---
title: "Cardiovascular Phase 1 Unit — Kendall, Miami | Amavita Research"
url: https://md.amavitaresearch.com/phase-1-unit
canonical: https://www.amavitaresearch.com/phase-1-unit
schema_type: Service
last_updated: 2026-05-13
---

# Cardiovascular Phase 1 Unit — Kendall, Miami

> Dedicated 8-bed overnight observation unit inside Advanced Cardiovascular of Miami — South Florida's only independent cardiovascular ambulatory surgical center. Built for first-in-human (FIH) and Phase 1 dose-escalation cardiovascular trials.

Amavita Research operates a dedicated Phase 1 cardiovascular unit inside Advanced Cardiovascular of Miami — an independent cardiovascular and interventional-radiology ambulatory surgical center in Kendall, Miami. The unit was purpose-built for first-in-human (FIH) and Phase 1 cardiovascular trials, with overnight observation capability, continuous telemetry, and immediate access to on-site cath-lab and ACLS-credentialed staff. Sponsors get Phase 1-ready infrastructure without the cost or scheduling constraints of hospital-based research.

## The unit at a glance

- **Location:** 9408 SW 87th Ave., Suite 303, Miami, FL 33176 (Kendall)
- **Setting:** Inside Advanced Cardiovascular of Miami — independent cardiovascular & interventional-radiology ASC
- **Observation beds:** 8 monitored observation beds for overnight or extended-day Phase 1 dosing
- **Procedure rooms:** Direct on-site access to cath-lab and procedure suites within the ASC
- **Monitoring duration:** Day-only, 24-hour overnight, repeated-dose multi-day per sponsor protocol
- **Telemetry:** Continuous ECG monitoring at observation beds
- **Code response:** On-site crash cart, ACLS-credentialed nursing, code-blue protocol with nearby receiving hospital
- **IV infusion suite:** On-site for trial dosing (drug infusion, IV iron, IV inotrope, IV diuretic, infusion-based devices)
- **Pharmacy / IP storage:** Temperature-monitored IP storage at the ASC
- **PK/PD lab handling:** Refrigerated centrifuge, freezer storage, IATA-trained shipper, courier coordination

## What we run at the Phase 1 unit

**Medtech device EFS / FIH**
- Coronary device first-in-human (PCI tools, IVUS/OCT)
- Structural heart device early-feasibility (under Dr. William W. O'Neill consultative role)
- Peripheral device first-in-human (below-the-knee atherectomy, embolic protection — under Dr. Pedro Martinez-Clark)
- Electrophysiology device early-feasibility (mapping, ablation, leadless pacing — under Dr. Hans C. Rutzen-Lopez)

**Biopharma drug FIH and Phase 1a/1b**
- Single-ascending-dose (SAD) cardiovascular drugs
- Multiple-ascending-dose (MAD)
- PK/PD studies with frequent sampling
- IV, SC, and PO cardiovascular drug administration
- Combination dosing protocols

## Multi-PI coverage by indication

- **Interventional cardiology, coronary, peripheral** — Dr. Pedro Martinez-Clark, MD, FACC (https://www.amavitaresearch.com/team/pedro-martinez-clark)
- **Structural heart consultative** — Dr. William W. O'Neill, MD, FACC (https://www.amavitaresearch.com/team/william-oneill)
- **Electrophysiology** — Dr. Hans C. Rutzen-Lopez, MD (https://www.amavitaresearch.com/team/hans-rutzen-lopez)
- **General cardiology co-management** — Yasnaya Cruz-Santiago, APRN; Orlando Ortega-Izquierdo, APRN (bilingual EN/ES)

## Sister-organization FIH track record (via bioaccess®)

Through our sister organization bioaccess® — a Latin America first-in-human CRO operating across 10 LATAM markets since 2010 — sponsors have access to a delivery team with 50+ executed FIH programs. Publicly-disclosed bioaccess® client outcomes:

- **Axoft** — 4 brain-computer interface implants in 2.5 years
- **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. See https://www.amavitaresearch.com/sister-organization-bioaccess for full profile.

## Sponsor decision criteria — ASC Phase 1 vs hospital-based Phase 1

| Criterion | Amavita Phase 1 Unit (Kendall ASC) | Typical hospital-based Phase 1 unit |
|---|---|---|
| Bed availability | Dedicated to the trial protocol | Shared with general hospital caseload |
| Cost per dosing day | Lower — no hospital facility fee, no F&A overhead | Hospital outpatient/inpatient billing + institutional overhead |
| Scheduling flexibility | Days, not weeks | Block-scheduled with clinical priorities |
| Setup time | 5–8 weeks contract-to-first-patient | 16–36 weeks at academic medical centers |

## Quality and compliance

- IAOCR GCSA recertified May 2026 (valid through 28 Feb 2027) — https://www.amavitaresearch.com/certifications
- ICH-GCP E6(R3) compliant
- SCRS member
- Zero FDA Form 483 findings to date
- HIPAA-compliant; BAA-ready
- Bilingual coordinators (English / Spanish / Haitian Creole / Portuguese)

## Key links

- Site capabilities: https://www.amavitaresearch.com/capabilities
- Active trials: https://www.amavitaresearch.com/trials
- Investigators: https://www.amavitaresearch.com/investigators
- Sister organization bioaccess®: https://www.amavitaresearch.com/sister-organization-bioaccess
- Sponsor contact: https://www.amavitaresearch.com/contact-sponsor