Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) 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 INVIMA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital Universitario San Ignacio as a bioaccess® client.
If you searched Hospital Universitario San Ignacio first-in-human, San Ignacio Bogotá clinical trial, HUSI CRO Colombia, or “go direct Hospital Universitario San Ignacio,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Universitario San Ignacio in Bogotá is a real university hospital. It is not a first-in-human medical-device 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, institutional ethics / CEI, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 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 Bogotá San Ignacio campus intercept. It does not clone Fundación Santa Fe de Bogotá. Santa Fe is a different Bogotá building and a different NCT string. Linking is correct. Cloning that page is not.
Why the campus name wins the search — and why that is not a CRO
Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:
- Hospital Universitario San Ignacio (Bogotá, Colombia): DEVICE n=6 (rank 26). Example DEVICE NCT IDs: NCT03084081, NCT03569254, NCT03570775.
- ALL interventional: n=47 (rank 26). ALL also lists NCT00545740, NCT00737529, NCT00950300.
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 “San Ignacio clinical trial Bogotá” finds a university hospital without finding INVIMA, import, insurance, or 21 CFR 812.28. Ranking n=6 DEVICE / n=47 ALL is registry volume, not a CRO product, and not a Santa Fe clone.
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 in Bogotá is not the INVIMA dossier. Resolución 2378 does not govern device clinical trials — see the live country pages rather than importing a drug-GCP resolution onto a device FIH.
- 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. We will not invent a campus-only premium here.
- ISO 14155 monitoring, EDC, SAE reporting, and the 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 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.
Site versus CRO
| Workstream | What San Ignacio (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Rooms, caseload, local staff, source documents | Protocol fit, training, device accountability |
| Ethics | Institutional committee calendar and local rules | Packet, ICF, IB alignment, deficiency cycle |
| National authority | Not the permit holder by appearing on an NCT | INVIMA clinical-investigation file |
| Import | Receiving and storage if contracted | Importer of record |
| Quality | Hospital or university quality and the case | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 narrative — eligibility, not clearance |
| Country optionality | One Bogotá university-hospital NCT string | Other Colombian sites and the rest of the bioaccess® platform |
How INVIMA actually works (the short version)
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 near the campus is not the INVIMA dossier. Resolución 2378 does not govern device clinical trials — see the live country pages rather than importing a drug-GCP resolution onto a device FIH.
Use CRO in Colombia and clinical-trials-colombia. INVIMA is published there as a PAHO/WHO Level 4 authority. 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 Colombian entity, INVIMA clocks in-country.
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 OUS FIH and FDA IDE.
Ask for a protocol-specific calendar. A hospital email is not INVIMA clearance. bioaccess® manages the file. That is CRO work, not site work.
Do not smear the hospital
Hospital Universitario San Ignacio is a serious Bogotá academic resource. n=47 ALL is registry volume. It is not a device-CRO quality system. Do not merge it into Fundación Santa Fe. bioaccess® still runs clinical trials in Colombia through a local Colombian entity; that is the operator layer, not a claim that we run this hospital.
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, IB, 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-Sub, IDE, 510(k), De Novo, PMA, or 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
A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. 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 Universitario San Ignacio 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, insurer, 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. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.
Is this the same page as Fundación Santa Fe de Bogotá?
No. Santa Fe is a separate Bogotá intercept. This page is Hospital Universitario San Ignacio only.
If I already have this campus, what does the CRO still do?
Regulatory-fit (this country versus Colombia versus a multi-site design); the INVIMA / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.
Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?
No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.
Is INVIMA slower than Panama ethics?
The published comparison already on the Panama country page is Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K. We pick the country the device needs. Ranking San Ignacio high on ALL is not a reason to skip INVIMA or to skip Colombia.
Does “local Colombian entity” mean the hospital is the applicant?
No. bioaccess®’s local Colombian entity is the operator stack. The hospital remains the site. An NCT location row does not make San Ignacio the INVIMA applicant.
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. Country: clinical trials in Colombia. Santa Fe sibling: Fundación Santa Fe de Bogotá FIH.
Julio G. Martinez-Clark, CEO · bioaccess®