For Sponsors and CROs
Trial Services
What Amavita Research delivers, end-to-end, for cardiovascular trial sponsors.
This page is for sponsor clinical-operations leads and CRO site-identification managers evaluating whether Amavita Research fits a specific protocol. It covers what we do at each stage of a trial — feasibility, contracting, start-up, enrollment, conduct, monitoring, safety reporting, and close-out — and which trial phases and indications are within our scope. For infrastructure-level details (cath-lab, ECG, imaging, etc.), see /capabilities. For decision-criteria framework, see /blog/cardiovascular-trial-site-selection-criteria-2026.
New: See our Phase 1 unit — dedicated 8-bed overnight cardiovascular FIH unit at the Kendall ASC →
Trial phases we support
| Phase | Support level | Typical use |
|---|---|---|
| Phase 1 (FIH) | Supported via bioaccess® LATAM arm for U.S.-LATAM hybrid designs; Phase 1 conduct at the U.S. site limited to specific indications | First-in-human cardiovascular studies |
| Phase 2 | Full support, single-site or multi-site | Dose-finding, early efficacy, signal-seeking trials |
| Phase 3 (pivotal) | Full support, single-site or multi-site, including DAP-compliant enrollment | Pivotal trials supporting NDA/BLA/PMA submissions |
| Phase 4 / post-marketing | Selective support, depends on protocol fit | Long-term safety registries, real-world evidence studies |
| Device feasibility & pivotal | Full support; cath-lab and procedural infrastructure on-site | Cardiovascular device trials including atherectomy, PCI, structural heart |
Services we provide at each stage
Feasibility (pre-CDA)
- Initial fit-check from protocol synopsis or key inclusion/exclusion criteria
- Indicative timeline for CDA-to-FPE
- Indicative budget range
- Sample-size feasibility based on indication-specific patient flow at the site
- Demographic profile assessment for DAP planning
Contracting and start-up (CDA-to-FPE)
- CDA execution within 3-5 business days for protocols within qualified scope
- CTA negotiation with standard sponsor templates
- IRB strategy (central preferred — WCG, Advarra; local IRB available if sponsor requires)
- Site qualification questionnaire response
- Investigator meeting attendance (in-person or virtual)
- IP receipt, accountability setup, temperature-monitored storage
- Source-document and eCRF preparation
- Training on protocol-specific procedures
Enrollment
- Patient identification via walk-in clinical flow from the active cardiology practice
- Pre-screening by the PI (also the patient's cardiologist for routine care)
- Informed consent in English, Spanish, Haitian Creole, and Brazilian Portuguese
- Screen-fail reporting
- Randomization per protocol
- DAP-aligned demographic capture
Trial conduct
- Visit conduct per protocol
- IP administration (pill, SC injection, IV infusion, in-office procedure)
- Symptom diary and patient-reported outcomes capture
- Adverse event identification, grading, and reporting
- Concomitant medication tracking
- Protocol deviation documentation
- Sponsor monitoring (on-site or remote)
Monitoring support
- Dedicated CRC workspace with secure network access
- Source-document access to monitors per ICH-GCP
- Query response within sponsor's SLA
- Pre-monitoring visit preparation
- Close-out visit support
Safety reporting
- Serious adverse event reporting per protocol
- IND safety reporting timelines met
- IRB safety reporting
- Sponsor pharmacovigilance integration
- DSMB cooperation for trials with active boards
Trial close-out
- Final patient visits and follow-up data capture
- IP return or destruction per sponsor instructions
- Source-document archival per ICH-GCP retention requirements
- Final monitoring visit
- Sponsor close-out reports
- Patient hand-back to routine cardiology care
Indications within our qualified scope
- Hypertension (including resistant hypertension)
- Heart failure (HFrEF, HFpEF, HFmrEF)
- Acute coronary syndrome
- Peripheral artery disease (including below-the-knee)
- Iron deficiency in heart failure
- Structural heart disease (consultative leadership; limited procedural scope at the U.S. site)
- Atrial fibrillation and other arrhythmias (via EP capability)
For indications outside this list, we can usually evaluate fit on a per-protocol basis.
What we don't do
- Oncology trials (cardiovascular site, not oncology)
- Pediatric cardiology (adult-population site)
- Advanced heart failure transplant or LVAD trials (requires transplant-center infrastructure)
- Trials requiring specific imaging core lab facilities not housed at affiliated centers
- Trials where geographic breadth across many U.S. sites is the primary value (we're a single high-quality site, not a network)
If your protocol is outside this scope, we'll say so quickly and (where appropriate) suggest other resources.
Hybrid US + Latin America designs
For protocols where a Latin America arm makes strategic sense (covered in our /blog/us-latin-america-cardiovascular-trial-site-strategy guide), Amavita Research and bioaccess® operate as a single coordinated team. bioaccess® is a Latin America first-in-human CRO with operations in Colombia, Argentina, and other regional markets. The two organizations share leadership and operational infrastructure, which means sponsors get a single coordinated contract path, a single data flow, and consistent quality framework across both regional arms.
Pricing and budget transparency
Our budget structure is transparent: per-patient costs, study coordinator time, procedural costs, and a single site overhead allocation (lower than typical PE-backed Miami site networks by 20-30%). We do not carry an MSO or academic indirect-cost layer. Budget ranges by indication and phase are available on request — typically we share these in the feasibility-questionnaire response.