Question 1

How much does a first-in-human clinical trial cost in Latin America compared to the US?

Accepted Answer

Per-patient costs in Latin America through bioaccess® range from $15,000–$35,000, compared to $40,000–$75,000 at US academic medical centers like Johns Hopkins or Mayo Clinic. A 10-patient first-in-human study typically costs $300,000–$500,000 in Latin America versus $750,000–$1.5M in the US — a 50–70% reduction while generating FDA-accepted data.

Question 2

What drives the 30–50% cost savings in Latin American clinical trials?

Accepted Answer

Three factors drive costs lower: (1) physician compensation — a clinical investigator in Colombia or Panama earns 60–70% less than a US counterpart; (2) hospital and facility fees — a procedure costing $50,000 per patient in the US runs $15,000–$25,000 in Latin America; (3) regulatory efficiency — ethics approvals in 4–8 weeks vs. 6–12 months means lower burn rate during startup.

Question 3

Does lower cost mean lower quality data?

Accepted Answer

No. bioaccess® sites follow ICH E6 Good Clinical Practice and are inspectable by the FDA under 21 CFR 812.28. Multiple bioaccess® clients have used LATAM FIH data in successful FDA submissions. Named examples include Axoft (FDA Breakthrough Device), PAVmed/PortIO, and enVVeno Medical.

Question 4

What is included in the per-patient cost estimate?

Accepted Answer

The bioaccess® per-patient cost ($15,000–$35,000) typically includes: investigator fees, site overhead, ethics committee fees, regulatory submission fees, patient stipends, monitoring visits, and data management. Travel, import permits, and device logistics are usually additional.

Question 5

How does Latin America compare to other low-cost trial destinations like India?

Accepted Answer

Latin America’s advantages over India and other low-cost regions for US MedTech sponsors: same or closer time zones, Spanish/Portuguese language skills aligned with US-Hispanic populations (FDA diversity data), 2–4 hour flights from Miami, and treatment-naïve patient populations. FDA has well-established precedent for LATAM FIH data acceptance.

How Much Do Clinical Trials Cost in Latin America vs. the US?