Family-owned CRO · 100% dedicated to LATAM since 1999
Real-world evidence, executed in LATAM.
We are the boutique CRO specialized in Phase IV, observational and real-world evidence studies across Latin America — with local teams, fast start-ups, and import/export logistics solved from day one.
Services
Specialists in the phase where your product meets the real world.
We don't try to be everything to everyone. We execute late phase studies and the functions that make them possible in the region: local monitoring, project management, and regulatory supply logistics.
Late Phase, Medical Affairs & Real-World Evidence
We design and execute post-authorization studies end to end: from feasibility and country-by-country regulatory strategy to database lock and final report. Eight of our last fourteen trials were Phase IV, with a focus on oncology and respiratory.
- Interventional Phase IV and extension studies
- Prospective and retrospective observational studies
- PASS / PAES and post-authorization commitments
- Patient registries and multicenter chart reviews
- Medical Affairs support: publications, KOLs, local evidence
Clinical monitoring & site management
Local CRAs in Argentina, Peru and Brazil, with additional coverage in Chile, Ecuador, Colombia, Mexico and Central America/Caribbean. Onsite, remote, hybrid and risk-based monitoring (RBM), with experience in DCT tools, eTMF and EDC integration.
Project management
Regional study leadership with a single point of contact: timelines, vendors, ethics committees and health authorities coordinated from within the region, in your time zone.
Clinical supply import / export
Local representation and import/export licenses for IMP, kits, comparators and equipment. Regulatory logistics stops being the start-up bottleneck.
Import / Export
From import permit to the site's door.
Clinical supply is where LATAM studies lose weeks. We treat it as a critical path of its own, with local owners in every country.
Licenses & permits
Import license processing before ANMAT, ANVISA and DIGEMID; local representation when the sponsor has no legal entity in the country.
Customs clearance
Coordination with brokers and customs agents; pro-forma documentation, tariff classification and research-use exemptions.
Depot & cold chain
Receipt at licensed depots, GDP storage and temperature control documented end to end.
Distribution to sites
Delivery to sites on committed timelines, with batch-level traceability and supply reconciliation throughout the study.
Re-export or destruction
Documentary closure of the loop: return, re-export or certified destruction per local regulations and sponsor requirements.
IMP & comparators
Investigational product, commercial comparators and rescue medication, managed under a single documentary circuit.
Kits & equipment
Lab kits, devices and study-critical equipment, including temporary imports.
Biological samples
Sample export to central labs with the corresponding health permits and IATA logistics.
Coverage
Direct operations where it matters. A validated network where it's needed.
Argentina AR
Our home base. Ethics review and ANMAT run in parallel under Disposition 7516/2025, with approval timelines capped at 62 working days.
Direct operationsBrazil BR
Local team in the region's largest market. Law 14.874/2024: INAEP-accredited ethics committees and parallel ANVISA review, with advance import of supplies.
Direct operationsPeru PE
Local operations with INS and DIGEMID experience, including clinical supply importation.
Direct operationsWhy LATAM: 40–60% faster enrollment and 20–30% lower costs than US/EU sites, with ICH E6 (R3)-harmonized regulatory frameworks and recently shortened timelines in Argentina and Brazil.
Real flexibility
Full-service or functional (FSP) models, adapting to the sponsor's SOPs and technology. We scale the team to the study — not the other way around.
Transparent pricing
Clear budgets, no opaque units, no surprise change orders. What we quote is what we invoice.
Senior talent, direct access
You talk to the people doing the work. No account-management layers between the sponsor and the study team.
Why a family-owned CRO
Your project becomes our own.
In a global CRO, a study like yours is one more line in a portfolio of hundreds. In a family-owned company, every study we take on carries our name and our reputation. So we care for it as our own: your deadlines are our deadlines, your problems reach us before they reach your desk, and the team that welcomes you at kick-off is the same one that signs the close-out.
In a recent Phase III in Brazil, the sponsor changed project managers several times. Our local team — intact from start to finish — was the backbone that carried execution across all 18 sites.
If something threatens your timeline, we escalate it — you don't discover it in the monthly report. Owning the problem is part of the service.
We take on the projects we can truly care for. With us, you'll never be a big CRO's smallest client.
Let's begin
Tell us about your study.
We reply within 48 hours.
Share your project details and our team will prepare a tailored proposal: scope, countries, regulatory timeline and estimated budget.
contact@salud-solutions.com
+54 11 4962-4263
