Cardiovascular first, imaging-enabled next: how Amavita Research plans to act as prime site on multimodal protocols

Sponsors sometimes ask us a fair question: "You are a cardiovascular site. Why are you talking about immunology, oncology and neurology?" The short answer is that we are not running those trials today, and I do not want anyone to read our site and think otherwise. The longer answer is that modern protocols increasingly depend on imaging, and imaging creates a way for a focused site to take on more complex work responsibly, as the prime site with qualified partners performing defined scopes.

I'm Julio Martinez-Clark, CEO of Amavita Research. This article explains where we are, where we plan to go, and how the prime-site model works, so a sponsor can judge whether it fits a future protocol. It is written to be clear about the line between what we do now and what we are building.

Why protocols are becoming multimodal

Across therapeutic areas, imaging has moved from a supporting assessment to a primary or key secondary endpoint in many trials. Cardiac MRI and echocardiography track remodeling in heart failure. CT angiography characterizes plaque and anatomy before an intervention. In oncology, neurology and immunology, imaging is often how disease activity, response or progression is measured, read centrally by an independent core lab under an imaging charter.

The consequence for sites is practical. A protocol may need a site that can recruit and manage the participant, administer the investigational product, collect safety data and also deliver imaging acquisitions on a fixed schedule, to a core-lab standard, every time. Very few small sites own every modality. The question is how the site coordinates the parts it does not own.

Our core: cardiovascular

Cardiovascular research is what Amavita Research does today, and it will stay the center of the site. Our investigators are practicing cardiologists in amavita Heart and Vascular Health®, an independent Miami cardiovascular practice. Current capability covers:

• Interventional cardiology, including coronary and peripheral work, with access to the cath lab and procedure suites at our affiliated ambulatory surgery center, Advanced Cardiovascular of Miami in Kendall.
• Structural heart consultative leadership on high-acuity structural protocols.
• Cardiac electrophysiology through a board-certified electrophysiologist on the investigator team.
• Heart failure, hypertension, acute coronary syndrome and peripheral artery disease protocols across drug and device sponsors.
• Cardiovascular imaging that most cardiovascular protocols need, including transthoracic echocardiography on site, with transmission to sponsor core labs.
• A cardiovascular Phase 1 unit with 8 monitored observation beds with continuous ECG telemetry inside the affiliated ASC, run as a same-day outpatient setup.

You can see the full list on our capabilities page and the indications on our therapeutic areas page.

Where we are going, and what is not true yet

Our plan, set by our leadership team, has three parts:

1. Own cardiovascular. Keep building depth in the indications and procedures we already run.
2. Add immunology. This is the next therapeutic area we intend to build.
3. Pursue oncology and neurology selectively, specifically where a protocol's imaging requirements create a defined scope that a qualified imaging facility can perform under subcontract, with Amavita Research as the prime site.

To be explicit about today:

• We do not currently run oncology, neurology or immunology trials at our site.
• We do not offer gastroenterology or rheumatology studies.
• We have not announced named imaging partners for these expansion areas, and this article should not be read as a claim that any are in place.

I would rather a sponsor hear "not yet" from us now than discover it in a feasibility questionnaire.

How the prime-site model works

"Prime" is a contracting and accountability idea, not a marketing one. When Amavita Research acts as the prime site, the sponsor contracts with us, and we bring in a qualified subcontractor for a defined scope, such as an imaging modality we do not own. Here is how responsibilities divide.

What stays with Amavita Research

• The sponsor relationship and the contract. One clinical trial agreement and budget, with the subcontracted scope priced and described inside it.
• Investigator oversight. Under ICH E6(R3), the investigator remains responsible for trial-related activities delegated to other parties. The principal investigator supervises the subcontracted work through the delegation log and the site's procedures.
• Regulatory documents. IRB submissions, essential documents and, for US IND studies, the investigator's Form FDA 1572, which identifies the facilities where study activities are performed.
• Participant management. Recruitment, consent, dosing or procedures, safety reporting, visit scheduling and source documentation.
• Single point of contact. Monitors and the sponsor's study team deal with one site team, not two.

What a subcontracted imaging facility would do

• Perform the specified acquisitions to the protocol's imaging manual or charter, on the visit schedule.
• Hold the equipment qualifications and phantom or test scans the core lab requires.
• Transfer images to the sponsor's core lab in the specified format and timeline.
• Maintain its own licenses, accreditation and quality records, available for monitoring and audit.

What makes it work, or fail

Prime-site arrangements fail when the handoffs are vague. The controls we plan around are simple: a written subcontract that flows down the sponsor's confidentiality, data and audit terms; a named imaging contact; a visit-level scheduling process that books imaging inside the protocol window before the participant is dosed; a reconciliation of every acquisition against the core lab's receipt log; and a clear rule for who reports what when an incidental finding appears. None of these is unusual. They just have to be written down before the first participant, not after the first missed window.

Transparent operational scope

Whatever the therapeutic area, our setting determines what we can run. Amavita Research is a daytime outpatient research site. Our Phase 1 unit is same-day, designed to fit within ambulatory surgery center admit-and-discharge rules. Protocols that require overnight or multi-day residential confinement, or in-unit critical care, are not a fit for this setting, and we will say so at feasibility.

For expansion-area protocols, the same rule applies, with one more filter: we will only take on a non-cardiovascular protocol when the investigator coverage, the imaging scope and the subcontract are in place and documented. If any of those is missing, the right answer is "not this study."

Why a cardiovascular site is a sensible prime

Cardiovascular sites already live with the operational demands that imaging-heavy protocols bring: tight procedure scheduling, core-lab transmissions, strict acquisition protocols and close safety monitoring. Some oncology, neurology and immunology therapies also carry cardiovascular safety monitoring requirements, such as ECG and cardiac function assessments. A site that does those well is a reasonable place to coordinate a multimodal protocol, provided the therapeutic-area expertise and the imaging scope are genuinely in place.

Amavita Research is also part of the same research group as bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. Sponsors who need a US site alongside Latin American work can plan both through one group.

What this means for sponsors today

• Cardiovascular protocols: talk to us now. That is our core, and you can review our sponsor information and trial listings.
• Immunology, oncology or neurology protocols with a strong imaging component: talk to us early, as a planning conversation, not a feasibility commitment. We will tell you honestly whether and when we could act as prime.
• Gastroenterology or rheumatology protocols: we are not the right site.

The fastest way to start is a short synopsis through our sponsor contact form. Tell us the indication, phase, imaging requirements and visit schedule, and we will give you a straight answer.

Julio Martinez-Clark, CEO, Amavita Research. Forward-looking statements describe plans, not current capabilities. Therapeutic-area coverage is confirmed per protocol during feasibility.