A good EFS site brings prior EFS or first-in-human experience, an IRB sophisticated with early-phase work, contracting speed, investigator and team procedure expertise, a real referral network, ICU and surgical backup, and monitoring-ready research infrastructure. The process runs criteria, long list, feasibility, qualification. The ecosystem includes the MDIC Clinical Site Alliance and EFS Explorer, the MDIC + Veranex site-selection tool announced September 2026. Honest framing: bioaccess has no US hospital site network — it advises on site selection and EFS strategy from Miami; proven execution is across 19 Latin American and Caribbean countries.
Figures attributed; general information, not regulatory advice.
Seven criteria: prior EFS or first-in-human experience; IRB sophistication with early-phase work; contracting speed; investigator and team expertise with the procedure; referral network and patient access; ICU and surgical backup matched to the device's risk profile; and research infrastructure with monitoring readiness. Early-phase data must be validatable — infrastructure is what makes that true.
Four stages: (1) set the criteria — write requirements before looking at sites; (2) build the long list from experience, reputation, networks, and industry resources; (3) run honest feasibility — enrollment, contracting timeline, IRB experience, competing studies; feasibility that flatters is worse than none; (4) qualify the short list on evidence, not enthusiasm.
The Medical Device Innovation Consortium — the non-vendor authority on EFS — convenes a Clinical Site Alliance uniting experienced EFS sites (source: MDIC). In September 2026, Veranex and MDIC announced EFS Explorer, a site-selection tool developed in collaboration to streamline early feasibility study site selection (source: Veranex news, Sep 14, 2026). Both are industry developments, not endorsements.
bioaccess has no US hospital site network. On the US side it advises: FDA strategy and Pre-Sub/EFS-IDE planning from Miami, including site-selection guidance. Its affiliated site, Amavita Research in Miami, participates in cardiovascular studies when the device and study fit. Proven execution is first-in-human and early feasibility studies across 19 Latin American and Caribbean countries, with 50+ pre-qualified sites per the site's published figure.
Choose US sites when early, iterative FDA interaction and US investigator experience are the priority. Choose Latin America when activation speed and enrollment throughput are the binding constraints — with data engineered from day one to come home under 21 CFR 812.28. See US vs Latin America first-in-human.
Prior EFS/FIH experience, early-phase IRB sophistication, contracting speed, procedure expertise, referral network and patient access, ICU/surgical backup, and monitoring-ready infrastructure. Criteria-first selection beats relationship-first.
Small — often one to three, sized to the clinical questions. Each additional site multiplies contracting, training, monitoring, and data management. Add sites for enrollment or procedural diversity, not optics.
It can, but risk concentrates where EFS studies slow: first-time IRBs, first-time research offices, teams without early-phase habits. Compensate explicitly — experienced monitors, tight training, realistic contracting timelines.
MDIC's collaborative network uniting experienced EFS sites — part of its broader EFS program work. A non-vendor industry development, not a bioaccess network or endorsement. See MDIC's EFS page.
A site-selection tool for early feasibility studies announced by Veranex and MDIC in September 2026 — the industry's first purpose-built tooling for this decision. An industry development, not a bioaccess product or endorsement.
Depends on the program: US sites for early iterative FDA interaction; LATAM sites for activation speed and enrollment. bioaccess has no US hospital site network — it advises from Miami; Amavita Research Miami fits cardiovascular studies; proven execution spans 19 Latin American and Caribbean countries.
Related: FDA EFS program · US vs Latin America · EFS IDE · EFS in Latin America · US EFS support