Why run clinical trials in Latin America

01 / The bottleneck

Enrollment, not science, is what delays trials

Roughly 80% of clinical trials fail to meet their enrollment timelines, and up to half of research sites enroll one patient or none at all. With a delayed launch costing as much as $8M in lost revenue per day, where you place a study has stopped being a cost decision and become a timeline decision.

02 / Patient access

The patients are there, and under-enrolled

Latin America holds more than 8% of the world's population but hosted only about 3.6–5% of global oncology trials in 2023. That gap is the opportunity: 650M+ people, over 80% of them urban, with treatment-naïve populations and far less competition per site than North America or Western Europe.

It is also one of the most ancestrally admixed populations on the planet — Indigenous, European and African lineages within the same trial population. For sponsors who need enrollment that reflects real-world patient diversity, that representativeness is structural here rather than something you have to engineer site by site.

03 / Seasonal advantage

Two hemispheres, one shorter calendar

For influenza, RSV and other seasonal indications, the Southern Hemisphere winter runs roughly six months offset from the Northern one. Sponsors can run a parallel cohort here while their U.S. and European sites wait for the season to arrive, opening two enrollment windows in the same year instead of waiting a full cycle for the second.

04 / Cost & proximity

Lower cost, same time zone

Sponsors in Brazil and Argentina typically pay 20–30% of equivalent U.S. costs, cheaper per site than Western Europe, Oceania or Asia-Pacific. Unlike those regions, Latin America shares U.S. time zones, so the savings don't cost you real-time collaboration. And this is not a shrinking market: regional clinical trial spend is projected to grow from about $1.5B in 2025 to $2.8B by 2033, an 8.2% CAGR, with Argentina expected to post the fastest growth in the region.

05 / Medical devices

MedTech is where the region is professionalizing fastest

Device research is the niche most CROs in the region treat as a side line, and it is the one growing into serious work. Latin America accounted for 2.1% of the global medical device clinical trials market in 2024 — about $357M, heading to $457M by 2030 — and within that, pivotal studies are both the largest segment at 42.4% and the fastest growing, with Brazil leading regional growth. Pivotal device work is exactly the kind that has to survive an FDA inspection.

06 / Regulatory momentum

The rules are getting faster, not slower

Brazil's Law 14.874/2024, in force since August 2024 and regulated by Decree 12.651/2025, gives the regulator 90 business days to respond to a trial application and lets studies start on local ethics committee review alone, removing a layer that used to define Brazilian start-up. Every country in the region operates under ICH-GCP with active inspection systems, and sponsors already trust LatAm with pivotal work: the region carries roughly 15.6% of global Phase III oncology trials, even while early-phase activity stays thin.

07 / Country by country

Six different start-up clocks, and where we sit on them

"Latin America" is not a single regulatory environment. Median time from submission to first patient ranges from under three months to nine, and that spread is the most important variable in a regional feasibility decision.

08 / Where friction shows up

Where it gets hard, and how we clear it

A study placed in Peru or Colombia can wait two to three times longer to activate than the same study in Mexico. Regulatory timelines and customs are where trials lose time in this region, and neither is solved remotely. LatinaBA runs in-country regulatory experts who get submissions right the first time and dedicated customs brokers who handle import/export country by country, so the friction is absorbed before it reaches your timeline.