For Sponsors
Cardiovascular Phase 1 Unit — Kendall, Miami
A cardiovascular site that also runs Phase 1. Phase 1 studies for cardiovascular indications, conducted in an ASC setting at our affiliated Advanced Cardiovascular of Miami.
Cardiovascular early-phase and first-in-human studies, run by practicing cardiologists with cath-lab and interventional-suite access inside a Miami cardiovascular surgery center.
- 8 monitored observation beds with continuous ECG telemetry inside the affiliated ASC.
- Interventional, structural-heart and electrophysiology investigators on one team.
- First-in-human experience through bioaccess®, with a path to U.S. expansion at Amavita Research as prime contractor.
Amavita Research operates a cardiovascular Phase 1 unit. We work with Advanced Cardiovascular of Miami, an affiliated, licensed, Medicare-certified, AAAHC-accredited cardiovascular ambulatory surgery center in Kendall, Miami, which gives our studies direct access to a cardiovascular ASC and cath lab. Monitoring, sampling and dosing-window requirements are scoped with each sponsor during feasibility; stays are same-day and designed to fit within ASC admit-and-discharge rules.
At a glance
- Location
- Advanced Cardiovascular of Miami (affiliated ASC), 9408 SW 87th Ave, Suite 303, Miami, FL 33176 (Kendall)
- Facility
- Licensed, Medicare-certified, AAAHC-accredited cardiovascular ambulatory surgery center
- Monitored beds
- 8 monitored observation beds with continuous ECG telemetry inside the affiliated ASC
- Procedure access
- Cath lab and procedure suites within the affiliated ASC
- Study setting
- Same-day ASC setting; study requirements confirmed during feasibility
What we run at the Phase 1 unit
Medtech device EFS / FIH
- Phase 1 cardiovascular device studies, scoped per protocol
Biopharma drug FIH and Phase 1a/1b
- Phase 1 cardiovascular drug studies, scoped per protocol
Expanding therapeutic areas
The Phase 1 unit is cardiovascular-led — that is the headline and the differentiation. The unit's monitored beds, continuous telemetry, and feasibility process also support Phase 1 studies in other therapeutic areas, scoped per protocol during feasibility. Neurology is an active site expansion:
- Neurology specialist search underway to anchor the therapeutic area at the site.
- Community health-center partnerships extend patient access for neurology protocols.
- No neurology-specific Phase 1 infrastructure is claimed — studies are scoped honestly during feasibility.
Multi-PI coverage by indication
- Interventional cardiology, coronary, peripheral — Dr. Pedro Martinez-Clark, MD, FACC. Harvard-trained interventional cardiologist; PI on GREAT (Golazo® below-the-knee atherectomy Phase 3).
- Structural heart consultative — Dr. William W. O'Neill, MD, FACC. senior principal investigator and interventional cardiologist with a structural-heart (TAVR) research background; performed structural-heart (TAVR) research; PROTECT II national PI, PROTECT IV Steering Committee member, and PARTNER site PI at Henry Ford.
- Electrophysiology — Dr. Hans C. Rutzen-Lopez, MD. Triple-board-certified electrophysiologist (Internal Medicine, Cardiovascular Disease, Clinical Cardiac Electrophysiology, plus National Board of Echocardiography).
- General cardiology co-management — Yasnaya Cruz-Santiago, APRN; Orlando Ortega-Izquierdo, APRN. Bilingual EN/ES.
Sister-organization FIH track record
Through our sister organization bioaccess® — a Latin America first-in-human CRO operating across 19 Latin American and Caribbean markets since 2010 — sponsors have access to a delivery team with 50+ executed FIH programs. Recent publicly-disclosed bioaccess® client outcomes include:
- Axoft — 4 brain-computer interface implants in 2.5 years; seed-stage to clinical
- Newrotex — world's first silk nerve guide human implant; 2-week regulatory approval
- PAVmed — CarpX™ device; FDA Breakthrough Device Designation using Latin American clinical data
- Avantec Vascular — Sangria™ venous remodeling system; FIH completed in El Salvador
These outcomes were delivered by bioaccess® (the sister organization), not by Amavita Research directly. For sponsors running US + Latin America hybrid Phase 1 designs, Amavita Research's Kendall Phase 1 Unit serves as the US arm and bioaccess® serves as the LATAM arm under a single coordinated counterpart.
Cross-border US + Latin America Phase 1 design
For sponsors running integrated US + Latin America Phase 1 programs, Amavita Research coordinates with sister organization bioaccess® (Latin America first-in-human CRO based in Colombia). Common pattern: LATAM arm (bioaccess®) — fast regulatory pathway via INVIMA. US arm (Amavita Phase 1 Unit, Kendall) — FDA regulatory anchor; expansion cohort post-FIH. Single integrated protocol, harmonized eCRF, coordinated SAE reporting. Single sponsor counterpart for both arms via Julio G. Martinez-Clark, Chief Executive Officer (CEO) of Amavita Research and CEO of bioaccess®.
Part of the same research group as bioaccess®
Amavita Research is part of the same research group as bioaccess®, a first-in-human CRO operating across the Americas, so sponsors can plan integrated Americas programs through one team.
Quality and compliance
- IAOCR GCSA-certified (Feb 2025) (GCSA-certified (Feb 2025))
- ICH-GCP E6(R3) compliant
- SCRS member
- HIPAA-compliant; BAA-ready
- Bilingual coordinators (English / Spanish / Haitian Creole / Portuguese)