Comprehensive cost benchmarks for first-in-human and early feasibility studies across Latin America — with line-item breakdowns, country comparisons, and hidden cost analysis.
March 25, 2026
14
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
"How much will my clinical trial cost?" is the question every MedTech, Biopharma, and Radiopharma sponsor asks first — and the one that's hardest to answer without context. This benchmark analysis draws on bioaccess®'s 15+ years of budget data across 50+ client programs to provide the most accurate cost comparisons available between Latin America and the US/EU for first-in-human and early feasibility studies.
**The short answer**
In 2026, sample LATAM FIH budgets run Budget depends on study design; we provide a study-specific quote, based on bioaccess®'s 15+ years of budget data across 50+ client programs. Total study costs scale with that per-patient gap, but sponsors should still budget for hidden costs. Use the bioaccess® Clinical Trial Calculator for an estimate tailored to your device and study design.
**💡 Get a Personalized Estimate**
These benchmarks are industry averages. For a cost estimate tailored to your specific device, therapeutic area, and study design, use the bioaccess® Clinical Trial Calculator.
What drives per-patient costs?
Per-patient costs are the most commonly cited — and most misunderstood — metric in clinical trial budgeting. These figures include all direct patient-related costs: investigator fees, study coordinator fees, institutional fees, laboratory tests, imaging, patient stipends, and follow-up visits.
For budgeting: budget depends on study design; we provide a study-specific quote. Chile charges no regulator fee; Costa Rica adds a 3% CONIS levy, the only such levy in Latin America.
How do ethics approval timelines compare?
Timeline is often more valuable than cost savings. The ethics/IRB approval phase is typically the single largest bottleneck in study activation — and LATAM's advantage here is dramatic:
| Country / Region | Ethics Approval | Total Startup |
|---|---|---|
| El Salvador (DNM/CNEIS) | Varies by study; we confirm per protocol (parallel) | Varies by study; we confirm per protocol |
| Panama (MINSA) | Varies by study; we confirm per protocol | Varies by study; we confirm per protocol |
| Colombia (INVIMA) | Varies by study; we confirm per protocol | Varies by study; we confirm per protocol |
| Mexico (COFEPRIS) | Varies by study; we confirm per protocol | Varies by study; we confirm per protocol |
| Brazil (ANVISA/CONEP) | Varies by study; we confirm per protocol | Varies by study; we confirm per protocol |
| United States (IRB) | Varies by study; we confirm per protocol | Varies by study; we confirm per protocol |
| European Union (EC) | Varies by study; we confirm per protocol | 10–16 months |
What does a 10-patient FIH study cost in total?
Small first-in-human studies are the most common FIH design. Here is what our rate card gives for two sample studies:
**📊 Sample bioaccess® FIH budgets (illustrative, not a quote)**
Budget depends on study design; we provide a study-specific quote.
What does a 30-patient study cost in total?
For larger feasibility or pivotal-supporting studies, the total scales with subjects, sites and follow-up.
For budgeting: budget depends on study design; we provide a study-specific quote. Chile charges no regulator fee; Costa Rica adds a 3% CONIS levy, the only such levy in Latin America. Adding subjects, sites or follow-up raises the total; the clinical trial calculator shows how.
How do costs break down by category?
Understanding where your money goes helps you make informed decisions about study design and country selection.
Site fees
Site fees are the largest single cost category, typically representing 40-55% of total study costs. These include investigator compensation, study coordinator time, institutional overhead, pharmacy fees, laboratory services, and imaging.
Regulatory & ethics costs
Regulatory and ethics fees vary by country. Chile charges no regulator fee, while Costa Rica adds a 3% CONIS levy on the total study budget, the only such levy in Latin America.
Monitoring & CRA costs
bioaccess® uses ACRP-certified CRAs who monitor to the same ICH-GCP standards as US monitors.
Data management & biostatistics
bioaccess® uses FDA-compliant electronic data capture systems (including Greenlight Guru Clinical) and employs biostatisticians experienced in FDA submission-ready clinical study reports.
What hidden costs should sponsors watch for?
Transparency is essential. Here are LATAM-specific costs that some CROs fail to disclose upfront:
- Device import and customs clearance: $5K-$15K depending on device classification and country. Requires import permits from INVIMA, COFEPRIS, or the relevant regulatory agency.
- Clinical trial insurance: $8K-$25K per study. Most LATAM countries require sponsor-funded clinical trial insurance covering patient injuries. Costs vary by country and number of patients.
- Certified translations: $3K-$8K for protocol, informed consent, investigator brochure, and regulatory documents. All submissions must be in Spanish (or Portuguese for Brazil).
- International travel: $2K-$5K per monitoring trip for sponsors who want to observe procedures or conduct site visits. Budget 3-4 trips for a 10-patient study.
- Currency fluctuation risk: Minimal for dollarized economies (El Salvador, Panama) but relevant for Colombia (COP), Brazil (BRL), and Mexico (MXN). bioaccess® mitigates this through fixed-price contracts in USD.
- Re-export of unused devices: $2K-$5K if devices must be returned to the sponsor after study completion rather than destroyed locally.
**⚠️ Red Flag: CROs That Don't Disclose These Costs**
If a CRO's budget proposal doesn't include line items for insurance, device import, and translations, ask specifically. These are real costs that will appear eventually — it's better to know them upfront than to face budget overruns mid-study.
How do you get a personalized estimate?
These benchmarks provide directional guidance, but every study is unique. The bioaccess® Clinical Trial Calculator generates a personalized cost estimate based on your specific device type, therapeutic area, number of patients, and country preferences.