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 CONIS, 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 Clínica Bíblica as a bioaccess® client.
If you searched Hospital Clinica Biblica San Jose first-in-human, Clinica Biblica Costa Rica clinical trial, Biblica CRO, or “go direct Hospital Clínica Bíblica,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Clínica Biblica in San José, Costa Rica, is a real named hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the CONIS file.
bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns CONIS / Ministry of Health, accredited CEC, 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 named San José Bíblica campus. It is not a Panama MINSA file, not CEVAXIN (do not republish), and not a Costa Rica university we already intercept. Sharing Central America is not a license to collapse them. Bíblica is not CEVAXIN. A named hospital is still a site.
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 batch 52 (CMS 96102–96109 live) 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 We do not publish a unique-study union across alias strings.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 We do not invent unpublished CMS IDs.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.
- Hospital Clínica Biblica (San José, Costa Rica) — canonical NCT string: ALL interventional n=10; DEVICE n=0. Example NCT IDs: NCT00346216, NCT00410384, NCT00537940.
Cite canonical ALL n=10 and DEVICE n=0. Do not clone CEVAXIN onto this 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 hospital as a client site.
That is the leak: a founder searching “Clínica Bíblica first-in-human” finds ALL n=10 (DEVICE n=0) without finding CONIS. A named hospital 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:
- CONIS. CONIS / the Ministry of Health registers biomedical research after an accredited CEC. Ley N.° 9234 is the statute. Combined ethics + regulatory clocks on the live Costa Rica country page are typically ~30–90 days. A hallway conversation at this clinic is not that registration. A 3% CONIS canon on the study budget is a legal charge, not a CRO fee we invent here. A hallway conversation at Bíblica is not CONIS registration.
- 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 CONIS actually works (the short version)
Use clinical-trials-costa-rica. Costa Rica’s biomedical-research stack sits under Ley N.° 9234. An accredited CEC reviews the protocol first; then the study is registered with CONIS / the Ministry of Health. Combined ethics + regulatory clocks on the live country page are typically ~30–90 days. Confirm the current calendar with qualified advisers; an NCT location row is not CONIS registration. A statutory 3% CONIS canon on the study budget is published as a legal charge — not a CRO fee, and not a clinic markup we invent here. bioaccess® does not invent a Costa Rican legal entity on this page.
Ask for a protocol-specific calendar. A hospital email is not CONIS 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
Hospital Clínica Bíblica is a serious named San José campus on the public registry. ALL n=10 is registry volume, not a punchline. Do not invent a DEVICE n. 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, IB, ICF, insurance, and the CONIS / 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 Hospital Clínica Bíblica 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 CONIS 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.
Is this the same page as CEVAXIN?
No. We do not republish CEVAXIN. This page is Hospital Clínica Bíblica only.
Did bioaccess® run NCT00346216?
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. Start as the operator on the Costa Rica country page: clinical-trials-costa-rica.
Julio G. Martinez-Clark, CEO · bioaccess®