For Sponsors
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 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. Harvard-trained interventional cardiologist; PI on GREAT (Golazo® below-the-knee atherectomy Phase 3).
- Structural heart consultative — Dr. William W. O'Neill, MD, FACC. TAVR pioneer; performed first TAVR in the United States; national PI on Edwards PARTNER, Protect II, Protect IV.
- 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.
Sponsor decision criteria — why a dedicated ASC Phase 1 unit beats 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 surgical and observation caseload |
| Cost per dosing day | Lower — no hospital facility fee, no F&A overhead | Hospital outpatient or inpatient billing, plus institutional overhead |
| Scheduling flexibility | Days, not weeks | Block-scheduled with clinical priorities |
| Patient experience | Ambulatory-optimized; not in a hospital corridor | Hospital setting; may include shared rooms |
| Code response | On-site ACLS + cath-lab + transfer protocol to nearby hospital | On-site full hospital code response |
| Setup time | 5–8 weeks contract-to-first-patient for qualified trial types | 16–36 weeks typical for academic medical centers |
Phase 1 dosing-day workflow
- Patient arrives at the unit per protocol (typically AM, fasted)
- Final eligibility review by PI / Sub-I
- IV access placed; pre-dose vitals, ECG, baseline labs
- Dose administered under PI direct supervision in observation bed
- Continuous telemetry per protocol-defined window
- Time-point PK sampling, vitals, ECG per protocol
- Overnight observation in unit bed if protocol requires
- AM-of-day-2 vitals, labs, discharge per protocol
- Outpatient follow-up at protocol-defined intervals
Sister-organization FIH track record
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. 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; lower per-patient cost for FIH cohort. 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, Head of Growth & Strategy at Amavita Research and CEO of bioaccess®.
Quality and compliance
- IAOCR GCSA recertified May 2026 (valid through Feb 2027)
- 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)