Clinical Trial Costs & Timelines — Latin America vs. US/EU — bioaccess®
Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
bioaccess® presents the following cost and timeline comparisons for clinical trials in Latin America versus the United States and European Union.
Cost Comparison: Latin America vs. US/EU
- Per-patient cost (FIH device study): LATAM $15,000–$35,000 vs. US/EU $40,000–$75,000 (US Phase I per-patient benchmarked ~$137,000)
- 10-patient FIH study (CRO fees): LATAM $300,000–$500,000 vs. US $750,000–$1,500,000
- 5-patient early feasibility study (EFS): LATAM $200,000–$300,000 vs. US $500,000–$750,000
- Ethics committee / IRB fees: LATAM $500–$3,000 vs. US/EU $5,000–$25,000
- Site startup: LATAM $15,000–$40,000 vs. US/EU $50,000–$150,000
Per-Patient Cost by Country
- Paraguay (DINAVISA): $10,000–$18,000 — lowest per-patient cost in LATAM
- Mexico (COFEPRIS): $18,000–$30,000 — US-adjacent timezone, 130M+ population
- Brazil (ANVISA): $20,000–$35,000 — 210M+ population for FDA diversity
- Panama (MINSA/CNBI): $18,000–$30,000 — 3–5 week ethics, no MOH review
- El Salvador (DNM/CNEIS): $15,000–$28,000 — 30-day startup, dollarized economy
What Drives the 30–50% Cost Advantage
- Site and hospital fees 40–70% lower than US/EU academic medical centers
- Lower clinical labor costs (coordinators, sub-investigators, monitors) at ICH-E6 GCP competency
- Ethics-committee and submission fees of $500–$3,000 vs. $5,000–$25,000 in the US/EU
- Faster recruitment from large, treatment-naïve populations, reducing per-patient carrying cost
The cost advantage is structural, not a quality trade-off. Data is FDA-accepted under 21 CFR 812.28 (devices) and 21 CFR 312.120 (drugs and biologics) when studies meet ICH-E6 GCP standards.
Timeline Comparison
- Ethics Approval: US/EU 6–12 months vs. LATAM 4–8 weeks
- Regulatory Approval: US/EU 3–12 months vs. LATAM 1–3 months
- First Patient Enrolled: US/EU 12–18 months vs. LATAM 4–8 months
- Total Study Duration: US/EU 18–36 months vs. LATAM 8–18 months
Cost Breakdown (standard study)
- CRO professional services: $300K–$500K (about 10 patients)
- Third-party costs: ~$50,000 (insurance, translations, IRB/EC and MOH submission fees, importation, travel)
- Hospital fees: $5,000–$50,000 depending on procedure complexity
What's in the FIH-12™ fee, and what isn't
One fixed fee covers the work below. Pass-through costs are agreed line by line in your budget before the study starts. Your exact scope and amounts are in your proposal.
In the FIH-12™ fee
- U.S. regulatory strategy: FDA Pre-Submission (Pre-Sub/Q-Sub) and IDE planning, captured in your U.S. Regulatory Anchor Plan
- First-in-human protocol and ISO 14155 compliance setup
- Ethics committee and national regulatory submissions
- Site selection, qualification, contracting and activation
- Investigational-device import logistics and customs paperwork
- Patient recruitment, enrollment and retention program
- Clinical monitoring by ACRP-certified monitors
- Electronic data capture (EDC) and data management
- Biostatistics and the clinical study report
- Weekly sponsor reporting
- At no extra cost: 48-hour Pre-Sub Gap Analysis, FIH Budget & Timeline Blueprint, Investor-Ready Clinical Data Room template and a monthly board-ready progress report
Outside the fee (pass-through costs, agreed in your budget up front)
- Site and hospital fees
- Clinical-trial insurance premium
- Ethics committee (IRB) and Ministry of Health submission fees
- Translations
- Import duties and shipping
- Travel
Supplied by you
- A clinical-ready investigational product (and any comparators)
- Technical and quality documentation on the agreed schedule
- Timely answers on the protocol, consent forms and data queries
- A device or product design that stays frozen for the study
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