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 Oncomedica S.A. Montería as a bioaccess® client.
If you searched Oncomedica Montería first-in-human, Oncomedica S.A. clinical trial, Oncomedica CRO Colombia, or “go direct Oncomedica S.A. Montería,” you followed a campus string ClinicalTrials.gov still publishes. Oncomedica S.A. in Montería, Colombia, is a real named oncology-clinic string on ClinicalTrials.gov. 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, 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 clinic still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named Montería oncology clinic. It is not Hospital Pablo Tobón Uribe (CMS 95624) and it is not Hospital Universitario San Ignacio (CMS 95631). Sharing a Colombian NCT search is not a license to collapse them. Montería is not Medellín and is not Bogotá. Site-number Oncomedica S.A. strings stay on this slug; we do not ship a second slug.
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 rows in /workspace/five-trials/kill-page-batch-10-picks-2026-09-02.md 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 We do not publish a unique-study union across alias strings.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.
- Oncomedica S.A. (Montería, Colombia) — canonical NCT string: ALL interventional n=22; DEVICE n=1. Example NCT IDs: NCT00542308, NCT00774345, NCT00910910.
Cite canonical ALL n=22 and DEVICE n=1. Site-number Oncomedica strings stay listed separately on this slug. We do not invent a unique-study union. We do not ship a second slug.
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 “Oncomedica Montería first-in-human” or “Oncomedica S.A. clinical trial Colombia” finds canonical ALL n=22 (DEVICE n=1) without finding INVIMA, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Pablo Tobón Uribe or San Ignacio. A named Montería 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 in Montería is not a Pablo Tobón Uribe file and is not a San Ignacio 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 clinic
Oncomedica S.A. is a serious named Montería oncology clinic on the public registry. ALL n=22 and DEVICE n=1 are registry volume, not a punchline. Do not merge it into Pablo Tobón Uribe or San Ignacio. Do not invent a PI. Use the site when the protocol fits. Hire the operator. bioaccess® still runs clinical trials in Colombia.
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 Oncomedica S.A. Montería 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 Hospital Pablo Tobón Uribe or Hospital Universitario San Ignacio?
No. Pablo Tobón Uribe is CMS 95624 in Medellín. San Ignacio is CMS 95631 in Bogotá. This page is Oncomedica S.A., Montería only. Site-number strings stay on this slug; we do not union.
Is this Hospital Pablo Tobón Uribe?
No. That is CMS 95624 in Medellín. Montería versus Medellín is the filter. A Colombian NCT string is not a merge key.
Is this Hospital Universitario San Ignacio?
No. That is CMS 95631 in Bogotá. This page is Oncomedica S.A. in Montería.
Why DEVICE n=1?
That is the ranking-table DEVICE count for this string. It is still not INVIMA authorization. Colombia ethics typically 4–6 weeks and per-patient $15,000–$25,000 on the published Panama comparison. We pick the country the device needs.
Did bioaccess® run NCT00542308?
No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.
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. Colombia sibling (do not merge): Hospital Pablo Tobón Uribe. Panama comparison clocks: clinical trials in Panama.
Julio G. Martinez-Clark, CEO · bioaccess®