What manufacturers should be generating now for Selected Drug List candidates — therapeutic alternatives, unmet need, and equity evidence under IRA Sections 1191–1198.
Part D Redesign & Launch Strategy Under the IRA
Modeling the 2025 Part D out-of-pocket cap, manufacturer discount program, and small-biotech exception in budget impact and launch forecasts.
Designing CEAs That Survive ICER Review
Reference case alignment, modified societal perspective, equal-value life-years gained (evLYG), and the most common ICER critiques — and how to pre-empt them.
ICER Evidence Reports: Engaging Before the Draft
A playbook for scoping, evidence submission, and policy roundtable engagement to shape ICER assessments before they shape payer policy.
Publications
Peer-reviewed research & conference presentations
Selected work from our scientific team across HEOR, RWE, and AI-driven analytics.
- ViewStatistics in MedicinePeer-Reviewed Article2026
Time-Varying Treatment Effect Models in Stepped-Wedge Cluster-Randomized Trials With Multiple Interventions
Chen Z, Wang W, Lu Y, Halpern SD, Courtright KR, Li F, Harhay MO.
- ViewStatistics in MedicinePeer-Reviewed Article2024
A mixed model approach to estimate the survivor average causal effect in cluster-randomized trials
Wang W, Tong G, Hirani SP, Newman SP, Halpern SD, Small DS, Li F, Harhay MO.
- ViewAm. J. Respir. Crit. Care Med.Peer-Reviewed Article2022
Association of ICU Admission and Outcomes in Sepsis and Acute Respiratory Failure
Anesi GL, Liu VX, Chowdhury M, Small DS, Wang W, et al.
- ViewTrialsPeer-Reviewed Article2021
A comparative study of R functions for clustered data analysis
Wang W, Harhay MO.
- ViewAnnals of Internal MedicinePeer-Reviewed Article2014
Racial disparities in colon cancer survival: a matched cohort study
Silber JH, Rosenbaum PR, Ross RN, Niknam BA, Ludwig JM, Wang W, et al.
- ViewMedical CarePeer-Reviewed Article2023
Prediction of In-hospital Mortality Among Intensive Care Unit Patients Using Modified Daily Laboratory-based Acute Physiology Score, Version 2
Kohn R, Weissman GE, Wang W, et al.
- ViewStatistical Methods in Medical ResearchPeer-Reviewed Article2019
A review and empirical comparison of causal inference methods for clustered observational data with application to the evaluation of the effectiveness of medical devices
Cafri G, Wang W, Chan PH, Austin PC.
- ViewHealth Services ResearchPeer-Reviewed Article2016
Improving Medicare's Hospital Compare Mortality Model
Silber JH, Satopää VA, Mukherjee N, Rockova V, Wang W, et al.
Open Data
Public US healthcare datasets we work with
Authoritative, publicly available data from CDC, CMS, AHRQ, NIH, and FDA — ready to complement proprietary RWD for surveillance, burden-of-illness, and policy research.
NHANES
CDC
National Health and Nutrition Examination Survey — health, nutrition, and lab data on the US population.
NHIS
CDC / NCHS
National Health Interview Survey — annual household health status, access to care, and behavior data.
BRFSS
CDC
Behavioral Risk Factor Surveillance System — state-level chronic disease, risk behavior, and preventive service data.
WONDER
CDC
Mortality, natality, cancer, STD, TB, and environmental data with online query tools.
Medicare Public Use Files
CMS
Provider utilization, payment, Part D prescriber, and chronic conditions data for Medicare beneficiaries.
MEPS
AHRQ
Medical Expenditure Panel Survey — health services use, cost, insurance, and access for US households.
HCUP
AHRQ
Healthcare Cost and Utilization Project — inpatient, ED, and ambulatory surgery encounter databases (NIS, NEDS, KID).
SEER
NCI
Surveillance, Epidemiology, and End Results — population-based cancer incidence and survival data.
All of Us Research Hub
NIH
EHR, surveys, wearables, and genomic data from 1M+ diverse US participants (registered/controlled tiers).
FDA openFDA
FDA
APIs for adverse events (FAERS), drug labeling, recalls, device events, and food enforcement reports.
ClinicalTrials.gov
NIH / NLM
Registry and results database of publicly and privately supported clinical studies worldwide.
HealthData.gov
HHS
Federated catalog of 3,000+ federal, state, and local health datasets across HHS agencies.
Industry Pulse
Top pharma news, updated daily
FDA approvals, CDC alerts, and WHO global health updates — sourced directly from official feeds.
AI × Real-World Evidence
AI in real-world evidence, today
The latest on how artificial intelligence is transforming RWE generation, RWD analytics, and evidence-based decision-making across healthcare.
Ready to elevate your evidence strategy?
Talk to our scientific team about your next study, submission, or launch.