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amavitaRESEARCH

For Sponsors

Site Capabilities

Cardiovascular trial infrastructure at Amavita Research — North Miami Beach, FL

Amavita Research operates inside amavita Heart and Vascular Health®, a full-service cardiology practice with on-site procedural and diagnostic infrastructure. The same physicians who serve as Principal Investigators on trials see cardiology patients every business day, which gives the site continuous patient flow and immediate access to procedural resources. Below is a summary of the infrastructure available to sponsors for cardiovascular feasibility, pivotal, and first-in-human protocols.

Looking for the process side — feasibility, start-up, enrollment, conduct, monitoring, and close-out? See Trial Services →

New: See our Phase 1 unit — 8-bed overnight cardiovascular Phase 1 / FIH unit at the Kendall ASC →

Procedural capabilities

Cardiac catheterization lab
Direct access to amavita Heart and Vascular Health® cath-lab and the affiliated Advanced Cardiovascular of Miami ambulatory surgical center. Coronary angiography, PCI, IVUS, OCT, peripheral angiography, peripheral atherectomy.
Electrophysiology
Triple-board-certified EP on staff (Dr. Hans C. Rutzen-Lopez, MD). Capability for AFib screening protocols, ICD/CRT-D device follow-up, ECG-gated trial assessments.
Structural heart consultation
Dr. William W. O'Neill, MD, FACC — structural heart leadership (TAVR/Impella legacy). Consultative role on high-acuity structural protocols.
Peripheral intervention
Below-the-knee atherectomy capability via PI Dr. Pedro Martinez-Clark, MD, FACC. Active Phase 3 PAD trial enrollment (GREAT/Golazo®).
IV infusion suite
On-site IV infusion bays for trial dosing protocols (e.g., IV ferric derisomaltose, IV inotropes, IV diuretics). Trained CRC supervision.
Subcutaneous and oral dosing
Routine SC/PO trial dosing under PI supervision; dose-administration logs maintained per ICH-GCP.

Diagnostic capabilities

Echocardiography
Transthoracic echo on-site; transesophageal echo via affiliated facility. Sponsor-provided core-lab transmission supported.
Ambulatory blood pressure monitoring
24-hour ABPM available for hypertension protocols (e.g., ZENITH zilebesiran).
ECG (12-lead and Holter)
12-lead ECG on every clinic visit; 24-hour, 48-hour, and event-monitor Holter available. Sponsor-provided central ECG-reading supported.
Cardiac biomarkers
Same-day venous draws for NT-proBNP, troponin, hs-CRP. Central-lab kit handling and sample shipping per IATA training.
Imaging coordination
Cardiac CT and cardiac MRI scheduled via affiliated imaging centers; direct integration with sponsor imaging core labs.

Operational capabilities

IRB strategy
Central IRB preferred (WCG, Advarra). Site has experience with both. Local IRB also available if sponsor requires.
Contract execution
Standard CTA template available; turnaround typically 5–8 weeks from sponsor's first draft to fully-executed contract for trial types already qualified.
Source documentation
EHR + dedicated trial source documents per protocol. eSource-compatible.
Monitoring
On-site and remote monitoring supported. Dedicated CRC workspace with secure network access.
Drug accountability
Temperature-monitored IP storage; chain-of-custody logs; on-site sponsor-monitored IP destruction or return shipping.
Patient retention
In-network cardiology practice means patients are already attached to the practice for routine cardiology care — drop-out rates lower than database-recruited cohorts.

Quality and compliance

  • IAOCR GCSA recertified May 2026 (valid through Feb 2027)
  • ICH-GCP E6(R3) compliant
  • SCRS (Society for Clinical Research Sites) member
  • Zero FDA Form 483 findings to date
  • HIPAA-compliant patient handling; BAA-ready for sponsor data exchange
  • Spanish/Haitian Creole/Portuguese bilingual staff for Miami's multilingual patient population

Sub-specialty coverage

Cross-border trial designs

Sponsors running U.S.-Latin America hybrid protocols can integrate Amavita Research as the U.S. arm and bioaccess® as the Latin America arm under a single coordinated design. bioaccess® is a Latin America first-in-human CRO with operations in Colombia and other regional markets. Julio G. Martinez-Clark, CEO of bioaccess® and Head of Growth & Strategy at Amavita Research, coordinates these dual-region engagements.

New: Need a Latin America arm too? Read our cross-border strategy guide →

New: FDA DAP and cardiovascular site selection →

Discuss your protocol with Amavita Research →View our active cardiovascular trials →Meet our Principal Investigators →