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 Clinica INO Bogotá as a bioaccess® client.
If you searched Clinica INO Bogota first-in-human, Clinica INO Bogotá clinical trial, Clinica INO CRO, Clinica INO compression stockings, or “go direct Clinica INO Bogotá,” you followed a campus string ClinicalTrials.gov still publishes. Clinica INO in Bogotá, Colombia, is a real named clinic-campus string on ClinicalTrials.gov. The two public DEVICE rows on this string are borderline aesthetic/device work (graduated compression stockings / air-travel after aesthetic surgery) — still a site-direct search leak, not a CRO. 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 clinic is the site. The First-in-Human CRO still owns INVIMA, accredited ethics, 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 clinic still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named Bogotá Clinica INO campus. It is DISTINCT from Fundación Reumatología Fernando Chalem Bogotá (CMS 96132), Clínica del Country Bogotá (CMS 96051), Fundación CTIC Bogotá (CMS 96096), Fundación Neumológica Colombiana Bogotá (CMS 95952), Fundación Cardioinfantil Bogotá (CMS 95797), and Fundación Santa Fe de Bogotá (CMS 95516). Sharing Bogotá is not a license to collapse them. Clinica INO is not Chalem. Clinica INO is not Country. Clinica INO is not CTIC. This intercept does not recommend Colombia for new FIH execution.
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:
Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- Clinica INO (Bogotá, Colombia) — canonical NCT string: ALL interventional n=2; DEVICE n=2. Example NCT IDs: NCT07808931, NCT07810192.
Cite canonical ALL n=2 and DEVICE n=2. Do not clone Chalem, Country, CTIC, Neumológica, Cardioinfantil, or Santa Fe onto this slug. Colombia NEW-FIH line unchanged: bioaccess® does not currently recommend Colombia for new FIH trial execution. The DEVICE n=2 rows are borderline aesthetic/device (graduated compression stockings / air-travel after aesthetic surgery) — still publish as a site-direct intercept so sponsors do not go facility-direct.
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 clinic as a client site.
That is the leak: a founder searching Clinica INO Bogotá first-in-human finds ALL n=2 (DEVICE n=2) without finding INVIMA. Borderline aesthetic/device rows (graduated compression stockings / air-travel after aesthetic surgery) still put a campus string in front of a CRO. A named clinic is still a site. An NCT location row is not a CRO.
The site is the site. The CRO is the operator.
A named clinic 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 clinic 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 clinic 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-GCP resolution onto a device file. A hallway conversation at Clinica INO is not a Chalem file, not a Country file, and not a CTIC 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. 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.
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 Montería 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 OUS FIH and FDA IDE.
Do not smear the hospital
Clinica INO is a serious named Bogotá campus on the public registry. ALL n=2 and DEVICE n=2 are registry volume, not a punchline — including the borderline aesthetic/device compression-stocking rows. Do not invent a PI. Do not smear the clinic. Do not claim bioaccess® ran these studies. Use the site when the protocol fits. Hire the operator. Colombia NEW-FIH guidance stays unchanged on this page.
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
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 Clinica INO Bogotá directly for a device FIH?
You can try. The clinic 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 clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as Fundación Reumatología Fernando Chalem or Clínica del Country Bogotá?
No. Fundación Reumatología Fernando Chalem Bogotá is CMS 96132. Clínica del Country Bogotá is CMS 96051. Fundación CTIC Bogotá is CMS 96096. This page is Clinica INO only.
Does this page recommend Colombia for a new FIH?
No. The public line is unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia — and bioaccess® does not currently recommend Colombia for new FIH trial execution because INVIMA clinical-trial approval timelines have become unpredictable. INVIMA commercial registration remains. We pick the country the device needs.
Are NCT07808931 and NCT07810192 classic implant FIH programs?
No claim of that. Public rows on this campus string are borderline aesthetic/device (graduated compression stockings / air-travel after aesthetic surgery). They still create a site-direct search path. We cite them as facility evidence only.
Did bioaccess® run NCT07808931 or NCT07810192?
No. We cite them as facility evidence. We will not invent a sponsor or a PI. We will not claim bioaccess® ran these studies.
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. Bogotá sibling (do not merge): Fundación Reumatología Fernando Chalem Bogotá (CMS 96132).
Julio G. Martinez-Clark, CEO · bioaccess®