Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Universidade Metodista de Piracicaba (UNIMEP) as a bioaccess® client.
If you searched Universidade Metodista de Piracicaba first-in-human, UNIMEP clinical trial, Metodista Piracicaba device study, or “go direct Universidade Metodista de Piracicaba (UNIMEP),” you followed a campus string ClinicalTrials.gov still publishes. Universidade Metodista de Piracicaba (UNIMEP) in Piracicaba, Brazil, is a real named university-campus string on ClinicalTrials.gov. No separate live university-string page for UNIMEP exists yet. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.
bioaccess®’s position is simple and it is not adversarial: the university campus is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 campus still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named UNIMEP university string in Piracicaba. It is DISTINCT from Piracicaba Dental School / Unicamp (CMS 96372), a separately named dental-school campus of a different university in the same city. Sharing Piracicaba is not a license to collapse them. This is the whole university string, not a lab or school subunit of a university that already has a live page.
Why the campus name wins the search — and why that is not a CRO
Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:
Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in Piracicaba, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not union separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- Universidade Metodista de Piracicaba (Piracicaba, Brazil) — registry strings counted: “Universidade Metodista de Piracicaba”; “Universidade Metodista de Piracicaba (UNIMEP)”. ALL studies n=9; interventional n=9; DEVICE n=1. Example NCT IDs: NCT01484834, NCT01786681, NCT01841385.
Cite ALL n=9 and DEVICE n=1. Aliases including UNIMEP are counted once per NCT ID for Piracicaba locations. Do not clone Piracicaba Dental School 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 campus as a client site.
That is the leak: a founder searching Universidade Metodista de Piracicaba finds ALL n=9 (DEVICE n=1) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.
The site is the site. The CRO is the operator.
A named university campus 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 campus 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 campus is not built to own for an investigational device:
- ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UNIMEP is not a Piracicaba Dental School / Unicamp file and is not an ANVISA 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
- ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (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 outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).
Do not smear the university
Universidade Metodista de Piracicaba is a serious named Brazilian university campus on the public registry. ALL n=9 and DEVICE n=1 are registry volume, not a punchline. 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 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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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 Universidade Metodista de Piracicaba (UNIMEP) directly for a device FIH?
You can try. The university campus can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurance coordinator, 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 campus. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as Piracicaba Dental School (Unicamp)?
No. piracicaba-dental-school-fih (CMS 96372) is a distinct Unicamp dental-school campus already live. This page is the UNIMEP university string only.
Did bioaccess® run NCT01484834?
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. Piracicaba sibling (do not merge): Piracicaba Dental School.
Julio G. Martinez-Clark, CEO · bioaccess®