US + Latin America Cardiovascular Trial Strategy — A Sponsor's Cross-Border Guide

This guide is for sponsor clinical-operations leads and biotech founders evaluating whether a hybrid design fits their cardiovascular trial. It draws on a decade of running first-in-human and pivotal cardiovascular work across both regions through Amavita Research (US) and bioaccess® (Latin America).

When a hybrid US + Latin America design makes sense

Cross-border designs aren't right for every trial. They make sense when at least two of these conditions hold:

• You need to reach first-patient-enrolled faster than US-only sites can deliver. Latin America countries with established regulatory pathways (Colombia, Argentina, Chile, Mexico) can typically reach FPE in 12-18 weeks from CDA — competitive with the fastest US sites and faster than many AMCs.
• You need ethnic and demographic diversity that US-only enrollment can't easily produce. FDA's Diversity Action Plans Final Guidance (June 2024) puts pressure on sponsors to enroll cohorts that reflect the disease's actual prevalence patterns. Latin America cohorts naturally produce Hispanic/Latino patient data that US sites often struggle to recruit. See our companion guide on FDA DAP and cardiovascular site selection.
• You're capital-sensitive and the per-patient cost differential is meaningful at your sample size. Latin America cardiovascular trial costs typically run 30-50% below US benchmarks. At N=500, that's not academic.
• You're running a first-in-human protocol where Latin America's regulatory pathway is faster. Colombia's INVIMA pathway for early-phase cardiovascular work is typically 4-8 weeks for well-prepared submissions. The US IND pathway typically takes longer for novel mechanisms.
• You need a Phase 1 or feasibility cohort fast, then expand to US pivotal. A staged design — Phase 1/early Phase 2 in Latin America, pivotal in US — is one of the most efficient capital structures available for novel cardiovascular treatments.

When it doesn't make sense

Be honest about when cross-border isn't the right answer:

• Your trial is a registry or Phase 4 commitment study and the FDA wants US-population data specifically
• Your protocol requires US-only labeling considerations that won't accept non-US data
• Your investigational product can't be reliably shipped to the LATAM site (cold-chain failures are real)
• Your sponsor team doesn't have bandwidth to coordinate two regional teams, and you don't want to hire a CRO to bridge

If any of these hold, US-only is the right call.

The five strategic pillars of cross-border execution

Pillar 1: Regulatory pathway selection

Each Latin American country has a different regulatory pathway, with different speeds, different documentation expectations, and different patient-protection frameworks. The key options for cardiovascular work:

• Colombia (INVIMA): Strong cardiovascular ecosystem in Bogotá and Medellín. Pathway is typically fast (4-8 weeks for well-prepared submissions). Strong Spanish-language informed-consent infrastructure. Established for first-in-human work.
• Argentina (ANMAT): Mature regulatory framework. Typically slower than Colombia (8-16 weeks) but well-respected by global agencies.
• Chile (ISP): Excellent for cardiology and oncology. Strong reputation for trial conduct quality. Pathway is typically 6-12 weeks.
• Mexico (COFEPRIS): Largest patient population but most variable on timelines.

A bridging CRO with local regulatory experience does the country selection based on your protocol's specific needs (indication, device vs. drug, FIH vs. pivotal).

Pillar 2: Protocol harmonization

The single protocol runs in both regions. Key harmonization decisions:

• Inclusion/exclusion criteria — must be identical or differ in ways pre-specified in the statistical analysis plan
• Primary and secondary endpoints — identical, measured the same way at both regions
• Data capture standards — same eCRF, same central labs where feasible, same imaging core lab
• Statistical analysis plan — pre-specifies how regional data will be pooled, what pre-specified subgroup analyses will be done, how heterogeneity will be addressed

The harmonization work happens upfront. Once the protocol is locked, regional teams execute against the same template.

Pillar 3: PI selection and training

Latin America cardiology has produced world-class investigators, but trial conduct quality varies by site. Cross-border CROs filter for sites with:

• Active English-language documentation capability
• ICH-GCP training current and verifiable
• Prior FDA inspection-ready trial history
• PI continuity (same problem as US sites — networks vs. independent practices)
• Active patient flow in the indication (not database-recruited)

The PIs at each region attend the same investigator meeting. Same protocol training, same source-document expectations, same monitoring cadence.

Pillar 4: Operational integration

The two regional arms need to feel like one trial to the sponsor. That requires:

• Single data lake — both regions feed the same eCRF / data management system
• Coordinated monitoring — same CRA standards, monitoring frequency, query response SLAs
• Coordinated drug supply — IP shipping logistics planned at protocol design, not retrofit
• Coordinated safety reporting — adverse events from both regions flow into the same safety database, reviewed by the same DSMB
• Single sponsor-facing point of contact — typically the lead CRO or, in our case, the bioaccess®/Amavita Research integrated team

When this integration is loose, the trial functionally splits into two trials. When it's tight, it operates as one.

Pillar 5: Data analysis and FDA submission strategy

The statistical analysis plan should pre-specify:

• Pooled analysis as the primary inferential approach
• Pre-specified regional subgroup analyses
• Tests of heterogeneity (with thresholds)
• Sensitivity analyses excluding either region

When properly designed and pre-specified, FDA reviewers accept pooled US + Latin America data routinely for cardiovascular indications. The cases where they push back are when the analysis plan wasn't pre-specified, when regional differences in disease background or standard of care weren't documented, or when the LATAM sites' trial conduct quality wasn't documented to FDA standards.

This is solvable with planning. It's not solvable in cleanup.

A practical example: hypertension trial design

Suppose you're running a Phase 2 hypertension trial for a novel RNAi therapeutic. You want N=300, diverse cohort, FPE within 6 months of contract execution.

US-only path: 12-15 sites at $25,000-$40,000 per patient. Enrollment timeline 12-18 months. Hispanic/Latino representation depends on site selection.

US + LATAM hybrid path: 4 US sites (including Amavita Research) at $25,000-$40,000 per patient + 6 LATAM sites (Colombia, Chile, Argentina) at $12,000-$20,000 per patient. Enrollment timeline 8-12 months. Hispanic/Latino representation naturally high. Total budget 25-35% lower than US-only.

The math gets better as N gets larger.

How Amavita Research and bioaccess® work together

Amavita Research is the US arm — an independent investigator-led cardiovascular trial site in North Miami Beach, FL, embedded inside amavita Heart and Vascular Health®. bioaccess® is the Latin America arm — a first-in-human CRO with operations across Colombia, Argentina, and other regional markets.

The same leadership team coordinates both. Julio G. Martinez-Clark is CEO of bioaccess® and Head of Growth & Strategy at Amavita Research. Dr. Pedro Martinez-Clark, MD, FACC is a Principal Investigator at Amavita and a long-tenured cardiovascular research veteran with deep Latin America regulatory experience.

For sponsors, this means:

• A single contracting party for protocols that span both regions
• A single point of contact for protocol amendments, safety reporting, and operational decisions
• A coordinated data flow without third-party CRO handoffs between regions
• US trial conduct quality (IAOCR GCSA, ICH-GCP E6(R3), zero FDA Form 483 findings) at the US arm; equivalent quality framework at the LATAM arm

Published bioaccess® FIH client outcomes

Publicly-disclosed bioaccess® FIH client deliveries (as stated by bioaccess®) include:

• Axoft — 4 brain-computer interface implants in 2.5 years
• Newrotex — world's first silk nerve guide human implant
• PAVmed — CarpX™ device with FDA Breakthrough Device Designation using LATAM clinical data
• Avantec Vascular — Sangria™ venous remodeling system FIH in El Salvador

Across the full portfolio, bioaccess® reports 50+ delivered FIH programs since 2010 (from a base of hundreds of consulted companies) across 10 Latin American markets. Sponsors running US + Latin America hybrid cardiovascular trial designs can engage the integrated Amavita Research + bioaccess® relationship through a single counterpart.

Learn more about the sister-organization relationship →

Practical next steps

If you're evaluating a hybrid US + Latin America design for a cardiovascular protocol:

1. Send a protocol synopsis to /contact-sponsor. We respond within 48 business hours with regional feasibility, indicative timelines, and cost ranges.
2. Schedule a 30-minute strategy call with Julio or with one of our regional leads to walk through your specific protocol and design.
3. If there's a fit, we move to CDA within 5 business days for the Amavita US arm and within 7-10 business days for the bioaccess® LATAM arms.

You can also explore the full Amavita Research site at amavitaresearch.com and the bioaccess® site at bioaccessla.com.

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About the author: Julio G. Martinez-Clark is Head of Growth & Strategy at Amavita Research and CEO of bioaccess®, a Latin America first-in-human CRO. He has spent over a decade structuring cross-border cardiovascular trial designs for US and global sponsors. Connect on LinkedIn or read more at juliomartinezclark.com.