# Amavita Research

> Miami-based cardiovascular clinical research site purpose-built for first-in-human, feasibility, and pivotal cardiovascular trials. The clinical-research arm of amavita Heart and Vascular Health® — the largest independent cardiovascular practice in South Florida. Sister organization to bioaccess®, the Latin America first-in-human CRO. ICH-GCP E6(R3)-compliant, IAOCR GCSA-certified, SCRS member.

## Key Facts

- Type: Investigator-led clinical research site (not a CRO)
- Location: North Miami Beach, Florida, USA (greater Miami metro)
- Parent organization: amavita Heart and Vascular Health® — the largest independent cardiovascular practice in South Florida
- Sister organization: bioaccess® (first-in-human CRO operating across 10 Latin American markets)
- CEO: Julio G. Martinez-Clark, MBA
- Chief Medical Officer: Dr. William W. O'Neill, MD, FACC
- Founder & Lead Investigator: Dr. Pedro Martinez-Clark, MD, FACC
- Quality framework: ICH-GCP E6(R3)
- Certifications: IAOCR GCSA-certified site, Society for Clinical Research Sites (SCRS) member, SOP SITE-107 (KPI tracking and audit trail)
- FDA inspection history: Zero findings to date

## Therapeutic Areas

Structural heart disease (TAVR, mitral valve repair and replacement, tricuspid), coronary revascularization and high-risk PCI, cardiac electrophysiology (atrial fibrillation, leadless pacing, VT ablation), heart failure, peripheral artery disease and atherectomy, cardiogenic shock, pulmonary embolism response, interventional and cath-lab study support, venous ablation.

## Principal & Sub-Investigators

Dr. William W. O'Neill, MD, FACC — Chief Medical Officer & Senior Principal Investigator. TAVR pioneer; performed the first TAVR in the United States. National Principal Investigator on Edwards PARTNER, Protect II, and Protect IV trials. Medical Director, Center for Structural Heart Disease, Henry Ford Hospital. Chief Medical Advisor, CardioElite™.

Dr. Pedro Martinez-Clark, MD, FACC — Founder and Lead Investigator. Harvard-trained interventional cardiologist with 15+ years of practice and 25+ completed clinical research trials. Worldwide Principal Investigator on the Percutaneous Mitral Valve Annuloplasty trial. Contributed to development of the Trans-Caval TAVR approach. 2023 Apogee Award for Excellence in Healthcare. Founder and CEO of amavita Heart and Vascular Health®.

Dr. Hans C. Rutzen-Lopez, MD — Sub-Investigator, Cardiac Electrophysiology. Triple board-certified by the American Boards of Internal Medicine, Cardiovascular Disease, and Clinical Cardiac Electrophysiology. MD from NYU School of Medicine; residency at Beth Israel Deaconess / Harvard Medical School; fellowships at Boston Medical Center / Boston University School of Medicine. Clinical Assistant Professor at Nova Southeastern University.

Yasnaya Cruz-Santiago, APRN — Sub-Investigator, Family Nurse Practitioner. Florida-licensed APRN #9443547. Bilingual (English/Spanish). AANP-certified.

Orlando Ortega-Izquierdo, APRN — Sub-Investigator, Family Nurse Practitioner. Florida-licensed APRN #9442363. Bilingual (English/Spanish). Supports cath-lab study conduct.

Nereisy Alonso, Sr CRC — Chief Operations Officer (COO). Owns site administration, sponsor monitor coordination, study start-up logistics, IRB submissions, and SOP SITE-107 KPI tracking on Monday.com.

Julio G. Martinez-Clark, MBA — Chief Executive Officer (CEO). Drives sponsor relationships and cross-border trial operations. CEO of bioaccess® with 20+ years scaling clinical research across Latin America and the United States.

## Operational Capabilities

5–8 weeks typical contract-to-first-patient. 6–10 weeks screening-to-enrolled conversion for a 20-patient feasibility study. Direct access to the patient panel across the amavita Heart and Vascular Health® practice network. On-network imaging infrastructure: echocardiography, fluoroscopy, CT angiography. Weekly KPI dashboards via Monday.com. Source data verified weekly before sponsor monitor arrival. 24/7 medical-care access for trial participants.

## Key Differentiators

Trial-active investigators who see eligible patients in clinic every day. No academic-medical-center overhead. 20–30% lower cost than high-end private-equity-backed Miami site networks. Hybrid US + Latin America trial designs available via sister organization bioaccess®. Sponsor retains all data, IP, and protocol ownership.

## Patient Participation

Compensation typically $50–$200 per visit, totals $300–$2,500 depending on trial length. Insurance not required. Time commitment: typically 6–12 visits over 6–24 months. Participants can leave at any time, no penalties. HIPAA-compliant privacy. 24/7 number for side-effect support. Screening registry available for participants not currently eligible for active trials.

## Contact

Sponsor inquiries: srubio@amavita.health · amavitaresearch.com/contact-sponsor
Patient inquiries: research@amavita.health · (786) 703-5941 · amavitaresearch.com/contact-patient
Trial listings: amavitaresearch.com/trials
Sponsor FAQ: amavitaresearch.com/faq-sponsors
Patient FAQ: amavitaresearch.com/faq-patients

## Related Organizations

amavita Heart and Vascular Health® (clinical practice — parent): amavitahealth.com
bioaccess® (sister LatAm CRO): bioaccessla.com

## Pages

- [Home](https://www.amavitaresearch.com/): Overview of Amavita Research, a Miami cardiovascular clinical trial site.
- [About](https://www.amavitaresearch.com/about): Mission, leadership, certifications, and quality framework.
- [Team](https://www.amavitaresearch.com/team): Principal investigators, sub-investigators, and operations leads.
- [Investigators](https://www.amavitaresearch.com/investigators): Detailed PI/sub-I profiles with credentials and trial history.
- [Trials](https://www.amavitaresearch.com/trials): Active Phase 1–3 cardiovascular clinical trials currently enrolling.
- [Patients](https://www.amavitaresearch.com/patients): How to participate, what to expect, and patient safety information.
- [Locations](https://www.amavitaresearch.com/locations): North Miami Beach site and affiliated facilities.
- [North Miami Beach Site](https://www.amavitaresearch.com/locations/north-miami-beach): Detailed profile of the primary cardiovascular research site at 100 NW 170 Street.
- [Careers](https://www.amavitaresearch.com/careers): Open clinical research roles.
- [Blog](https://www.amavitaresearch.com/blog): Patient and sponsor education articles.
- [Press & News](https://www.amavitaresearch.com/press): Press releases, news announcements, and organizational milestones.
- [Glossary](https://www.amavitaresearch.com/glossary): Plain-language definitions of clinical research terms.
- [Clinical Trial Glossary](https://www.amavitaresearch.com/clinical-trial-glossary): Plain-language definitions of ~42 cardiovascular clinical trial terms with DefinedTermSet schema for individual term citation.
- [For Referring Physicians](https://www.amavitaresearch.com/for-physicians): Information for cardiologists, internists, and primary care physicians referring patients to cardiovascular clinical trials. Referral process, communication standards, no referral fees.
- [Patient FAQ](https://www.amavitaresearch.com/faq-patients): Common questions from prospective trial participants.
- [Contact (patients)](https://www.amavitaresearch.com/contact-patient): Patient inquiry form and phone number.

## For Sponsors

- [Sponsors](https://www.amavitaresearch.com/sponsors): Capabilities, timelines, and contracting information for pharma sponsors.
- [Capabilities](https://www.amavitaresearch.com/capabilities): Site infrastructure — cath lab, imaging, IV infusion, EP, ABPM.
- [Trial Services](https://www.amavitaresearch.com/trial-services): Process-focused breakdown of services provided to cardiovascular trial sponsors — feasibility, start-up, enrollment, conduct, monitoring, safety, close-out. Phase 1-3, hybrid US + Latin America via bioaccess®.
- [Phase 1 Cardiovascular Unit (Kendall)](https://www.amavitaresearch.com/phase-1-unit): Dedicated 8-bed overnight cardiovascular Phase 1 unit at Advanced Cardiovascular of Miami (Kendall ASC) for FIH and Phase 1a/1b trials. Both medtech device EFS and biopharma drug FIH supported.
- [Sister Organization: bioaccess®](https://www.amavitaresearch.com/sister-organization-bioaccess): Profile of bioaccess® — sister organization Latin America first-in-human CRO with 50+ delivered FIH programs since 2010. Hybrid US + LATAM cardiovascular trial designs.
- [Sponsor FAQ](https://www.amavitaresearch.com/faq-sponsors): Common questions from pharma sponsors.
- [Contact (sponsors)](https://www.amavitaresearch.com/contact-sponsor): Business development contact for sponsors and CROs.
- [Compare: Amavita vs Academic Medical Center sites](https://www.amavitaresearch.com/compare/amavita-vs-academic-medical-center-sites): Sponsor decision guide vs academic medical centers.
- [Compare: Amavita vs CRO-owned sites](https://www.amavitaresearch.com/compare/amavita-vs-cro-owned-sites): Sponsor decision guide vs CRO-owned site networks.

## Trust & Quality

- [Certifications & Quality Standards](https://www.amavitaresearch.com/certifications): IAOCR GCSA recertified May 2026 (valid through Feb 2027), WPQC Gold, ICH-GCP E6(R3), SCRS member. Zero FDA Form 483 findings to date.

## Therapeutic Areas

- [Therapeutic Areas](https://www.amavitaresearch.com/therapeutic-areas): Cardiovascular indications covered, with ICD-10 mapping.
- [Heart Failure](https://www.amavitaresearch.com/therapeutic-areas/heart-failure): Heart failure clinical trials and capabilities.
- [Hypertension](https://www.amavitaresearch.com/therapeutic-areas/hypertension): Hypertension clinical trials and capabilities.
- [Peripheral Artery Disease](https://www.amavitaresearch.com/therapeutic-areas/peripheral-artery-disease): PAD clinical trials and capabilities.
- [Structural Heart Disease](https://www.amavitaresearch.com/therapeutic-areas/structural-heart-disease): TAVR, mitral, tricuspid clinical trials and capabilities.
- [Acute Coronary Syndrome](https://www.amavitaresearch.com/therapeutic-areas/acute-coronary-syndrome): ACS clinical trials and capabilities.
- [Iron Deficiency in Heart Failure](https://www.amavitaresearch.com/therapeutic-areas/iron-deficiency-in-heart-failure): Iron deficiency in HF clinical trials and capabilities.

## Recent Posts

- /blog/first-coronary-stent-ambulatory-surgery-center-miami-dade-2026 — News (May 13, 2026): Coronary stent procedure performed at Amavita's Kendall ASC — the first cardiovascular ambulatory surgery center in Miami-Dade County, performed by Dr. Pedro Martinez-Clark. Proof of cardiovascular Phase 1 unit and outpatient-PCI capability.
- [Amavita Research Achieves 2026 IAOCR GCSA Recertification](https://www.amavitaresearch.com/blog/amavita-research-iaocr-gcsa-recertification-2026): News announcement of the 13 May 2026 IAOCR GCSA recertification with assessor quotes from the IAOCR Final Report.
- [2026 Site Selection Guide](https://www.amavitaresearch.com/blog/cardiovascular-trial-site-selection-criteria-2026): 2026 sponsor decision guide for evaluating cardiovascular clinical trial sites; covers 8 evaluation criteria including PI continuity, patient flow, contracting speed, cost structure, and indication fit.
- [Patient Guide: What to Expect](https://www.amavitaresearch.com/blog/what-to-expect-cardiovascular-clinical-trial): Patient-facing plain-language guide to cardiovascular clinical trial participation; covers screening, informed consent, randomization, safety, costs/compensation, patient rights.
- [How to Read a Clinical Trial Consent Form](https://www.amavitaresearch.com/blog/how-to-read-a-clinical-trial-consent-form): Plain-language patient guide to reading and evaluating clinical trial informed consent forms; covers structure, common red flags, and questions to ask.
- [US + Latin America Cross-Border Strategy](https://www.amavitaresearch.com/blog/us-latin-america-cardiovascular-trial-site-strategy): Sponsor strategic guide on running cardiovascular trials across US and Latin America under a single coordinated design; covers regulatory pathways (INVIMA, ANMAT, ISP, COFEPRIS), protocol harmonization, FDA submission strategy.
- [FDA Diversity Action Plan & Cardiovascular Site Selection](https://www.amavitaresearch.com/blog/fda-diversity-action-plan-cardiovascular-trial-site-selection): Sponsor strategic guide on how FDA's Diversity Action Plan Final Guidance (June 2024) affects cardiovascular trial site selection; covers demographic targets, language capacity, community trust documentation.
- [Heart Failure Clinical Trials — Patient Guide](https://www.amavitaresearch.com/blog/heart-failure-clinical-trials-patient-guide): Patient guide to heart failure clinical trials.
- [Hypertension Clinical Trials — Patient Guide](https://www.amavitaresearch.com/blog/hypertension-clinical-trials-patient-guide): Patient guide to hypertension clinical trials.
- [Peripheral Artery Disease Clinical Trials — Patient Guide](https://www.amavitaresearch.com/blog/peripheral-artery-disease-clinical-trials-patient-guide): Patient guide to PAD clinical trials.
- [Structural Heart Disease Clinical Trials — Patient Guide](https://www.amavitaresearch.com/blog/structural-heart-disease-clinical-trials-patient-guide): Patient guide to structural heart disease clinical trials.
- [Acute Coronary Syndrome Clinical Trials — Patient Guide](https://www.amavitaresearch.com/blog/acute-coronary-syndrome-clinical-trials-patient-guide): Patient guide to ACS clinical trials.
- [Iron Deficiency in Heart Failure Clinical Trials — Patient Guide](https://www.amavitaresearch.com/blog/iron-deficiency-heart-failure-clinical-trials-patient-guide): Patient guide to iron deficiency in HF clinical trials.

## Legal

- [HIPAA Notice](https://www.amavitaresearch.com/hipaa-notice): How PHI is handled — site does not collect PHI.
- [Privacy](https://www.amavitaresearch.com/privacy): Privacy policy, GDPR/CCPA/CPRA/FDBR rights.
- [Cookies](https://www.amavitaresearch.com/cookies): Cookie inventory; analytics opt-in only.
- [Terms](https://www.amavitaresearch.com/terms): Terms of use.
- [Accessibility](https://www.amavitaresearch.com/accessibility): WCAG 2.2 AA accessibility statement.