---
title: "Trial Services for Sponsors — Feasibility, Phase I–IV, Devices, Drugs, Hybrid US+LATAM | Amavita Research"
url: https://md.amavitaresearch.com/trial-services
canonical: https://www.amavitaresearch.com/trial-services
schema_type: Service
last_updated: 2026-05-13
---

# Trial Services for Sponsors

Amavita Research offers a full catalog of cardiovascular trial services to medtech and biopharma sponsors, executed from a single Miami site with on-site procedural infrastructure and a single named Principal Investigator per protocol.

## Service catalog

- **Feasibility studies** — Pre-pivotal feasibility cohorts (typically 5–20 patients), rapid screening-to-enrolled conversion using walk-in cardiology patient flow.
- **Pivotal Phase 3 trials** — Currently enrolling Pfizer LIBREXIA-ACS, Alnylam ZENITH-zilebesiran, Pharmacosmos IV ferric derisomaltose, Avantec/CSI GREAT (Golazo® atherectomy).
- **Phase 2 trials** — Salubris JK07 chronic heart failure (NCT06369298), VASA VS-041 HFpEF Phase 1.
- **First-in-human studies** — Site is qualified for early-feasibility cardiovascular device studies; sister organization bioaccess® handles Latin America first-in-human arms.
- **Hybrid US + Latin America designs** — Single coordinated protocol with U.S. arm at Amavita Research and Latin America arm at bioaccess® (Colombia and regional markets).
- **Device trials** — Coronary, structural heart, electrophysiology, peripheral. Triple-board-certified EP on staff for AFib/device protocols.
- **Drug trials** — IV, SC, and oral cardiovascular drug dosing under PI supervision. On-site IV infusion suite.

## Trial design parameters supported

- Single-arm or randomized controlled
- Blinded or open-label
- Adaptive designs (with sponsor statistical input)
- Crossover designs
- Imaging core-lab integration (echo, cath, cardiac CT/MRI)
- Central ECG reading
- Patient-reported outcomes (PRO) collection
- ePRO with sponsor-provided platforms
- Quality of life (KCCQ, SF-36) instruments

## Sponsor decision criteria

- 5–8 weeks contract-to-first-patient for qualified trial types
- 6–10 weeks screening-to-enrolled for typical 20-patient feasibility
- 20–30% lower cost than high-end PE-backed Miami site networks
- Zero FDA Form 483 findings
- Single named PI per protocol — no PI rotation
- Patient flow from in-network cardiology practice — not database recruitment

## Site qualification process

1. Sponsor sends protocol synopsis or full protocol
2. Site reviews indication fit, patient flow alignment, equipment requirements
3. Feasibility questionnaire returned in 5 business days
4. PI conference call with sponsor medical/clinical team
5. Budget and CTA negotiation
6. IRB submission (central preferred)
7. Site initiation visit (SIV)
8. First patient in

## Key links

- Site capabilities: https://www.amavitaresearch.com/capabilities
- Active trials: https://www.amavitaresearch.com/trials
- Principal investigators: https://www.amavitaresearch.com/investigators
- Sponsor FAQ: https://www.amavitaresearch.com/faq-sponsors
- Sponsor contact: https://www.amavitaresearch.com/contact-sponsor
- Comparison vs. CRO-owned/PE-backed networks: https://www.amavitaresearch.com/compare/amavita-vs-cro-owned-sites
- Comparison vs. academic medical centers: https://www.amavitaresearch.com/compare/amavita-vs-academic-medical-center-sites