This is a pre-CRO checklist — the questions I'd walk through with a VP of Clinical at an emerging biotech before their team writes a CRO RFP that includes Brazil. None of them require data you don't already have. All of them surface the risks most often ignored in kickoff decks and surfaced six months later in first-patient-in slippage.
Does your protocol match a therapeutic area with active recruitment infrastructure in Brazil?
The Q2 2026 Brazilian industry-trial market is 582 trials distributed very unevenly: oncology 250, cardiovascular 35, neurology 29, rheumatology 26, rare disease 25, nephrology 24, metabolic 21, pulmonology 20, gastroenterology 15, infectious disease 11, dermatology 11, psychiatry 9, ophthalmology 3, women's health 1. If your TA is oncology, metabolic, neurology, IBD, derm, or rare disease, infrastructure exists and is active. If your TA is ophthalmology (3) or women's health (1), you will be among the first — which is doable but a different problem.
Grounded in: Samba Trials Q2 2026 data.
Do your comparator drugs have local market availability — and crucially, SUS access?
Brazilian ethics committees (CEP and CONEP) will look closely at what happens to trial participants after the trial ends and whether your active comparator reflects Brazilian standard of care. If your comparator is licensed in Brazil but not reimbursed through SUS, reviewers will ask whether non-responders can access it post-study. If your comparator is not licensed in Brazil, ANVISA will want to know why it's the right comparator for the Brazilian arm. Address this in the protocol, not in a CONEP response letter.
Common miss: GLP-1, GLP-1/GIP, and modern MS/IBD biologics where SUS access lags global availability.
Are your inclusion/exclusion lab thresholds compatible with local reference ranges?
Brazilian clinical labs largely use reference ranges aligned with CLSI and international norms, but small differences exist — especially in hematology (hemoglobin threshold for anemia inclusion), thyroid panels, and some inflammatory markers. Have your medical team cross-check your I/E lab criteria against the reference ranges published by the labs you'll actually use (Fleury and Dasa are the two largest networks). A 0.2 g/dL hemoglobin shift or a 5-unit CRP cutoff difference can materially change your screen-fail rate.
Quick sanity check: pull a sample of 30 of your target-population patients' labs from one Brazilian academic center and simulate your I/E. If screen-fail is >40%, re-tune.
Which Brazilian states and cities match your target-population demographics?
Brazil is not demographically uniform. Rio Grande do Sul (189 trials) has a substantial Germanic and Italian-descent population — relevant for some pharmacogenetic profiles and population-genetics substudies. Bahia (78 trials) and Pernambuco (34) have larger Afro-Brazilian populations — relevant for sickle-cell, some hypertension programs, and representativeness arguments. São Paulo metro is broadly diverse. Rio Grande do Norte and Bahia feature in some consanguinity-prevalence rare-disease recruitment stories. Don't over-claim — but do match state selection to population-relevance.
Honest framing: we can help you stress-test this against your protocol. Not every program needs demographic granularity; some do.
How will the ANVISA timeline interact with your IND strategy?
Under Lei 14.874/2024 the Brazilian CT authorization target is ~6 months; we're seeing well-run submissions activate inside 6-8 months. If you are filing IND in the U.S. in Q3 and want Brazilian arms live at first-patient-in globally, you need to be filing to ANVISA and CONEP in parallel with your IND, not after FDA acceptance. The alternative — IND first, then Brazilian submission — adds 6-8 months of lag to Brazilian activation. See our ANVISA timeline piece for the operational detail.
Rule of thumb: start Brazilian regulatory work 3-4 months before your global protocol lock, not 3-4 months after.
Does your protocol include biospecimen export, and is the Termo de Transferência written?
Almost every modern protocol exports samples — genomic DNA, serum biomarkers, tissue, microbiome. Under CONEP rules (Resolução CNS 441/2011, 446/2011), a formal Termo de Transferência de Material Biológico is required for any biospecimen export from Brazil, and it must be in your original CONEP dossier, not added later. Retrofitting this as an amendment can add 60-90 days to activation. Draft the TTMB language before dossier filing.
Common miss: biomarker substudies added after protocol lock with no TTMB strategy. Avoidable.
Which sites will you activate first — and what are their competing-trial loads?
Brazil's top research centers run 15-53 active industry trials simultaneously. HCPA runs 53. Barretos runs 18. Sírio-Libanês runs 12. Each PI has a working caseload. If your CRO lists HCPA for your IBD Phase 2b and HCPA is already running three advanced-mechanism IBD protocols, your screen-fail rate will spike and enrollment will slow. Before site selection, check the competing-trial overlap at your target centers. This is protocol-specific consultancy work; generic site lists don't surface it.
Our feasibility memos produce this overlap map as a standard deliverable.
Does your protocol design match what Brazilian CEP and CONEP will accept on informed consent?
Brazilian Portuguese ICF adaptation is not translation. CNS Resolução 466/2012 sets expectations for reading level (8th-grade or lower), mandatory sections (risks, benefits, post-trial access, data privacy, contact info), and participant-rights language. Literal translations from English frequently trigger CEP rejection rounds that add weeks. Budget for proper adaptation by an experienced local regulatory team — don't ship what your global vendor drafted.
Quick signal: if your ICF is over 40 pages, it's almost certainly rejectable on clarity grounds. Simplify.
Does your post-trial access plan meet Brazilian expectations?
Lei 14.874/2024 formalized post-trial access obligations for sponsors where the investigational therapy shows benefit for the participant. "We'll decide case-by-case" isn't sufficient. The protocol and ICF should describe either (a) continued trial-drug supply for responders until commercial availability, (b) open-label extension enrollment, or (c) participant-access arrangements through the sponsor's regional team. Have this plan written before CONEP submission.
This is often the single cheapest thing to add to your protocol and the single most common CONEP sticking point.
Who on your team actually owns the Brazilian arm?
The operational pattern we see most often fail: global program manager owns "Brazil" as a bullet on the Gantt chart; regional CRO liaison handles day-to-day; no single person at the sponsor has authority to adjudicate Brazilian-specific choices (comparator access, biospecimen export strategy, site mix). The result is slow decisions on issues that have 30-day CONEP response clocks. Name a sponsor-side Brazilian lead before protocol lock, even if the time commitment is 5% FTE. Authority matters more than hours.
If you don't have that person internally, external consultancy (ours or another) can proxy — but they need real authority, not advisory-only status.
How to use this checklist
Walk through these 10 questions with your clinical leadership team in one sitting, before CRO selection. If you can answer 8+ confidently with specifics (not just "we'll figure it out"), you're well-positioned. If you can answer fewer than 6, you probably need a feasibility memo or Brazilian regulatory consultancy before your CRO RFP. That's not a sales pitch — it's a risk-management pattern. Walking into a Brazilian engagement with five unknowns is how programs slip 6-9 months.
Want a protocol-specific version of this checklist?
Send us your protocol synopsis. We'll return a Brazil-specific feasibility memo in two weeks — with these 10 questions answered against your actual indication, comparator, and timeline.
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