---
title: "Sponsor FAQ — Decisions, Timelines, Capacity | Amavita Research"
url: https://md.amavitaresearch.com/faq-sponsors
canonical: https://www.amavitaresearch.com/faq-sponsors
schema_type: FAQPage
last_updated: 2026-05-12
---

# Sponsor FAQ — Amavita Research

Concrete answers for sponsors evaluating Amavita Research as a Miami site for first-in-human, feasibility, and pivotal cardiovascular trials.

## 1. Why Amavita Research vs. an academic medical center site?

Amavita Research is the clinical-research arm of amavita Heart and Vascular Health® — the largest independent cardiovascular practice in South Florida. Investigators see eligible patients in clinic every day, so screening and enrollment ride on the same workflows as standard-of-care visits. No academic affiliation overhead, no internal politics around competing trials, no shared cath-lab schedules with surgical training programs. Single PI decision-speed, full FACC-credentialed roster, and ICH-GCP E6(R3)-compliant infrastructure.

## 2. Who are the principal investigators?

Dr. William W. O'Neill, MD, FACC — Chief Medical Officer & Senior Principal Investigator. TAVR pioneer; performed the first TAVR in the U.S.; National PI on Edwards PARTNER, Protect II, and Protect IV. Dr. Pedro Martinez-Clark, MD, FACC — Founder and Lead Investigator. Harvard-trained interventional cardiologist; Worldwide PI on the Percutaneous Mitral Valve Annuloplasty trial. Dr. Hans C. Rutzen-Lopez, MD — Sub-Investigator, Cardiac Electrophysiology. Triple board-certified.

## 3. What therapeutic areas can Amavita Research run?

Coronary revascularization, structural heart (TAVR, mitral, tricuspid), heart failure, peripheral artery disease and atherectomy, cardiac electrophysiology (atrial fibrillation, leadless pacing, VT ablation), pulmonary embolism response, and adjacent interventional cardiology indications. Imaging-heavy protocols supported through the in-network imaging infrastructure of amavita Heart and Vascular Health®.

## 4. How fast can Amavita Research get to first patient enrolled?

5–8 weeks contract-to-first-patient for trial types already qualified at the site. Add 2–3 weeks if the protocol requires net-new IRB submission. Patient screening starts the moment IRB approves.

## 5. How many patients can Amavita Research enroll?

Direct access to the patient panel across amavita Heart and Vascular Health®. For a typical 20-patient cardiovascular feasibility study, screening-to-enrolled conversion is 6–10 weeks. Sponsor receives weekly KPI dashboards via Monday.com.

## 6. Are Amavita Research's investigators trial-active or just credentialed on paper?

Trial-active. Every PI carries an active patient panel at amavita Heart and Vascular Health® clinics. No "rent-a-PI" arrangements, no investigator who hasn't run a cardiovascular trial in the last 24 months.

## 7. What quality and compliance certifications does Amavita Research carry?

IAOCR GCSA-certified site. ICH-GCP E6(R3) compliant SOPs. Society for Clinical Research Sites (SCRS) member. SOP SITE-107 (KPI tracking and audit trail) enforced on every active study.

## 8. How does Amavita Research handle source data verification and monitoring?

Designated CRC ownership per protocol, Monday.com-tracked KPIs for visit-window adherence, dedicated office space for sponsor monitor visits, prep packets shipped before each visit. Source data verified weekly internally before sponsor monitor arrival.

## 9. What's Amavita Research's audit and inspection history?

Zero FDA inspection findings. Every sponsor audit since site opening has closed with zero major findings. Detailed summaries available on request under MNDA.

## 10. Can Amavita Research support hybrid US + Latin America trial designs?

Yes. Amavita Research integrates with bioaccess®, the Latin America first-in-human CRO led by Amavita's CEO Julio G. Martinez-Clark. Sponsors can run a US arm at Amavita and a Latin American arm at bioaccess under the same protocol.

## 11. What's the cost compared to other Miami cardiovascular sites?

Typically competitive with academic Miami sites and 20–30% below high-end private-equity-backed site networks. Differential comes from being an independent practice — no academic overhead, no MSO carve-out, no surgical-training program competing for cath-lab time.

## 12. Who owns the data, IP, and trial results?

The sponsor. Amavita Research operates as a contracted clinical research site only. The sponsor retains the protocol, data, and any IP arising from the study.

## 13. Can Amavita Research support imaging-heavy trials?

Yes. On-network access to echocardiography, fluoroscopy, CT angiography via amavita Heart and Vascular Health®. Sponsor-specific imaging core labs accommodated.

## 14. How do I start a conversation with Amavita Research about a trial?

Email srubio@amavita.health or use https://www.amavitaresearch.com/contact-sponsor. First conversation is typically a 30-minute feasibility call. Response within one business day. Under MNDA, investigator CVs, site qualification packets, and prior-trial enrollment metrics available.