Sponsor FAQ

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.

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; helped develop the Trans-Caval TAVR approach. Dr. Hans C. Rutzen-Lopez, MD — Sub-Investigator, Cardiac Electrophysiology. Triple board-certified (Internal Medicine, Cardiovascular Disease, Clinical Cardiac Electrophysiology).

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 (echo, CT angio, fluoroscopy) are supported through the in-network imaging infrastructure of amavita Heart and Vascular Health®.

For trial types Amavita is already qualified at (most cardiovascular study designs), typical contract-to-first-patient is 5–8 weeks. Add 2–3 weeks if the protocol requires net-new IRB submission. Patient screening starts the moment IRB approves — investigators screen candidate patients against active inclusion criteria during standard clinic visits.

Trial-specific, but Amavita Research has direct access to the patient panel across amavita Heart and Vascular Health® — the largest independent cardiovascular practice in South Florida. For a typical 20-patient cardiovascular feasibility study, screening-to-enrolled conversion is 6–10 weeks. Sponsor receives weekly KPI dashboards via Monday.com showing screened, consented, and enrolled counts against target.

Trial-active. Every PI at Amavita Research carries an active patient panel at amavita Heart and Vascular Health® clinics. Patients seen at clinic visits are screened against active trial inclusion criteria the same week. No 'rent-a-PI' arrangements, no investigator who hasn't run a cardiovascular trial in the last 24 months.

IAOCR GCSA recertified May 2026 (Global Clinical Site Assessment standard, valid through 28 February 2027). IAOCR WPQC Gold for workforce. ICH-GCP E6(R3) compliant SOPs across the full study lifecycle. Society for Clinical Research Sites (SCRS) member. SOP SITE-107 (KPI tracking and audit trail) enforced on every active study. See /certifications for full assessment scope and modules met.

Designated CRC ownership per protocol, Monday.com-tracked KPIs for visit-window adherence, dedicated office space and badge access for sponsor monitor visits, prep packets shipped to monitors before each visit. Source data is verified weekly internally before sponsor monitor arrival, with deviation reports generated automatically.

Zero FDA inspection findings. Sponsor audit history is available on request under MNDA — every sponsor audit since site opening has closed with zero major findings. Detailed audit summaries provided during feasibility for sponsors who require them.

Yes. Amavita Research operates in tight integration 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 Research while bioaccess simultaneously runs a Latin American arm under the same protocol — FDA-ready data on both sides, single sponsor relationship, accelerated total enrollment.

Trial-specific, but typically competitive with academic Miami sites and 20–30% below high-end private-equity-backed site networks. The differential comes from being an independent practice — no academic overhead, no MSO carve-out, no surgical-training program competing for cath-lab time. Detailed budget delivered against the specific protocol during proposal phase.

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; Amavita Research is responsible for site-level execution and source documentation. Site closeout transfers all source records, the trial master file, and electronic data to the sponsor in their preferred format.

Yes. The site has on-network access to the imaging infrastructure of amavita Heart and Vascular Health® — echocardiography, fluoroscopy, CT angiography. Sponsor-specific imaging core labs are accommodated. The site is comfortable with imaging adjudication pipelines including DICOM transfer protocols and de-identification workflows required for blinded core lab review.

Email srubio@amavita.health or use the contact form at amavitaresearch.com/contact-sponsor. The first conversation is typically a 30-minute feasibility call covering indication, inclusion criteria, sample size, and timeline. We respond within one business day. Under MNDA we can share investigator CVs, site qualification packets, and prior-trial enrollment metrics.