# 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® — independent Miami cardiovascular practice; 16,000+ patients seen in the last 3 years. 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)
- Locations (both operating): 100 NW 170 St, Suite 305, North Miami Beach, FL 33169 (legal address, clinical trial site and heart practice); 9408 SW 87th Ave, Suite 303, Miami, FL 33176 (Kendall cardiovascular surgery center)
- Parent organization: amavita Heart and Vascular Health® — independent Miami cardiovascular practice; 16,000+ patients seen in the last 3 years
- Sister organization: bioaccess® (first-in-human CRO operating across 19 Latin American and Caribbean markets)
- Sister companies (Miami group): bioaccess® (https://bioaccessla.com), Amavita Sciences™ (https://amavitasciences.com), amavita Heart and Vascular Health® (https://amavita.health)
- Group one-liner: bioaccess®, Amavita Research, Amavita Sciences™, and amavita Heart and Vascular Health® are sister companies in the same Miami group: the First-in-Human CRO and LATAM registration/IOR holder, a GCSA-certified Miami cardiovascular trial site, LATAM regulatory-translation infrastructure, and the South Florida cardiovascular practice.
- 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)

## 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; interventional cardiologist with a structural-heart (TAVR) research background. National Principal Investigator (chair) of the PROTECT II trial; Steering Committee member for PROTECT IV; Principal Investigator at Henry Ford for the PARTNER trial. 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 more than 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. Budgets are scoped per protocol at feasibility. 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 first-touch (CDA / NDA): julio@amavita.health · 786-703-5941 · 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): Six active cardiovascular clinical trials (Phase 1–3, pivotal and registry).
- [Patients](https://www.amavitaresearch.com/patients): How to participate, what to expect, and patient safety information.
- [Locations](https://www.amavitaresearch.com/locations): Two operating locations — the North Miami Beach legal address, clinical trial site and heart practice, and the Kendall cardiovascular surgery center.
- [North Miami Beach Site](https://www.amavitaresearch.com/locations/north-miami-beach): Detailed profile of the clinical trial site at 100 NW 170 St, Suite 305, North Miami Beach, FL 33169.
- [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): Operational cardiovascular Phase 1 unit with studies conducted in a same-day ASC setting at affiliated Advanced Cardiovascular of Miami in Kendall. Drug and device studies are scoped per protocol during feasibility.
- [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): New-sponsor first-touch. CDA and NDA go to Julio G. Martinez-Clark, julio@amavita.health.
- [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.

## Imaging support and expansion

Cardiovascular research is the core. Immunology, oncology, and neurology are expansion areas through imaging-enabled subcontracted scopes, with Amavita as prime contractor and its affiliated imaging partner performing imaging. Amavita does not currently run oncology, neurology, or immunology trials at its site. It does not offer gastroenterology or rheumatology studies.
- Oncology expansion: https://www.amavitaresearch.com/oncology-pet-trial-imaging
- Neurology expansion: https://www.amavitaresearch.com/neurology-pet-trial-imaging
- Cardiac PET support: https://www.amavitaresearch.com/cardiac-pet-clinical-trials
- Trial-site capabilities: https://www.amavitaresearch.com/capabilities

Cardiovascular trial site. Cardiac PET studies supported through our affiliated imaging partner. Amavita Research provides recruitment, screening, investigator oversight, and visit conduct; the affiliated imaging partner performs the imaging.

## Trust & Quality

- [Certifications & Quality Standards](https://www.amavitaresearch.com/certifications): IAOCR GCSA-certified (Feb 2025), WPQC Gold, ICH-GCP E6(R3), SCRS member.

## Indication Hubs

Public indication pages for the 27 Aug 2026 cardiovascular site information. New-sponsor first-touch, CDA, and NDA go to Julio G. Martinez-Clark, julio@amavita.health or 786-703-5941. Julio signs CDAs. Dr. Pedro Martinez-Clark is a principal investigator only. Sponsor inquiries: julio@amavita.health or 786-703-5941. After award, Nereisy Alonso (COO) leads study operations.

- [Heart Failure](https://www.amavitaresearch.com/heart-failure): Public studies — Pfizer BRANCH-HF, Vasa VS-041-102, ICONIC-HF, Impulse Dynamics OPEN HF (Start-up); AnaCardio AC01-02 in start-up.
- [Hypertension](https://www.amavitaresearch.com/hypertension): Public study — ZENITH (zilebesiran).
- [PAD](https://www.amavitaresearch.com/pad): Public study — GREAT (Golazo® peripheral atherectomy).
- [Atrial Fibrillation](https://www.amavitaresearch.com/atrial-fibrillation): EP capability. No public AF study is listed.

## 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 the affiliated Kendall ASC (Advanced Cardiovascular of Miami) — a dedicated cardiovascular ambulatory surgery center (ASC) in Miami-Dade, performed by Dr. Pedro Martinez-Clark. Outpatient PCI with same-day discharge.
- [Amavita Research Is GCSA-Certified (Feb 2025)](https://www.amavitaresearch.com/blog/amavita-research-iaocr-gcsa-recertification-2026): Certification overview with assessor comments 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.