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 Clinica 20/20 as a bioaccess® client.
If you searched Clinica 20/20 first-in-human, Clinica 20 20 San José clinical trial, Clinica 20/20 CRO Costa Rica, or “go direct Clinica 20/20,” you followed a campus string ClinicalTrials.gov still publishes. Clinica 20/20 in San José, Costa Rica, is a real private clinic that appears on ClinicalTrials.gov as the facility string Clinica 20/20. 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 / MoH, 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 San José Clinica 20/20 intercept. It does not clone Clinica Canela. Canela is a different building, a different NCT family, and a different query. Linking is correct. Cloning that page is not. bioaccess® does not operate this clinic.
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:
- Clinica 20/20 (San José, Costa Rica): DEVICE n=8 (rank 17). Sponsor class on that row: INDUSTRY:8. Example NCT IDs: NCT04058314, NCT04059796, NCT04574102.
The same ranking dump has no ALL interventional row for this facility string. We will not invent an ALL n.
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 “Clinica 20/20 clinical trial” or “Costa Rica device FIH clinic” finds an industry-heavy DEVICE campus string without finding CONIS, the 3% statutory canon, import, insurance, or 21 CFR 812.28. Eight industry DEVICE rows are registry volume, not a CRO product, and not a claim that bioaccess® ran any of them.
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 and the Ministry of Health sit on Ley N.° 9234. Accredited CEC review, then CONIS registration. A hallway conversation in San José is not that 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.
Site versus CRO
| Workstream | What Clinica 20/20 (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 | CONIS / MoH 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 San José clinic string | Colombia (INVIMA) and the rest of the bioaccess® platform |
How CONIS / MoH actually works (the short version)
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 claim to operate this clinic and does not invent a Costa Rican legal entity on this page.
Use clinical-trials-costa-rica. 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 clinic email is not CONIS clearance. bioaccess® manages the file. That is CRO work, not site work.
Do not smear the hospital
Clinica 20/20 is a real San José clinic with industry DEVICE rows on a public ranking. That volume is not a punchline. This page is not a critique of those studies. It is also not a claim that the clinic is your FIH operator, that bioaccess® runs the clinic, or that we have a Costa Rican legal entity invented for this intercept. Use the site if the protocol fits. Hire the operator. Keep Clinica Canela on its own 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 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
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 Clinica 20/20 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. 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 Clinica Canela?
No. Canela is a separate Dominican / regional intercept already live. This page is Clinica 20/20 in San José, Costa Rica, under CONIS / Ley N.° 9234 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 CONIS / 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 the 3% CONIS charge a CRO fee?
No. It is a statutory canon on the study budget, as published on the Costa Rica country page. It is not a bioaccess® markup and not a clinic fee we invent here.
Does ranking INDUSTRY:8 mean bioaccess® was the sponsor?
No. INDUSTRY:8 is the ClinicalTrials.gov sponsor-class split on that DEVICE row. We will not invent those sponsors as clients. We will not invent 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. Country: clinical trials in Costa Rica.
Julio G. Martinez-Clark, CEO · bioaccess®