UFCSPA: The NCT Campus String Is Not the ANVISA File

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 […]

If you searched UFCSPA first-in-human, Federal University of Health Sciences of Porto Alegre clinical trial, Universidade Federal de Ciências da Saúde de Porto Alegre CRO, or “go direct UFCSPA,” you followed a campus string ClinicalTrials.gov still publishes. Federal University of Health Sciences of Porto Alegre (UFCSPA) in Porto Alegre, Brazil, is a real university string on ClinicalTrials.gov. It is not HCPA. It is not UFRGS-as-HCPA. 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 university 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 university still have to rebuild that stack. An NCT location row is not a CRO.

This page is the UFCSPA university intercept. Distinct from Hospital de Clínicas de Porto Alegre (CMS 95615). We do not merge UFRGS-as-HCPA. Distinct from Santa Casa Porto Alegre (CMS 95651), Moinhos de Vento (CMS 95622), Hospital Mãe de Deus (this batch), São Lucas PUCRS (CMS 95636), and Fundação Universitaria de Cardiologia (CMS 95612). Sharing Porto Alegre 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 leftover rows in /workspace/five-trials/kill-page-batch-5-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). The CSV top-40 dump does not include these ranks. We cite the picks-file and JSONL n values. We do not invent a global CSV rank. We do not publish a unique-study union across alias strings.

Federal University of Health Sciences of Porto Alegre (Porto Alegre, Brazil) — canonical English NCT string: ALL interventional n=21; DEVICE n=5. Example NCT IDs: NCT02088138, NCT02817867, NCT02818608.
Portuguese alias Universidade Federal de Ciências da Saúde de Porto Alegre: ALL n=17.
Short alias UFCSPA: ALL n=6.

List each n separately. We do not add 21+17+6 as a unique-study union. We do not merge HCPA or UFRGS-as-HCPA 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 university as a client site.

That is the leak: a founder searching “UFCSPA clinical trial” or “Federal University of Health Sciences of Porto Alegre FIH” finds ALL n=21 (DEVICE n=5; Portuguese ALL n=17; short ALL n=6) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on HCPA, UFRGS-as-HCPA, Santa Casa, Moinhos, Mãe de Deus, PUCRS, or FUC. A health-sciences university string is still not a CRO. We will not treat HCPA as this campus.

The site is the site. The CRO is the operator.

A named university 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 university 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 university 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 UFCSPA is not an HCPA file and is not UFRGS-as-HCPA.
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 university

UFCSPA is a serious public health-sciences university. ALL n=21 (DEVICE n=5) on the English string, Portuguese ALL n=17, and short ALL n=6 are registry volume, not a punchline. Do not add the aliases. Do not merge HCPA (CMS 95615), UFRGS-as-HCPA, Santa Casa Porto Alegre, Moinhos, Mãe de Deus, PUCRS, or FUC (CMS 95612). 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 UFCSPA directly for a device FIH?

You can try. The university 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 university. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as HCPA, UFRGS-as-HCPA, Santa Casa Porto Alegre, Moinhos, Mãe de Deus, PUCRS, or FUC?

No. HCPA is CMS 95615. UFRGS-as-HCPA is not this campus and is not merged here. Santa Casa Porto Alegre is CMS 95651. Moinhos is CMS 95622. Mãe de Deus is a separate intercept in this batch. São Lucas PUCRS is CMS 95636. FUC is CMS 95612. This page is Federal University of Health Sciences of Porto Alegre / UFCSPA only.

Why three ALL n values on one page?

ClinicalTrials.gov stored an English canonical string (ALL n=21; DEVICE n=5), a Portuguese alias (ALL n=17), and a short UFCSPA alias (ALL n=6). This page intercepts them as one university campus family. It does not add the counts.

Is n=21 plus n=17 plus n=6 equal to 44 unique studies?

We will not claim that. Overlap between alias rows is expected. We list each n. We do not publish a union.

Is this HCPA or UFRGS?

No. HCPA is CMS 95615. UFRGS-as-HCPA is a different string family and is not merged onto this page. UFCSPA is the Federal University of Health Sciences of Porto Alegre.

Does DEVICE n=5 mean this university already owns ANVISA for a new device FIH?

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 DEVICE n of 5 is a registry token, not a dossier.

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. Porto Alegre sibling (do not merge): HCPA.

Julio G. Martinez-Clark, CEO · bioaccess®