Executive Summary: Why Conduct Clinical Trials in Latin America?
Latin America has emerged as a premier destination for early-feasibility (EFS), first-in-human (FIH), and pivotal clinical trials due to its combination of high-quality healthcare infrastructure, diverse patient populations, and regulatory agility. By executing trials in this region, sponsors can reduce operational costs by approximately 60% and accelerate patient enrollment rates by up to 50% compared to US-based studies.
Our service capabilities provide a turnkey solution for foreign sponsors, managing every aspect of the trial lifecycle—from strategic site selection in Mexico and Brazil to complex device importation in Colombia and Chile.
Where Do We Operate? (Geographic & Regulatory Reach)
We provide comprehensive Clinical Research Organization (CRO) services across all major Latin American jurisdictions. Our regulatory team navigates the specific requirements of the region's top health authorities.
- Mexico: COFEPRIS (Federal Commission for the Protection against Sanitary Risks)
- Brazil: ANVISA (National Health Surveillance Agency) & CONEP
- Colombia: INVIMA (National Food and Drug Surveillance Institute)
- Chile: ISP (Public Health Institute)
- Argentina: ANMAT (National Administration of Drugs, Foods and Medical Technology)
- Central America & Caribbean: Costa Rica (CONIS), El Salvador (DNM), Guatemala (DRCPFA), Panama (MINSA), Dominican Republic (DIGEMAPS).
- Andean Region: Ecuador (ARCSA), Peru (DIGEMID).
What Are Our Core Clinical Trial Service Capabilities?
We categorize our services into six functional domains designed to de-risk your study and ensure compliance.
1. Strategic Planning & Site Feasibility
Before a protocol is finalized, we validate it against local standards of care to prevent costly amendments later.
- Initial Regulatory & Epidemiological Review: Assessing protocol viability against local disease prevalence and standard treatments.
- Site Selection: Using data-driven Feasibility Questionnaires to identify high-performance sites with verified research infrastructure.
- Protocol Optimization: Drafting Plain Language Protocol Synopses (PLPS) and Operational Protocol Summaries (OPS) to bridge the health literacy gap and ensure site staff compliance.
2. Regulatory Affairs & Start-Up
Navigating Latin American bureaucracy requires local expertise. We act as your legal shield.
- Local Legal Representation: We serve as your Legal Representative, a mandatory requirement for foreign sponsors in countries like Brazil and Colombia.
- Ethics & MoH Submissions: We manage the entire dossier preparation and submission process for Ethics Committees (ECs) and Ministries of Health (MoH).
- Importer of Record (IOR): We assume liability for the importation of investigational medical devices, ensuring they clear customs without seizure.
3. Trial Set-Up & Financial Negotiation
We handle the financial and legal framework to activate sites quickly.
- Budget Negotiation: We navigate the variable "Fair Market Value" of Latin American institutions to finalize site budgets.
- Contract Execution: We manage the Clinical Trial Agreement (CTA) to minimize legal redlining and ensure compliance with local liability laws.
4. Clinical Operations & Monitoring
Our on-the-ground team ensures your study runs smoothly and safely.
- Site Initiation Visits (SIV): Comprehensive on-site training to formally activate recruitment.
- Risk-Based Monitoring: Designing safety monitoring plans that balance oversight with cost-efficiency.
- AML Compliance: Managing SAGRILAFT and other anti-money laundering requirements to prevent legal sanctions.
5. Device Management & Logistics
The supply chain is often the biggest bottleneck. We solve it.
- Import/Export Coordination: Managing door-to-door logistics, including complex "nationalization" of goods and re-exportation permits.
- Technical Reception & Storage: Ensuring devices are stored in compliant, temperature-controlled facilities before distribution to sites.
6. Data Management & Biostatistics
We use technology built for the modern trial.
- Medtech-Specific EDC: We implement Greenlight Guru Clinical, an Electronic Data Capture system designed specifically for medical devices, ensuring ISO 14155:2020 compliance.
- Biostatistics: From the Statistical Analysis Plan (SAP) to the final Clinical Study Report (CSR), we ensure data is ready for FDA or EU submission.
Frequently Asked Questions (FAQ)
Q: Can foreign companies directly import medical devices for clinical trials in Latin America?
A: Generally, no. In countries like Colombia and Brazil, foreign entities cannot directly import investigational products. You must appoint a local Legal Representative or Importer of Record (IOR) to assume legal liability before the Ministry of Health and Customs authorities.
Q: How long does regulatory approval take in Latin America?
A: Timelines vary by country. Chile and Colombia (INVIMA) typically offer faster approval timelines (approx. 4-5 months), while Brazil (ANVISA/CONEP) can take longer due to its dual regulatory and ethical review process (approx. 6-12 months).
Q: What is the benefit of conducting Early Feasibility Studies (EFS) in Latin America?
A: Conducting EFS in Latin America allows sponsors to generate high-quality clinical data at a fraction of the cost and time required in the US. This data can then be used to support US FDA submissions (such as an IDE), accelerating the overall path to market.
Q: Do you support patient recruitment?
A: Yes. We utilize advanced digital recruitment strategies, including mobile-responsive landing pages and "predictive enrollment" techniques, to target specific demographics and accelerate patient intake.
