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 ANVISA, 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 CPCLIN as a bioaccess® client.
If you searched CPCLIN first-in-human, CPCLIN São Paulo clinical trial, CPCLIN CRO Brazil, or “go direct CPCLIN,” you followed a campus string ClinicalTrials.gov still publishes. CPCLIN in São Paulo, Brazil, is a real named research-clinic string on ClinicalTrials.gov. The named São Paulo research clinic is the site. It is not the CRO. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.
bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns ANVISA/CEP, 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 São Paulo research clinic. Distinct from CEPIC (CMS 95662), CPQuali (CMS 95671), Hospital Israelita Albert Einstein, Hospital do Coração (HCor), and Hospital Santa Marcelina. Sharing São Paulo or sharing a “C” research-clinic prefix is not a license to collapse them.
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 /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.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). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- CPCLIN (São Paulo, Brazil) — canonical NCT string: ALL interventional n=28; DEVICE n=0. Example NCT IDs: NCT01885078, NCT02963766, NCT03740919.
- Expanded legal-name NCT string: ALL n=13. Listed separately. Same slug. We do not invent the expanded corporate legal name on this page. We do not invent a unique-study union of 28+13. We do not ship a second slug for the expanded legal-name string.
Cite ALL n=28 as given on the canonical string. Cite expanded legal-name NCT string ALL n=13 separately. Do not add them. We will not invent a DEVICE 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 clinic as a client site.
That is the leak: a founder searching “CPCLIN São Paulo clinical trial” or the expanded legal-name NCT string finds ALL n=28 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CEPIC, CPQuali, Einstein, HCor, or Santa Marcelina. A named research 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:
- ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at CPCLIN is not a CEPIC, CPQuali, Einstein, HCor, or Santa Marcelina 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 ANVISA actually works (the short version)
Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.
Ask for a protocol-specific calendar. A hospital email is not ANVISA 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
CPCLIN is a serious named São Paulo research clinic on the public registry. ALL n=28 is registry volume, not a punchline, and not a claim that the clinic is a device CRO. Do not invent the expanded legal name. Do not merge it into CEPIC, CPQuali, Einstein, HCor, or Santa Marcelina. 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 ANVISA / 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 CPCLIN 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 ANVISA 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 CEPIC, CPQuali, Einstein, HCor, or Santa Marcelina?
No. CEPIC is CMS 95662. CPQuali is CMS 95671. Einstein, HCor, and Santa Marcelina are separate São Paulo intercepts. This page is CPCLIN only. The expanded legal-name NCT string stays on this slug; we list ALL n=13 separately and do not union.
What is the expanded legal-name NCT string?
The picks file records an expanded legal-name NCT string at ALL n=13. We cite that n. We will not invent the exact corporate name if it is not printed as a fact we will stand on. Same slug. No second count as a union.
Is CPCLIN the same as CEPIC or CPQuali?
No. CEPIC is Centro Paulista de Investigação Clínica (CMS 95662). CPQuali is CMS 95671. CPCLIN is a different NCT facility string. Sharing São Paulo and sharing a research-clinic prefix is not a merge.
Does “CLIN” in the name mean this clinic owns ANVISA?
No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. A clinic name is not a dossier.
Did bioaccess® run NCT03740919 because it also appears on another São Paulo clinic?
No. An NCT ID can list more than one facility. 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. Country: clinical trials in Brazil. São Paulo sibling (do not merge): CEPIC.
Julio G. Martinez-Clark, CEO · bioaccess®