Ophthalmology CRO · Latin America
A full-service CRO dedicated to ophthalmology, with deep specialization in retina. We connect sponsors with the region's leading investigators and reference sites to develop sight-saving therapies.
FAROS is a Latin American CRO, run from Latin America, for the whole of Latin America. Founded by retina leaders in the region, we operate a network of more than 50 specialized ophthalmology sites across Argentina, Brazil, Mexico, Colombia and beyond — sites with, on average, more than 20 years of clinical research experience.
We are a CRO based in Buenos Aires, Argentina who serves regionally through partnership by professionals who live and work there. They speak the language, they know the regulator, and they have activated sites in that country before.
More than 50 specialized sites across Latin America, coordinated under one operational structure and one point of accountability for the sponsor.
Ophthalmology only. Most of our strategic partner sites are led by internationally renowned retina specialists, involved from protocol design onwards.
Direct working knowledge of ANMAT, ANVISA, INVIMA and COFEPRIS — the difference between a published timeline and an activated site.
Capabilities
Quality, integrity and responsiveness for every development program, large or small. Select any service to see how we deliver it.
The regional case
Latin America is routinely treated as a back-up region. The genetics, the demographics, the regulatory frameworks and the operational track record all say otherwise. Here is the evidence.
The premise that a retinal indication is "low prevalence in Latin America" usually rests on epidemiological literature drawn from Mexican-American and Central American populations. Those cohorts are not representative of the Southern Cone, where autosomal European ancestry runs between 67% and 82%.
What exists is a regional under-sampling problem, not a genuinely low prevalence. For sponsors, that gap is the opportunity.
The at-risk population base is already there. Latin America and the Caribbean have 65.4 million people aged 65 or older — comparable in scale to the United States, and set to double by 2050. Argentina alone has 13.1% of its population aged 65 or older, among the highest rates in the region.
And the region is a market, not only a recruitment ground: its four largest markets operate universal or near-universal coverage with established reimbursement pathways for retinal biologics.
Latin American countries should be built into the recruitment strategy from the start — not added as a rescue region once global enrolment is already behind schedule.
Regional frameworks are converging on ICH standards and moving towards regulatory reliance. Argentina joined ICH in June 2024 and adopted E6(R3) through Disposition 7516/2025; Brazil has been a member since 2016 and adopted E6(R3) in January 2025; Mexico joined in 2021 and now recognises prior FDA, EMA, MHRA and Health Canada approvals; Colombia is incorporating reliance starting with amendment approvals.
The best-characterised susceptibility genes for AMD and geographic atrophy — CFH, ARMS2/HTRA1, C3, C2/CFB, APOE — are all autosomal. They are inherited in equal proportions from both parents.
That matters in Argentina, where historical admixture was strongly sex-biased: the Y chromosome is 94% European while maternal mtDNA is mostly Native American. Judging genetic risk by surname, phenotype or self-reported ethnicity therefore underestimates the disease systematically.
In genetic terms, a typical Buenos Aires patient is closer to a European than to a "Hispanic" in the sense that term carries in North American epidemiology.
Direct epidemiological data support this. In the reference Argentine case-control study (Nano et al., Córdoba, n=350, mean age 75), roughly half of AMD cases were the dry form, with risk factors and effect sizes consistent with the European literature — and mestizo ancestry appearing as a protective factor.
The DERBY trial, Apellis Pharmaceuticals (NCT03525613). One of the two pivotal studies behind the 2023 FDA approval of pegcetacoplan — the first approved therapy for geographic atrophy.
Argentina was brought in late, as a rescue country, when global recruitment was struggling to meet enrolment targets within the planned timeline.
Within six months of active recruitment across eleven Argentine sites, the contribution was substantial in both screening volume and conversion to enrolment — roughly a fifth of the trial's global enrolment, generated in a small fraction of its total recruitment window.
The screening-to-enrolment conversion rate was at or above industry benchmarks for geographic atrophy studies, in a population naïve to comparable treatments.
This is not a projection. When a sponsor needed patients with image-confirmed geographic atrophy willing to enter a phase 3 trial involving intravitreal injections, they found them in Argentina — quickly. If prevalence in the region were truly low, that recruitment would have been impossible.
Key strategic partners
FAROS operates inside a wider regional ecosystem. Our closest strategic partnership gives sponsors access to a continent-wide alliance of ophthalmology research centers.
Americas' Research Alliance is a unified alliance for ophthalmology research in Latin America. It connects global sponsors with the region's leading ophthalmology research centers, bringing together investigators and industry partners to advance retinal therapies.
The alliance strengthens the regional clinical research ecosystem by promoting best practices, fostering collaboration between centers, and positioning Latin America as a trusted destination for high-quality ophthalmology clinical trials. Its work spans retinal disease research — macular degeneration and diabetic retinopathy among them — clinical trial management and support, investigator and sponsor collaboration, and training and knowledge exchange across the region.
Who we are
A senior team built specifically for ophthalmology clinical research in Latin America. Further appointments will be announced shortly.
Physician and regulatory specialist in clinical research across Latin America, with direct working experience of the ANMAT, ANVISA, INVIMA and COFEPRIS submission pathways. Leads FAROS operations and regulatory strategy for the region.
Clinical research professional with experience in clinical trial coordination and study operations. Supports site feasibility, study start-up, regulatory processes, documentation management, and operational oversight while ensuring compliance with sponsor requirements, regulatory standards, and Good Clinical Practice. Dedicated to delivering high-quality support throughout every stage of the clinical trial lifecycle.
Certified Public Accountant with 20+ years in accounting, tax, and finance across multinational and shared-services environments in telecommunications, clinical research, agriculture, construction, and fintech.
What our strategic partners say
“Good science is good science, it doesn’t matter who did it.”
Contact
Tell us about your protocol. Every inquiry is answered by a retina-specialized team.
