Brazil has more than 210 million people, one of the most diverse populations in the world, and a healthcare system that generates longitudinal clinical data at scale. What was missing was the infrastructure to turn that potential into high-standard regulatory evidence.
iHealth is the only Brazilian RWE consultancy with integrated proprietary clinical data — electronic health records, lab tests, and pharmacy records — from more than 40 selected hospitals across 5 regions of Brazil. Structured through NLP for medical Portuguese and clinically validated. For CONITEC, ANVISA, and global submissions.
Global phase III trials exclude Brazil due to a lack of structured, accessible clinical data. CONITEC dossiers are built with international data because no local database meets regulatory quality standards. Market access strategies are built on projections — not real data from Brazilian patients.
iHealth closes that gap. We have the clinical database, the RWE methodology, and the hospital partners to support every stage of your project — from study design to regulatory submission.
Generating regulatory-grade evidence from real-world longitudinal data. We design and execute comparative effectiveness studies, disease burden analyses, patient journey mapping, safety analyses, and external control arms — using real clinical data from Brazilian patients, structured through NLP and clinically validated. For CONITEC, ANVISA, and global submissions (FDA, EMA, NICE, and other HTAs).
Pharmacoeconomic analyses, cost-effectiveness models, and value dossiers for technology incorporation with Brazilian and LATAM HTAs. We build value arguments with real data — not theoretical projections. Product positioning, budget impact analysis, and pricing strategy grounded in the real epidemiology of the Brazilian population.
Building external control arms from our longitudinal clinical database — for single-arm clinical trials, rare disease studies, and situations where a classic RCT is unfeasible or ethically questionable. Data selected, matched, and documented with full regulatory traceability.
Smart identification of eligible patients in hospital databases of +5 million lives — by diagnosis, treatment line, comorbidities, biomarkers, and NLP-extracted clinical variables. Protocol feasibility analysis, site mapping by epidemiological fit, and digital study monitoring. Faster recruitment, lower operational cost.
Precise identification of clinical profiles across databases of +5 million lives — for research, commercial intelligence, and access. Segmentation by primary and secondary diagnosis, current treatment line, specific medication use, comorbidities, biomarkers, and NLP-extracted clinical variables. Clinically validated results, documented for use in regulatory studies.
Characterization of the Brazilian patient population by therapeutic indication: prevalence, incidence, demographic profile, current treatment patterns, clinical outcomes, and cost of disease — all with real clinical data, not estimates. Support for launch planning, pricing, and market access strategy.
iHealth owns its data infrastructure. We don't broker data from other sources — we generate, structure, and maintain our own longitudinal clinical database, with full control over quality, traceability, and regulatory compliance.
Our NLP engine isn't a generic tool adapted for Portuguese. It was built from the ground up for the vocabulary, abbreviations, and narrative structures of Brazilian medical Portuguese — with clinical precision validated by specialists.
40+ hospitals across all 5 regions of Brazil — not just São Paulo and Rio. That means real epidemiological representativeness of the Brazilian population, with geographic, demographic, and treatment-pattern diversity.
Our studies are designed with methodological rigor aligned with CONITEC, ANVISA, FDA, and EMA standards. Full traceability, documented legal bases, versioned protocols, and outputs ready for regulatory submission.
We have the database. We have the methodology. And we have the hospital partners to support your project — from RWE and Market Access to clinical research and regulatory dossiers.
