Why dedicated cardiovascular research sites outperform hospital systems in Phase I/II enrollment

Early-phase cardiovascular trials do not fail because the protocol is unclear. They stall because procedure days compete with the rest of the hospital. When research shares telemetry beds, cath-lab slots and coordinator time with clinical operations, protocol procedures get deferred. Dedicated cardiovascular research sites reverse that priority: the study owns the bed, the monitor and the schedule.

I'm Julio Martinez-Clark, CEO of Amavita Research Services. We run cardiovascular trials in Miami, including early-phase and first-in-human work through a Phase 1 unit at an affiliated cardiovascular ambulatory surgery center. This article explains why dedicated research sites outperform hospital systems on Phase I/II enrollment speed and protocol fidelity, what infrastructure actually matters, and how we protect early feasibility milestones without promising numbers we cannot keep.

The hospital-system priority problem

Large hospital systems are excellent at complex care. They are not built to treat a five- or ten-subject early feasibility protocol as the day's most important work. Monitored beds serve the whole institution. Cath-lab block time is allocated to clinical volume first. Research coordinators often cover multiple therapeutic areas. Institutional review and contracting run through queues sized for the health system, not for a startup IDE.

None of that is a criticism of hospital investigators. It is a structural fact. When early-phase cardiovascular work sits inside that structure, first-patient-in slips, observation windows get shortened, and protocol deviations cluster around logistics rather than around the device. Sponsors then spend the next monitoring visit explaining why a timed ECG or a same-day imaging window was missed.

Dedicated cardiovascular research sites exist to remove that competition. Research is the primary operation, not a secondary use of clinical capacity.

What a dedicated cardiovascular research site actually looks like

At Amavita Research Services the early-phase unit is built around a specific profile of protocol: catheter-based or transcatheter cardiovascular procedures with a same-day observation window. The infrastructure that matters:

• 8 monitored observation beds with continuous ECG telemetry inside an affiliated, licensed, Medicare-certified, AAAHC-accredited cardiovascular ambulatory surgery center in Kendall, Miami.
• Cath lab and procedure suite access under the same roof, so procedure and observation are not split across campuses.
• Dedicated research coordinators whose primary job is the study schedule, source documentation and monitor readiness — not a mix of clinical floor duties.
• Integrated diagnostics for the assessments early cardiovascular protocols typically require, with quality systems already in place for monitors to audit.
• Investigator coverage across the relevant subspecialties — interventional cardiology, structural heart consultative input and electrophysiology — so feasibility is not waiting on a borrowed service line.

We describe the unit in more detail in our Phase 1 unit overview and in how we apply it to early feasibility device protocols. The point for enrollment: when telemetry and procedure access are reserved for research, screening-to-procedure intervals shrink because the limiting resource is no longer someone else's admission.

Enrollment speed is a scheduling problem first

Phase I and early Phase II cardiovascular enrollment is rarely limited by the size of the patient universe in Miami. It is limited by how fast a qualified subject can be screened, consented, scheduled into a procedure slot and observed under the protocol. Dedicated sites win on three clocks:

1. Procedure-slot clock. Investigational cases are planned as research work, not squeezed between clinical add-ons. Slots can be held with less risk of last-minute clinical displacement.
2. Observation-bed clock. Continuous ECG telemetry beds that exist for the study mean the post-procedure window in the protocol is executable as written. Sponsors do not discover on procedure day that only four hours of monitoring are available when the protocol called for eight.
3. Coordinator clock. A coordinator who owns one or a small number of cardiovascular studies can chase screening labs, imaging and consent revisions the same day. A shared hospital coordinator carrying twenty studies cannot.

Faster first-patient-in is the visible result. Lower protocol-deviation rates on timed assessments are the quieter one, and they matter just as much when FDA or a notified body later reads the early feasibility package.

Startup without the institutional backlog

Hospital systems add startup steps that dedicated research sites can often avoid or compress:

• IRB path. We prefer a central IRB (our team has worked with WCG and Advarra). A local IRB is available if the sponsor requires one. Using the sponsor's single IRB of record avoids a second institutional layer.
• Contract and budget. Negotiation with a focused research site is a direct conversation. Health-system contracting offices optimized for system-wide agreements move on a different calendar.
• Parallel workstreams. Contract, budget, IRB submission, staff training, device storage and procedure-day planning run in parallel under a named coordinator instead of in a fixed institutional sequence.
• Quality systems already standing. Amavita Research Services is IAOCR GCSA-certified and works to ICH-GCP E6(R3). Monitors arrive to existing SOPs.

I will not publish a universal "days to SIV" number. Startup time still depends on the protocol, the IDE status, the IRB and the contract. What I will say is that removing institutional queue time is the part of startup a site controls, and dedicated research sites control more of it.

Protecting early cardiovascular feasibility milestones

Early feasibility and Phase I cardiovascular work is milestone-sensitive. A missed first-patient-in date can push financing, a partner option or a follow-on IDE amendment. Dedicated sites protect those milestones by making the operational risks visible during feasibility, not after site initiation:

• Confirm the observation window, monitoring intervals and sampling schedule against same-day ASC rules before the protocol is finalized.
• Define the hospital-transfer escalation pathway in writing if a subject needs a higher level of care.
• Plan device accountability for small lots and design revisions between subjects, which FDA's 2013 early feasibility IDE guidance anticipates.
• Staff procedure days with the investigators who will actually scrub, not with a rotating service.

When a protocol needs overnight confinement, open surgery or intensive care beyond an ASC setting, we say so during feasibility. That honesty is part of protecting the milestone: the wrong site is worse than a delayed start at the right one. Site-level detail lives on our capabilities page; investigator backgrounds are on the investigators page.

Sponsors comparing site models should also ask who owns the source data on procedure day. At a dedicated research site the telemetry strip, timed vital signs and procedure notes are captured by a team whose primary accountability is the protocol. That sounds administrative. It is how early safety signals stay auditable when the dataset is still small enough that every subject counts.

When a hospital system is still the right answer

Dedicated research sites are not a universal replacement for hospitals. Protocols that need multi-day inpatient monitoring, advanced imaging only available in a tertiary center, or surgical backup that an ASC cannot provide belong in a hospital. The decision rule is simple: match the acuity and the observation window to the setting. For same-day catheter-based early feasibility and Phase I cardiovascular work, the dedicated model usually wins on enrollment velocity and deviation control. For everything else, choose the setting that can actually execute the protocol.

Bring the synopsis

If you are placing a Phase I or early Phase II cardiovascular study and want to test it against a dedicated Miami research site with continuous ECG telemetry and cath-lab access, send the procedure description, observation window, monitoring schedule and inclusion outline. We will map it to the unit and tell you plainly whether it fits. Partner with Amavita Research Services through the capabilities page.