Why more sponsors are choosing Latin America for first-in-human studies, early feasibility trials, and pivotal clinical programs.
March 24, 2026
14
min read
By
bioaccess® Team
clinical trial site Latin America
clinical trials Latin America advantages
first-in-human trials Latin America
clinical trial costs Latin America
**The short answer**
Latin America offers clinical trial sponsors scope-based budgets, ethics and regulatory approvals in as little as Varies by study; we confirm per protocol, and enrollment that consistently hits 104% of target in published research. With diverse, treatment-naïve populations and bioaccess®'s Innovation Runway™ compressing timelines by up to 40%, the region is purpose-built for first-in-human and early feasibility programs. See how LATAM trial costs compare to US/EU benchmarks and why El Salvador is emerging as an FIH destination.
**Key takeaways**
- • Up to lower per-patient costs compared to US and EU trial sites
- • Ethics approvals on a timeline that varies by study (we confirm it per protocol) vs. months with traditional pathways
- • 104% enrollment target achievement — LATAM has exceeded recruitment forecasts in published research
- • Diverse, treatment-naive populations that enhance data quality and FDA regulatory acceptance
- • bioaccess® Innovation Runway™ compresses timelines by up to 40%
**Who is this for?**
This guide is for VP of Clinical Operations, Regulatory Affairs leaders, CMOs, and medical device/biopharma founders evaluating Latin America as a destination for first-in-human studies, early feasibility trials, or pivotal clinical programs.
For medical device, biopharma, and radiopharmaceutical companies seeking to advance clinical programs, Latin America has emerged as one of the most compelling regions in the world. The combination of lower costs, faster regulatory timelines, diverse patient populations, and experienced clinical infrastructure makes Latin America an ideal choice for first-in-human trials, early feasibility studies, and pivotal clinical programs. Here are ten key advantages of choosing a clinical trial site in Latin America.
1. How does Latin America accelerate trial timelines?
One of the most significant advantages of conducting clinical trials in Latin America is speed. Traditional CROs operating in the US and EU often face regulatory timelines that vary by study (we confirm per protocol) before a study can begin enrolling patients. In Latin America, bioaccess® achieves ethics committee and regulatory approvals on a timeline that varies by study (we confirm it per protocol) across countries like Colombia, Panama, and El Salvador. In Chile, ethics committee approval is a study-specific timeline (we confirm it per protocol).
bioaccess®'s proprietary Innovation Runway™ program compresses traditional 18-24 month clinical development timelines by up to 40%, enabling sponsors to move from protocol finalization to first patient enrolled in a fraction of the time required in traditional markets. For startups with limited runway, this acceleration can be the difference between reaching a critical milestone and running out of capital.
2. What drives clinical trial costs in Latin America?
Clinical trial costs in the United States and Europe continue to escalate, with Phase III trials costing an average of $55,716 per day in direct expenses alone. Latin America offers a compelling alternative: per-patient cost depends on study scope, operational expenses, exchange rates, and site costs.
Several countries also offer government incentives that further reduce the financial burden. Colombia, for example, provides a 50% R&D tax credit for clinical research activities conducted within the country. These structural cost advantages, combined with bioaccess®'s pre-negotiated site agreements that lower per-patient site costs, make Latin America a financially strategic choice for sponsors at every stage of development.
| Cost factor | US / EU | Latin America (via bioaccess®) |
|---|---|---|
| Per-patient cost | Baseline | Depends on study scope |
| Ethics/regulatory approval timeline | Varies by study; we confirm per protocol | Varies by study; we confirm per protocol |
| Site costs | High | Significantly lower |
| R&D tax incentives | Limited | Up to 50% (Colombia) |
| Pre-negotiated site savings | Rare | Lower per-patient site costs |
3. What makes LATAM patient populations an advantage?
Latin America is home to over 650 million people across more than 30 countries, representing extraordinary ethnic, genetic, and socioeconomic diversity. For clinical trial sponsors, this diversity translates directly into stronger, more generalizable data that is increasingly valued by the FDA and other global regulatory agencies.
Treatment-naive populations — patients who have not been previously exposed to the investigational therapy or similar treatments — are significantly more prevalent in Latin America than in the US or EU. This is particularly important for first-in-human studies, where baseline data integrity is critical. FDA also asks whether trial data apply to the US intended-use population, and FDORA (2022) requires Diversity Action Plans for Phase 3 drug studies and for device studies under an IDE or supporting a 510(k), De Novo or PMA — but only for studies that begin enrollment 180 days after FDA finalizes its guidance, which as of October 2026 is still a draft. Representative LATAM enrollment helps, provided sponsors show how it maps to the US population.
4. How do LATAM regulatory environments compare?
Latin American regulatory agencies have modernized significantly over the past decade, creating faster and more predictable pathways for clinical trial approval. Key regulatory timelines include:
- Colombia (INVIMA): study-specific approval timelines for clinical studies
- Brazil (ANVISA): Approximately 60-day review cycles for most device and drug studies
- Mexico (COFEPRIS): Established regulatory framework with large patient pools
- Panama (MINSA): Emerging fast-track pathway for first-in-human studies
- El Salvador (SRS): Rapidly developing FIH-friendly regulatory environment
- Chile (ISP): Strong regulatory framework with international recognition
bioaccess® navigates COFEPRIS, INVIMA, ANVISA, ANMAT, and other regional agencies on behalf of sponsors, managing the complete regulatory submission process from pre-submission meetings through final approval. This end-to-end approach eliminates the need for sponsors to build internal regulatory expertise for each country.
5. What local expertise do LATAM trial sites offer?
Successful clinical trials in Latin America depend on deep local knowledge — understanding not just the regulatory landscape, but the clinical culture, institutional dynamics, and operational realities of each country. bioaccess® has established partnerships with experienced local researchers, principal investigators, and healthcare professionals across the region.
These partnerships boost patient recruitment by up to 30% compared to sponsors who attempt to enter LATAM markets without local support. Local investigators bring established relationships with patient communities, institutional review boards, and hospital administration — all of which accelerate study start-up and ensure ethical, high-quality execution.
6. Why is patient recruitment faster in Latin America?
Patient recruitment is the single largest bottleneck in clinical trial execution worldwide. Over 80% of clinical trials in the US fail to meet enrollment deadlines, with delays costing sponsors up to $8 million per day in unrealized revenue. Latin America has exceeded global enrollment targets — achieving 104% of predicted enrollment according to published research.
Highly urbanized populations concentrated in major metropolitan areas, combined with strong physician-patient relationships and bioaccess®'s Global Trial Accelerators outreach program, create the conditions for rapid and reliable enrollment. For sponsors running multi-site studies, this recruitment reliability significantly de-risks the clinical timeline.
7. How does cultural alignment improve trial conduct?
Patient retention is just as important as recruitment — and cultural alignment plays a critical role. Latin American clinical trial sites, when supported by culturally competent CROs, achieve patient retention rates of up to 89%, well above global averages.
bioaccess® employs culturally sensitive approaches to patient communication, including informed consent processes adapted to local languages and literacy levels, personalized follow-up protocols, and community engagement strategies. This approach builds trust with participants and their families, reducing dropout rates and ensuring data integrity throughout the study.
8. What trial designs work best in Latin America?
Latin America's regulatory flexibility enables the implementation of innovative trial designs that may be more difficult to execute in the US or EU. Decentralized clinical trials (DCTs), adaptive trial designs, and hybrid monitoring models are all feasible across multiple LATAM countries.
Regulatory approval timing in Panama and El Salvador varies by study; we confirm it per protocol. In Chile, ethics committee timing also varies by study. bioaccess®'s pre-negotiated site agreements deliver lower per-patient site costs, while the flexible regulatory environment allows for protocol amendments and adaptive modifications that would require months of additional review in traditional markets.
9. Why partner with local institutions?
Partnerships with leading academic medical centers and hospital systems across Latin America provide sponsors with access to world-class clinical infrastructure, experienced research teams, and established patient referral networks. These institutional collaborations lend credibility to clinical data and can facilitate regulatory acceptance by both regional and international agencies.
bioaccess® has established relationships with top-tier institutions across Colombia, Mexico, Brazil, Panama, El Salvador, Chile, and other LATAM countries. These partnerships provide access to specialized clinical capabilities — from interventional radiology suites for TACE procedures to advanced imaging centers for radiopharmaceutical studies — that are essential for complex first-in-human trials.
10. How does LATAM support global market access?
Latin America's geographic proximity to the United States and time zone alignment with North American sponsors streamlines communication, logistics, and operational oversight. Clinical supplies, biological samples, and regulatory documents can be transported efficiently between LATAM sites and US-based sponsors.
Additionally, clinical data generated in Latin America under bioaccess® supervision is produced in full compliance with ICH-GCP guidelines and FDA requirements, making it directly applicable to US and EU regulatory submissions. This positions LATAM trial data as a strategic asset for global market access and commercialization planning.
How can bioaccess® help?
As a CRO purpose-built exclusively for first-in-human clinical trials, bioaccess® accelerates the path from prototype to human data across Latin America. From regulatory strategy and ethics committee submissions to site selection, patient recruitment, and clinical monitoring, bioaccess® provides end-to-end support designed for MedTech, biopharma, and radiopharmaceutical startups.
Whether you are planning your first clinical study or expanding an existing program into Latin America, bioaccess® can help you move faster, spend less, and generate the data you need for FDA submission and global commercialization.
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Related resources:
- First-in-human CRO services — /first-in-human-cro
- Market access services — /market-access
- Compare bioaccess® vs. other CROs — /compare
- Case studies and results — /case-studies