Figures cited from a ClinicalTrials.gov API v2 facility pull (25 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Colombia’s National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Hospital San Vicente Fundación Medellín as a bioaccess® client.
If you searched Hospital San Vicente Fundacion Medellin first-in-human, Hospital Universitario San Vicente Fundacion clinical trial, San Vicente Fundacion Medellin device study, or “go direct Hospital San Vicente Fundación Medellín,” you followed a campus string ClinicalTrials.gov still publishes. Hospital San Vicente Fundación in Medellín, Colombia (also registered as Hospital Universitario San Vicente Fundación), is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the INVIMA file.
bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns INVIMA, accredited ethics, investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named Medellín Hospital San Vicente Fundación campus. It is DISTINCT from the Universidad de Antioquia Medellín page (CMS 95781), from the San Vicente Fundación site listed in Rionegro (a different city, not counted here), from Centro Médico Privado San Vicente Diabetes in Córdoba, Argentina (CMS 95858), and from Hospital São Vicente de Paulo in Passo Fundo, Brazil. Sharing Medellín or the name San Vicente is not a license to collapse them.
Why the campus name wins the search — and why that is not a CRO
Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 25 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:
Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 25 September 2026 for the facility strings listed below, restricted to locations in Medellín, Colombia. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not union separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- Hospital San Vicente Fundación (Medellín, Colombia) — registry strings counted: “Hospital San Vicente Fundación”; “Hospital Universitario San Vicente Fundacion”. ALL studies n=13; interventional n=11; DEVICE n=2. Example NCT IDs: NCT01864590, NCT05510193, NCT03345511.
Cite ALL n=13 and DEVICE n=2. Aliases are counted once per NCT ID for Medellín locations; 2 of the 13 are observational. Example IDs list the 2 DEVICE registrations first, then 1 non-device registration.
Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.
We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.
That is the leak: a founder searching Hospital San Vicente Fundación in Medellín finds ALL n=13 (DEVICE n=2) without finding INVIMA. A named hospital campus is still a site. An NCT location row is not a CRO.
The site is the site. The CRO is the operator.
A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.
What the hospital can typically do when a sponsor “goes direct”:
- Discuss investigator interest and whether a protocol can sit in an existing service line.
- Share institutional ethics-committee calendars and hospital research rules.
- Quote visit, staffing, and local procedure costs for the cases they will physically run.
What the hospital is not built to own for an investigational device:
- INVIMA. INVIMA is the national file for an investigational device in Colombia. Resolución 8430/1993 still sits on the ethics and research side of that stack. A hallway conversation on this campus is not the INVIMA dossier. Resolución 2378 does not govern device clinical trials — see the live country pages rather than importing a drug good clinical practice (GCP) resolution onto a device file. A hallway conversation at Hospital San Vicente Fundación is not a Universidad de Antioquia file and is not an INVIMA file.
- Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
- ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
- The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
- Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.
Going direct to this campus is how you confirm a room. It is not how you open an investigational file.
How INVIMA actually works (the short version)
Use CRO in Colombia. Published comparison already on the Panama country page: Colombia ethics typically 4–6 weeks; per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email in Medellín is not INVIMA clearance.
Ask for a protocol-specific calendar. A hospital email is not INVIMA clearance. bioaccess® manages the file. That is CRO work, not site work.
All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).
Do not smear the hospital
Hospital San Vicente Fundación is a serious named Medellín campus on the public registry. ALL n=13 and DEVICE n=2 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.
What the CRO still does after you have the campus on a slide
- Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
- Protocol, investigator’s brochure (IB), informed consent form (ICF), insurance, and the INVIMA / ethics packet.
- Importer of record and device accountability.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (HDE) — eligibility, not a promise of FDA action.
The firm was founded in 2010. That is the operator layer around a campus string.
Colombia is still on the map
Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
Frequently asked questions
Can I contract Hospital San Vicente Fundación Medellín directly for a device FIH?
You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your INVIMA applicant, importer of record, insurance coordinator, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.
Did bioaccess® run the NCT IDs listed here?
No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as Universidad de Antioquia Medellín?
No. universidad-de-antioquia-medellin-fih (CMS 95781) is a distinct Medellín page already live. This page is Hospital San Vicente Fundación Medellín only.
Did bioaccess® run NCT01864590?
No. We cite it as facility evidence. We will not invent a sponsor or a PI.
Next step
If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Medellín sibling (do not merge): Universidad de Antioquia Medellín.
Julio G. Martinez-Clark, CEO · bioaccess®