Category: Navigating Regulatory Landscapes in Latin America

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and the published bioaccess® Brazil country page. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the merged facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Universidade Nove de Julho as a bioaccess® client.

If you searched Universidade Nove de Julho first-in-human, University of Nove de Julho CRO, Nove de Julho University clinical trials, or “go direct UNINOVE São Paulo,” you followed campus strings ClinicalTrials.gov still publishes as three separate labels. They are one university. They are not a first-in-human medical-device CRO, and they are not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the campus 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 São Paulo 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 merges three accent/language aliases into one page: Universidade Nove de Julho, University of Nove de Julho, and Nove de Julho University. It does not repeat InCor HCFMUSP or Dante Pazzanese. Those are different São Paulo buildings.

Why the three spellings win the search — and why that is not a CRO

ClinicalTrials.gov stores Portuguese and English campus names as separate facility keys. On the 1 September 2026 LATAM DEVICE sweep they sit as:

• Universidade Nove de Julho: DEVICE rank 9, n=11. Example NCT IDs: NCT02588768, NCT02591680, NCT02715050.
• University of Nove de Julho: DEVICE rank 14, n=9. Example NCT IDs: NCT01984021, NCT02057120, NCT02398344.
• Nove de Julho University: DEVICE rank 27, n=6. Example NCT IDs: NCT01844271, NCT02474602, NCT02498249.

Public snapshots of those IDs list lead sponsor University of Nove de Julho (or the Portuguese equivalent) and the matching location string. Brief titles cluster around photobiomodulation / phototherapy, low-level laser, kinesio taping, acupuncture on trapezius, neuromuscular stimulus, and tDCS in hemiparesis. 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. Combined DEVICE n=11+9+6 is how a sponsor searching any of the three spellings finds a campus without finding an operator.

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

A São Paulo private university can provide labs, coordinators, institutional CEP calendars, and investigators who have already appeared on NCT rows under three English/Portuguese spellings. 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 lab.
• Share institutional CEP calendars and university 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). Three NCT spellings do not become that dossier.
• CEP. Institutional ethics under Law 14874. The CEP is tied to the host institution once the site is chosen.
• Investigational import — a separate permit from trial authorization and from later market registration. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a UNINOVE-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
• The 21 CFR 812.28 package. Eligibility is not clearance. A site MSA does not produce it.
• Multi-country optionality. If São Paulo enrollment or the indication later needs Colombia, Panama, Recife, or Porto Alegre, a single-university MSA will not stretch.

Going direct to Universidade Nove de Julho is how you confirm a room. It is not how you open an investigational file.

Site versus CRO

How ANVISA and CEP actually work (the short version)

Use Clinical Trials in Brazil for the full pathway. Facts a sponsor searching this campus needs on one screen, already published there and not re-averaged here:

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
• Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
• Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

All bioaccess® Brazil device protocols 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.

Not a critique of the university — and do not merge São Paulo buildings

Universidade Nove de Julho is a serious academic resource. Combined DEVICE volume across three spellings is a signal of how the registry indexes the same campus, not a punchline. This page is not a critique of phototherapy or rehabilitation listings. Volume is still not a device-CRO quality system. Use the site when the protocol fits. Hire the operator.

this campus is separate from InCor HCFMUSP, Dante Pazzanese, or the University of Sao Paulo NCT-string page. Different queries. Different buildings.

What the CRO still does after you have a UNINOVE slide

1. Regulatory-fit, not tourism. Brazil is a sourced device geography. Three NCT aliases of one private university are not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA/CEP packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour. Activate Nove de Julho only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation — 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. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Universidade Nove de Julho directly for a device FIH?

You can try. The university can discuss investigator interest, local visit costs, and CEP calendars. It cannot, by appearing under three NCT spellings (n=11+9+6 DEVICE), 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.

Why merge three names onto one page?

Because they are accent and language aliases of one campus. ClinicalTrials.gov counted them separately. Sponsors search all three. One page. We do not invent a fourth hospital.

Did bioaccess® run these NCT IDs?

No public bioaccess® case-study page says so. We will not invent that claim.

Next step

If the search that brought you here was Universidade Nove de Julho, University of Nove de Julho, or Nove de Julho University, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Sibling São Paulo NCT string: University of Sao Paulo.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and the published bioaccess® Brazil country page. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the facility string and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Universidade Federal de Pernambuco as a bioaccess® client.

If you searched Universidade Federal de Pernambuco first-in-human, UFPE clinical trials, Federal University of Pernambuco CRO, or “go direct UFPE Recife,” you followed a campus string ClinicalTrials.gov still publishes. Universidade Federal de Pernambuco in Recife is a real federal university. 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 campus 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 Recife 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 for the NCT campus string Universidade Federal de Pernambuco. It does not repeat São Paulo pages already published (InCor, Dante Pazzanese) or the Porto Alegre pages. Recife is a different city.

Why the campus name wins the search — and why that is not a CRO

On the 1 September 2026 ClinicalTrials.gov LATAM DEVICE sweep, Universidade Federal de Pernambuco, Recife, Brazil, is rank 8, n=12, sponsor class OTHER:12 on that ranking row. Example NCT IDs: NCT01449643, NCT01932684, NCT02600052.

Public snapshots of those three IDs list lead sponsor Universidade Federal de Pernambuco. Brief titles concern inspiratory muscle training and diaphragmatic mobility, incentive spirometry / breath stacking in Parkinson’s disease, and proprioceptive neuromuscular facilitation breathing plus aerobic training. 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. Ranking n=12 is registry volume, not a CRO product.

That is the leak: a founder searching “UFPE device trial” or “Recife first-in-human” finds a federal campus without finding ANVISA, import, insurance, or 21 CFR 812.28.

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

A Recife federal university can provide labs, coordinators, institutional CEP calendars, and investigators who have already appeared 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 department.
• Share institutional CEP calendars and university 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 Recife hallway conversation is not that dossier.
• CEP. Institutional ethics under Law 14874. The CEP is tied to the host institution once the site is chosen.
• Investigational import into Brazil is a separate permit from trial authorization and from later market registration. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a Recife-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
• The 21 CFR 812.28 package. Eligibility is not clearance. A site MSA does not produce it.
• Multi-country optionality. If Recife enrollment or the indication later needs São Paulo, Porto Alegre, Bogotá, or Panama City, a single-campus MSA will not stretch.

Going direct to Universidade Federal de Pernambuco is how you confirm a room. It is not how you open an investigational file.

Site versus CRO

How ANVISA and CEP actually work (the short version)

Use Clinical Trials in Brazil for the full pathway. Facts a sponsor searching this campus needs on one screen, already published there and not re-averaged here:

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
• Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
• Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

All bioaccess® Brazil device protocols 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.

Not a critique of the university

Universidade Federal de Pernambuco is a serious academic resource. Ranking eighth on a public DEVICE facility list is a signal of registry volume, not a punchline. This page is not a critique of physiotherapy or respiratory-device listings on ClinicalTrials.gov. Volume is still not a device-CRO quality system. Use the site when the protocol fits. Hire the operator. Recife is separate from InCor, Dante Pazzanese, or Hospital de Clínicas de Porto Alegre.

What the CRO still does after you have a UFPE slide

1. Regulatory-fit, not tourism. Brazil is a sourced device geography. Recife is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA/CEP packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour. Activate UFPE only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation — 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. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Universidade Federal de Pernambuco directly for a device FIH?

You can try. The university can discuss investigator interest, local visit costs, and CEP calendars. It cannot, by ranking n=12 on the DEVICE sweep, 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 NCT01449643, NCT01932684, or NCT02600052?

No public bioaccess® case-study page says so. We will not invent that claim. This page answers the search; it does not claim the studies.

If I already have Recife, what does the CRO still do?

Regulatory-fit (Brazil vs Colombia vs a multi-site Brazil design); the ANVISA/CEP packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one Recife room is not enough.

Next step

If the search that brought you here was Universidade Federal de Pernambuco or UFPE, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and the ClinicalTrials.gov record for NCT06991270 (pulled 19 October 2026). Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the NCT facility string “Panama Eye Center” and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Panama Eye Center as a bioaccess® client.

If you searched Panama Eye Center first-in-human, Panama Eye Center CRO, Panama Eye Center clinical trials, or “go direct Panama Eye Center,” you followed the exact location string ClinicalTrials.gov still publishes. Panama Eye Center in Panama City is a real ophthalmic facility string in the public file. It is not a first-in-human medical-device CRO, and it is not the operator of the MINSA device file.

bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns MINSA/CNBI, 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 Panama City 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 for the NCT campus string Panama Eye Center (n=13 DEVICE studies on the 1 September 2026 sweep — the highest new Panama device site after The Panama Clinic / CEVAXIN strings already published). It does not repeat the live MINIject / STAR-I page Panama Eye Centre / Orillac-Calvo MINIject. That page is a different query: NCT03193736 STAR-I and the British Journal of Ophthalmology site name. We do not invent PIs to reconcile spellings.

Why the campus string wins the search — and why that is not a CRO

Device registries write the implant class, the city, and the facility name. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM DEVICE sweep, Panama Eye Center, Panama City, Panama, is rank 7, n=13, all INDUSTRY-sponsored in that ranking row. Example NCT IDs: NCT03374553, NCT03996200, NCT04517786.

Public snapshots of those three IDs list lead sponsor iSTAR Medical and location facility Panama Eye Center (alongside other countries’ eye hospitals on some records). Brief titles concern MINIject in open-angle glaucoma. That is facility evidence for this NCT string. It is not a reason to republish the STAR-I / Orillac-Calvo page. We will not invent a PI. We will not claim bioaccess® ran these NCTs. No live bioaccess® case-study page names this clinic as a client. iSTAR Medical / MINIject is not claimed as a bioaccess® client here either — the live STAR-I page already says the same.

That is the leak: a founder searching “Panama Eye Center clinical trial” finds n=13 device rows without finding MINSA, CNBI, import, insurance, or 21 CFR 812.28. Ranking after TPC/CEVAXIN is a registry fact, not a CRO product.

Registry update: Sight Sciences OMNI 3.1 pilot (NCT06991270)

A newer industry device record also lists this facility string. NCT06991270 is titled “A Pilot Study of the OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma.” The lead sponsor is Sight Sciences, Inc., classed on the record as industry, and the sponsor is the responsible party. The record lists no collaborator and no contract research organization, and it names no principal investigator. We do not add one.

What the ClinicalTrials.gov record shows (API v2 pull, 19 October 2026):

• Site: one location, Panama Eye Center, Panama City, Panama.
• Design: interventional, single group, no masking; phase listed as not applicable.
• Enrollment: 25 participants (estimated).
• Start: 8 October 2025 (actual).
• Status: active, not recruiting.
• Last update posted: 19 October 2026.
• Procedure as registered: canaloplasty and trabeculotomy, either combined with phacoemulsification cataract surgery or as a standalone procedure in pseudophakic eyes. The title names OMNI 3.1; the arm and intervention fields name the OMNI 3.0 Surgical System.
• Stated aim: early evidence of safety and of intraocular pressure (IOP)-lowering effectiveness in mild-to-moderate primary open-angle glaucoma (POAG).
• Results: none posted on the record.

That is registry evidence for the Panama Eye Center string, nothing more. This page makes no efficacy or regulatory-status claim for any OMNI version. We do not claim bioaccess® ran or supported NCT06991270, and Sight Sciences is not presented here as a bioaccess® client. As with the other rows on this string, the registry entry does not show who handles the MINSA and CNBI submissions, investigational import, or monitoring.

Registry update: Alcon accommodating IOL feasibility study (NCT07147192), now terminated

A more recent industry device record also lists this facility string. NCT07147192 is titled “Feasibility Study of an Accommodating IOL Design” (IOL: intraocular lens). The lead sponsor is Alcon Research, classed on the record as industry, and the sponsor is the responsible party. The record lists no collaborator and no contract research organization (CRO), and it names no principal investigator; the only named official is a sponsor role, “Clinical Trial Lead, Surgical,” listed as study director. We do not add a name.

What the ClinicalTrials.gov record shows (API v2 pull, 2 November 2026):

• Sites: four locations — Clinica 20/20, San José, Costa Rica; Instituto Espaillat Cabral, Santo Domingo, Dominican Republic; Centro Panamericano de Ojos / Clinica Lopez Beltran, San Salvador, El Salvador; and Panama Eye Center, Panama City, Panama. Panama Eye Center is the Panama row. No per-site status is shown.
• Design: interventional device-feasibility study; non-randomized, with contralateral implantation (one eye receives the AAL-FAIOL lens and the other the BAL-FAIOL lens, after phacoemulsification cataract surgery); no masking; phase listed as not applicable.
• Status: terminated. Reason given on the record: “Management Decision.”
• Enrollment: 17 participants (actual), across the whole study. The record does not break this down by site.
• Dates: actual start 3 December 2025; actual primary completion and actual study completion 22 October 2026; first posted 29 August 2025; last update posted 29 October 2026.
• Results: none posted on the record.

That is registry evidence for the Panama Eye Center string, nothing more. This page makes no safety, effectiveness or regulatory-status claim for either lens, and it does not guess how many participants this site enrolled. We do not claim bioaccess® ran or supported NCT07147192, and Alcon is not presented here as a bioaccess® client. As with the other rows on this string, the registry entry does not show who handled the MINSA and CNBI submissions, investigational import, or monitoring. The sister rows have their own pages: Clinica 20/20, Instituto Espaillat Cabral and Centro Panamericano de Ojos / Clínica López Beltrán.

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

A Panama City eye clinic can provide an OR, imaging, and coordinators who have already appeared on industry device 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 ophthalmic service.
• Share institutional ethics-committee calendars and local 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:

• MINSA and CNBI. The national device file is not a hallway conversation with a coordinator.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages, not a clinic email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The premium depends on device risk, enrollment, and the insurer’s review of the protocol; get a quote for your study rather than relying on a planning band.
• 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. Eligibility is not clearance. A site MSA does not produce it.
• Multi-country optionality. If Panama enrollment or the indication later needs Colombia, El Salvador, Brazil, or another bioaccess® market, a single-clinic MSA will not stretch.

Going direct to Panama Eye Center is how you confirm a room. It is not how you open a first-in-human device investigation.

Site versus CRO

How MINSA and CNBI actually work (the short version)

Use the country pages for the full pathway. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national health authority sponsors meet on device investigations. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI).

Timelines and costs depend on the protocol, so this page does not quote a generic number. What drives the calendar and the budget:

• The institutional ethics committee’s meeting calendar and how complete the first submission is.
• Questions from the committee or MINSA, and how quickly the sponsor answers them.
• The investigational import permit and device shipping.
• Site preparation, contracts, training, and screening before the first patient.
• Device risk, procedure and imaging costs, visit schedule, and follow-up length, which drive per-patient cost.

Ask for a protocol-specific calendar. Do not treat a clinic hallway estimate as MINSA clearance. bioaccess® manages the submission and keeps the reviewer relationship. That is CRO work, not site work.

All bioaccess® Panama protocols 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.

Separate from the STAR-I page — not a critique of the clinic

Panama Eye Center is a serious ophthalmic resource on the public NCT file. This page is not a critique of that work. A cluster of industry glaucoma-device rows is a signal of registry volume, not a substitute for a CRO quality system. Use the site when the protocol fits. Hire the operator.

For STAR-I / Orillac-Calvo / Panama Eye Centre (British spelling) stay on Panama Eye Centre / Orillac-Calvo MINIject. For hospital-named Panama City FIH stay on The Panama Clinic first-in-human. For the vaccine-network brand stay on CEVAXIN FIH. Those are different queries.

What the CRO still does after you have a Panama Eye Center slide

1. Regulatory-fit, not tourism. Panama is fast and bilingual. An ophthalmic NCT string is not automatically the right room for every device indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour. Activate Panama Eye Center only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation — eligibility, not a promise of FDA action.

bioaccess® has been active in Panama since the early 2010s. 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. Ethics calendars, per-patient costs, and enrollment pace differ by country, site, and protocol, so we compare them for the specific device rather than quoting a generic band. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Panama Eye Center directly for a device FIH?

You can try. A clinic can discuss investigator interest, local visit costs, and institutional ethics calendars. It cannot, by appearing as n=13 DEVICE rows, become your MINSA/CNBI 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.

Is this the MINIject / Orillac-Calvo page?

No. That page is Panama Eye Centre / Orillac-Calvo MINIject for STAR-I (NCT03193736). This page is the NCT campus string “Panama Eye Center” (n=13). Some of those n=13 rows are other iSTAR MINIject listings. Linking is correct. Cloning is not. We do not invent a PI to merge the spellings.

Did bioaccess® run NCT03374553, NCT03996200, or NCT04517786?

No public bioaccess® case-study page says so. We will not invent that claim.

Next step

If the search that brought you here was Panama Eye Center, start as the operator: contact bioaccess® or book from First-in-Human CRO. STAR-I sibling: Panama Eye Centre / Orillac-Calvo MINIject. Hospital: The Panama Clinic first-in-human. Country: clinical trials in Panama.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and the published bioaccess® Brazil country page. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the NCT facility string “University of Sao Paulo” and example NCT IDs those sources support. We do not invent InCor, HCFMUSP, or a principal investigator on this page. We do not claim University of Sao Paulo as a bioaccess® client.

If you searched University of Sao Paulo first-in-human, University of Sao Paulo CRO, USP clinical trials Brazil device, or “go direct University of Sao Paulo,” you followed the exact location string ClinicalTrials.gov still publishes. University of Sao Paulo is a real university. 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 campus string is the site label. 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 São Paulo 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 answers the registry string University of Sao Paulo only. It does not invent InCor or HCFMUSP as this page’s campus. Heart-institute searches already have a live page: InCor HCFMUSP. “University of Sao Paulo General Hospital” is a different NCT string (DEVICE n=7 on the same sweep) and is not merged here.

Why the NCT string wins the search — and why that is not a CRO

Sponsors type what the registry prints. On the 1 September 2026 ClinicalTrials.gov LATAM sweep, the facility string University of Sao Paulo, São Paulo, Brazil, is DEVICE rank 5, n=15, and ALL interventional rank 6, n=73. Example DEVICE NCT IDs: NCT01033084, NCT01149213, NCT01525524.

Public snapshots of those three IDs list lead sponsor University of Sao Paulo and location facility University of Sao Paulo. Brief titles on those records are transcranial direct current stimulation studies in major depressive disorder, including post-stroke depression. We cite the IDs as facility evidence. We will not invent a PI. We will not claim they are first-in-human device programs bioaccess® ran. We will not stretch them into a heart-institute claim. No live bioaccess® case-study page names this NCT string as a client site.

That is the leak: a founder searching “University of Sao Paulo clinical trial” or “USP FIH Brazil” finds a campus without finding ANVISA, import, insurance, or 21 CFR 812.28. Ranking n=15 device studies is registry volume, not a CRO product.

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

A São Paulo university campus can provide rooms, coordinators, institutional CEP calendars, and investigators who have already appeared on NCT rows under this English facility string. 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 lab or clinic.
• Share institutional CEP calendars and university 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). A campus email is not that dossier.
• CEP. Institutional ethics under Law 14874. The CEP is tied to the host institution once the site is chosen.
• Investigational import — a separate permit from trial authorization and from later market registration. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a USP-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
• The 21 CFR 812.28 package. Eligibility is not clearance. A site MSA does not produce it.
• Multi-country optionality. If São Paulo enrollment or the indication later needs Colombia, Panama, or another campus, a single-university MSA will not stretch.

Going direct to the University of Sao Paulo NCT string is how you confirm a label. It is not how you open an investigational file.

Site versus CRO

How ANVISA and CEP actually work (the short version)

Use Clinical Trials in Brazil for the full pathway. Facts a sponsor searching this campus needs on one screen, already published there and not re-averaged here:

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
• Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
• Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

All bioaccess® Brazil device protocols 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.

Sibling heart-institute page — do not merge it here

If the search you actually meant was Instituto do Coração / HCFMUSP / InCor, stay on InCor HCFMUSP. That page already covers public device rows such as Cephea and Leaflex under InCor spellings. This page will not copy those claims onto “University of Sao Paulo.” The Brazil country page already notes that São Paulo’s Hospital das Clínicas is one of the largest medical complexes in Latin America as a landscape fact; bioaccess® does not claim to operate that hospital. Dante Pazzanese remains a separate page. This is not a critique of the university.

What the CRO still does after you have a USP slide

1. Regulatory-fit, not tourism. Brazil is a sourced device geography. An English NCT campus string is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA/CEP packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour. Activate a University of Sao Paulo site only if it fits the protocol — and only the building the protocol actually needs, not a merged InCor identity.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation — 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. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract University of Sao Paulo directly for a device FIH?

You can try. A university can discuss investigator interest, local visit costs, and CEP calendars. It cannot, by appearing as n=15 DEVICE / n=73 ALL 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.

Is this the InCor page?

No. InCor / HCFMUSP is already published at InCor HCFMUSP. This page is the NCT string “University of Sao Paulo” only.

Did bioaccess® run NCT01033084, NCT01149213, or NCT01525524?

No public bioaccess® case-study page says so. We will not invent that claim.

Next step

If the search that brought you here was University of Sao Paulo, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Heart-institute sibling: InCor HCFMUSP.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and the published bioaccess® Brazil country page. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, 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 de Clínicas de Porto Alegre as a bioaccess® client.

If you searched Hospital de Clínicas de Porto Alegre first-in-human, HCPA clinical trials, Hospital de Clinicas de Porto Alegre CRO, or “go direct HCPA Brazil,” you followed a campus string ClinicalTrials.gov still publishes. Hospital de Clínicas de Porto Alegre (HCPA) in Porto Alegre, Rio Grande do Sul, is a real university hospital. 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 hospital 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 Porto Alegre 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 covers three registry spellings of the same campus. ClinicalTrials.gov stores them as separate facility strings; we do not. Accented Hospital de Clínicas de Porto Alegre, unaccented Hospital de Clinicas de Porto Alegre, and Hospital de Clinicas e Porto Alegre (HCPA) are one page. It does not repeat Fundação Universitaria de Cardiologia Porto Alegre. That is a different hospital, on a different NCT (Polares MRace / NCT06113354). Linking is correct. Cloning that Polares page is not.

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 DEVICE studies; all years), this campus sits at the top of named Brazilian device facilities after filters:

• Hospital de Clínicas de Porto Alegre (accented): DEVICE rank 1, n=30. Example NCT IDs: NCT00761280, NCT00921791, NCT02105064.
• Hospital de Clinicas de Porto Alegre (unaccented): DEVICE rank 3, n=26. Example NCT IDs: NCT00489463, NCT00929175, NCT01133223.
• Hospital de Clinicas e Porto Alegre (HCPA): DEVICE rank 36, n=5. Example NCT IDs: NCT01954277, NCT02432677, NCT03744897.

On the same sweep’s ALL interventional ranking (not device-only): accented n=293 (rank 1) and unaccented n=213 (rank 2). 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 not a quality score. They are how a sponsor searching “Porto Alegre hospital clinical trial” lands on a campus without landing on an operator.

Public snapshots of those example IDs show mixed hospital- and industry-sponsored interventional work. 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.

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

A Porto Alegre university hospital can provide rooms, coordinators, institutional CEP calendars, and investigators who have already appeared on hundreds of 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 CEP 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:

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation in Porto Alegre is not that dossier.
• CEP. Institutional ethics under Law 14874. The CEP is tied to the host institution once the site is chosen.
• Investigational import into Brazil is a separate permit from trial authorization and from later market registration. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent an HCPA-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 Porto Alegre enrollment or the indication later needs São Paulo, Bogotá, or Panama City, a single-hospital MSA will not stretch.

Going direct to Hospital de Clínicas de Porto Alegre is how you confirm a room. It is not how you open an investigational file.

Site versus CRO

How ANVISA and CEP actually work (the short version)

Use Clinical Trials in Brazil for the full pathway. Facts a sponsor searching this campus needs on one screen, already published there and not re-averaged here:

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
• Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
• Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

All bioaccess® Brazil device protocols 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.

Not a critique of the hospital — and do not merge Porto Alegre buildings

Hospital de Clínicas de Porto Alegre is a serious academic resource. Ranking first on a public DEVICE facility list is a signal of registry volume, not a punchline. This page is not a critique of that work. Volume on ClinicalTrials.gov is still not a device-CRO quality system. Use the site when the protocol fits. Hire the operator.

this campus is separate from Fundação Universitaria de Cardiologia. It is separate from São Paulo pages already published: InCor HCFMUSP and Instituto Dante Pazzanese. Different buildings. Different queries.

What the CRO still does after you have an HCPA slide

1. Regulatory-fit, not tourism. Brazil is a sourced device geography. One Porto Alegre campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA/CEP packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate HCPA only if it fits the protocol.
5. 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. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital de Clínicas de Porto Alegre directly for a device FIH?

You can try. The hospital can discuss investigator interest, local visit costs, and CEP calendars. It cannot, by ranking high 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 hospital. We will not invent that claim. This page answers the search; it does not claim the studies. Registry n=30+26+5 (DEVICE) and n=293+213 (ALL) are ClinicalTrials.gov counts, not bioaccess® enrollment.

Is this the same hospital as Fundação Universitaria de Cardiologia?

No. Fundação Universitaria de Cardiologia is a different Porto Alegre facility already published for Polares MRace (NCT06113354). This is the HCPA campus-string page.

If I already have HCPA, what does the CRO still do?

Regulatory-fit (Brazil vs Colombia vs a multi-site Brazil design); the ANVISA/CEP packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one Porto Alegre room is not enough.

Next step

If the search that brought you here was Hospital de Clínicas de Porto Alegre or HCPA, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Other Porto Alegre hospital: Fundação Universitaria de Cardiologia.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from CEVAXIN public pages (retrieved 1 September 2026), ClinicalTrials.gov NCT06673264, and published bioaccess® Panama and case-study pages. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the facility, sponsor, and trial those sources support. We do not invent a principal investigator the NCT did not publish. We do not claim CEVAXIN as a bioaccess® client.

If you searched CEVAXIN first-in-human, CEVAXIN CRO, CEVAXIN Panama clinical trials, or “go direct CEVAXIN Panama,” you followed a research-center brand that is genuinely in the public file. Centro de Vacunación e Investigación SA (CEVAXIN) is a real Panama site network. It is not a first-in-human medical-device CRO, and it is not the operator of the MINSA device file.

bioaccess®’s position is simple and it is not adversarial: CEVAXIN is a site. The First-in-Human CRO still owns MINSA/CNBI, 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 a CEVAXIN room is not the only fit. Sponsors who skip the CRO and email the research center still have to rebuild that stack. A vaccine-trial brand does not become a device CRO because a founder typed “CEVAXIN CRO.”

This page is the CEVAXIN-brand page. It does not repeat The Panama Clinic first-in-human (the hospital-name page, The Panama Clinic First-in-Human Device Trials) or the NCT hyphen page CEVAXIN / The Panama Clinic FIH. Those stay the building query and the registry-string query. This page answers the CEVAXIN-only search.

Why the CEVAXIN name wins the search — and why that is not a CRO

Site marketing writes the studies, the volunteer count, and the MINSA endorsement. It rarely writes a device CRO. CEVAXIN’s own about page (retrieved 1 September 2026) is the clean public example:

• Medical research center founded in 2013 in the Republic of Panama.
• Public claims: more than ten years; +40 clinical studies; +25,000 participants; +15 national and international sponsors; more than 200 research professionals.
• Five Panama sites: The Panama Clinic, 24 de diciembre, Chorrera, and (on the same page) Avenida México and Chiriquí.
• The work it advertises: clinical, epidemiological, and public-health studies of vaccine-preventable disease — polio, dengue, RSV, zoster, norovirus, pneumococcus, hepatitis A, meningitis, pertussis, chikungunya, COVID-19 — under national ethics committees and MINSA endorsement.
• Staff specialties named on that page: pediatrics, epidemiology, pneumology, internal medicine, tropical medicine, health economics.

That copy is useful. It is how a sponsor finds a Panama research center without finding a device operator. It is also how a founder concludes that “CEVAXIN CRO” is the whole first-in-human plan. It is not. MINSA still exists after you have the brand. Pediatrics and vaccine epidemiology on a staff page do not become ISO 14155 device monitoring, an investigational-device importer of record, or a 21 CFR 812.28 package.

This article will not invent a bioaccess® relationship CEVAXIN’s pages do not contain. We do not claim CEVAXIN as a client.

The public device NCT is a location string, not a CRO product

One completed device registry row lists CEVAXIN as a facility. Read it as a location string.

NCT06673264, retrieved 1 September 2026: FINESSE, first-in-human soft neural probe; lead sponsor Axoft, Inc. (INDUSTRY); no collaborator; no CRO; status COMPLETED; actual enrollment 5; actual start 14 March 2025; completion 21 August 2025. The only location row is Centro de Vacunación e Investigación SA (CEVAXIN) – The Panama Clinic, Panama City, Panama. No central contacts, no overall officials, no site investigators on that snapshot. We will not invent a PI name to fill that blank.

That NCT is how a “CEVAXIN first-in-human” search leaks into device FIH. It is not proof that CEVAXIN sells a device-CRO stack. Axoft has said it partnered with bioaccess® to enable that study; the Axoft — Panama First-in-Human case study cites four patients implanted during brain-tumor resection at The Panama Clinic, ethics ~4 weeks, FDA Breakthrough 2022, $55M Series A April 2026 as cited on that page. The NCT did not name the CRO. We will not pretend it did. We will not invent a reconciliation of 4 versus 5 beyond what each page already prints.

Newrotex — SilkAxons™ is the case study for the SilkAxons™ first-in-human trial at The Panama Clinic (world-first SilkAxons™ implant; FIH start August 2025), for which Newrotex has said bioaccess® was its CRO partner. It is not a CEVAXIN-client claim.

CEVAXIN is a site. The CRO is the operator.

A Panama vaccine and epidemiology network can provide rooms, coordinators, volunteer pipelines, and investigators who have run MINSA-endorsed public-health studies. That is necessary for the work they publish. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What a research center can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing site.
• Share institutional ethics-committee calendars and local research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the center is not built to own for an investigational device:

• MINSA and CNBI. The national device file is not a hallway conversation with a research coordinator.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages, not a site email.
• Clinical trial insurance. Required. The Panama essay publishes a typical premium range of $5,000–$15,000 depending on device risk and enrollment; that is a published planning band, not a quote for your protocol.
• 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 ISO 14155 / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If Panama enrollment or the indication later needs Colombia, El Salvador, Brazil, or another bioaccess® market, a single-center MSA will not stretch.

Going direct to CEVAXIN is how you confirm a room. It is not how you open a first-in-human device investigation.

How MINSA and CNBI actually work (the short version)

Use the country pages for the full pathway.

Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national health authority sponsors meet on device investigations. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI).

Two published bioaccess® clocks, both live, both kept here as published rather than averaged into a third number:

• On Clinical Trials in Panama: ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks. Per-patient costs on that page: $12,000–$22,000. Currency is the U.S. dollar.
• On the March 2026 blog: early-feasibility is ethics-committee-driven (no separate national device-authority step of the INVIMA/ANVISA type); CNBI review timed to each committee’s meeting schedule; conservative submission-to-first-patient envelope 3–5 months including site prep and screening.

Ask for a protocol-specific calendar. Do not treat a research-center hallway estimate as MINSA clearance. bioaccess® manages the submission and keeps the reviewer relationship. That is CRO work, not site work.

All bioaccess® Panama protocols 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.

What the CRO still does after you have a CEVAXIN slide

1. Regulatory-fit, not tourism. Panama is fast and bilingual. A vaccine site network is not automatically the right room for every device indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate a CEVAXIN site only if it fits the protocol.
5. 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. See Can OUS first-in-human data support an FDA IDE submission?.

bioaccess® has been active in Panama since the early 2010s. The firm was founded in 2010. That is the operator layer around a research-center brand.

Not a critique of the research center

CEVAXIN is a serious vaccine and epidemiology resource. Five named Panama sites and a decade of public-health studies are not a punchline. This page is not a critique of that work. MINSA endorsement of vaccine and epi protocols is a real operating fact. It is still not a device-CRO quality system. Use the site when the protocol fits. Hire the operator. For the hospital-named search, stay on The Panama Clinic first-in-human. For the NCT hyphen, stay on CEVAXIN / The Panama Clinic FIH.

Colombia is still on the map

A Panama site-brand 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. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract CEVAXIN directly for a device FIH?

You can try. A research center can discuss investigator interest, local visit costs, and institutional ethics calendars. It cannot, by publishing vaccine-trial volume, become your MINSA/CNBI device applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Is CEVAXIN a CRO?

CEVAXIN publishes itself as a medical research center for clinical, epidemiological, and public-health studies. That is a site network. It is not the First-in-Human CRO for investigational devices. We do not claim CEVAXIN as a bioaccess® client.

Is this the same page as The Panama Clinic first-in-human?

No. That page is the hospital-named page. The NCT hyphen is a separate page. This is the CEVAXIN-brand page.

Next step

If the search that brought you here was CEVAXIN, start as the operator: contact bioaccess® or book from First-in-Human CRO. Hospital: The Panama Clinic first-in-human. NCT hyphen: CEVAXIN / The Panama Clinic FIH. Country: clinical trials in Panama. Sponsors at The Panama Clinic that publicly named bioaccess®: Axoft and Newrotex.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from ClinicalTrials.gov NCT06673264 (retrieved 1 September 2026), CEVAXIN public pages, published bioaccess® Panama and case-study pages, and named public press. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the facility, sponsor, and trial those sources support. We do not invent a principal investigator the NCT did not publish. We do not claim CEVAXIN as a bioaccess® client.

If you searched CEVAXIN Panama Clinic, CEVAXIN first-in-human, The Panama Clinic NCT, or “go direct to the site in Panama City,” you followed a facility string ClinicalTrials.gov actually published. Centro de Vacunación e Investigación SA (CEVAXIN) at The Panama Clinic is a real research center inside a real hospital. It is not the operator of the MINSA file.

bioaccess®’s position is simple and it is not adversarial: CEVAXIN is a site (and The Panama Clinic is the building). The First-in-Human CRO still owns MINSA/CNBI, 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 Panama is not the only fit. Sponsors who skip the CRO and email the research center still have to rebuild that stack. An NCT location row does not become a CRO.

This page is for that search. It does not repeat The Panama Clinic first-in-human (the hospital-name page) or clinical trials in Panama. Those stay the hospital page and the country operating system. This page answers the CEVAXIN / NCT query.

Why the NCT site string wins the search — and why that is not a CRO

Device registries write the facility, the city, and the sponsor. They rarely write the CRO. NCT06673264 is the clean public example.

Retrieved 1 September 2026 from ClinicalTrials.gov:

• Brief title: First-In-human Trial of a NovEl Soft and Stretchable Neural probE.
• Official title: FINESSE: First-In-Human Trial Using a NovEl Soft Neural Probe: an IDEAL StagE 1 Study.
• Lead sponsor: Axoft, Inc. (INDUSTRY). No collaborator listed. No CRO listed.
• Status: COMPLETED. Actual start 14 March 2025. Actual primary completion and completion 21 August 2025. Last update posted 18 September 2025.
• Design: interventional; phase N/A; single-group; device feasibility; no masking. Actual enrollment 5.
• Intervention, in the registry’s words: device, Soft Neural Probe — sub-acute insertion with neural signal recording during already-scheduled brain-tumor or epileptogenic-tissue resection; 30-day follow-up.
• The only location row: Centro de Vacunación e Investigación SA (CEVAXIN) – The Panama Clinic, Panama City, Panama.
• On that snapshot: no central contacts, no overall officials, no site contacts, no investigators. We will not invent a PI name to fill that blank.

That is useful public information about a completed first-in-human device study at this building. It is also how a founder googles “Panama Clinic neural probe” and lands on a vaccine-research center with no operator on the page.

The same leak exists in trade press that never touches this NCT. Medical Device Network (retrieved 23 August 2026) placed Nanochon’s Chondrograft first-in-human at The Panama Clinic, with named sports-medicine surgeons, MINSA approval, and no CRO in the copy. As of this writing, bioaccess® does not list Nanochon as a client. We cite that press for one reason: this is how a sponsor finds the hospital without finding the operator. We will not add Nanochon to a bioaccess® hospital list.

CEVAXIN is a site. The Panama Clinic is a building. The CRO is the operator.

CEVAXIN’s own about page (retrieved 1 September 2026) describes a medical research center founded in 2013 in Panama. Public claims on that page: more than ten years; +40 clinical studies; +25,000 participants; +15 national and international sponsors; more than 200 research professionals; five Panama sites, including The Panama Clinic, 24 de diciembre, and Chorrera (the same page also lists Avenida México and Chiriquí). The work it advertises is clinical, epidemiological, and public-health studies of vaccine-preventable disease — polio, dengue, RSV, zoster, norovirus, pneumococcus, hepatitis A, meningitis, pertussis, chikungunya, COVID-19 — under national ethics committees and MINSA endorsement.

That is a real vaccine and epidemiology site network. It is not a first-in-human medical-device CRO. Pediatrics, epidemiology, and tropical medicine on a staff page do not become ISO 14155 device monitoring, an investigational-device importer of record, or a 21 CFR 812.28 package because one NCT row hyphenated the legal name onto The Panama Clinic.

What a site can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing research center or a surgical service in the same building.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote procedure, bed, and local staffing costs for the cases they will physically run.

What the site is not built to own for an investigational device:

• MINSA and CNBI. The national file is not a hallway conversation with a research coordinator, and it is not an NCT location string.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages, not a site email.
• Clinical trial insurance. Required. The Panama essay publishes a typical premium range of $5,000–$15,000 depending on device risk and enrollment; that is a published planning band, not a quote for your protocol.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The hospital runs the case. The research center 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 ISO 14155 / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If Panama enrollment or the indication later needs Colombia, El Salvador, Brazil, or another bioaccess® market, a single-site MSA will not stretch.

Going direct to CEVAXIN or The Panama Clinic is how you confirm a room. It is not how you open a first-in-human device investigation.

How MINSA and CNBI actually work (the short version)

Use the country pages for the full pathway. The facts a sponsor searching this NCT needs on one screen:

Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national health authority sponsors meet on device investigations. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI).

Two published bioaccess® clocks, both live, both kept here as published rather than averaged into a third number:

• On Clinical Trials in Panama: ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks. Per-patient costs on that page: $12,000–$22,000. Currency is the U.S. dollar.
• On the March 2026 blog: early-feasibility is ethics-committee-driven (no separate national device-authority step of the INVIMA/ANVISA type); CNBI review timed to each committee’s meeting schedule; conservative submission-to-first-patient envelope 3–5 months including site prep and screening.

Ask for a protocol-specific calendar. Do not treat a research-center hallway estimate as MINSA clearance. bioaccess® manages the submission and keeps the reviewer relationship. That is CRO work, not site work.

All bioaccess® Panama protocols 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.

Which first-in-human sponsors at this building have publicly named bioaccess®?

Two named programs, already on live case-study pages. We will not add a third hospital-level claim we have not verified on a bioaccess® page. We will not pretend the NCT named the CRO; it did not.

Axoft — ultra-soft BCI at The Panama Clinic

Live case study Axoft — Panama First-in-Human: ultra-soft implantable BCI; FDA Breakthrough Device Designation (2022). Axoft has said it partnered with bioaccess® to enable the study, which ran at The Panama Clinic — four patients implanted during brain-tumor resection — inside a worldwide effort the same page reports as 11 implants, then a $55M Series A in April 2026. Ethics on that page: 4 weeks.

NCT06673264 is the public registry row for that Axoft FINESSE study: completed, actual n=5, location string CEVAXIN–The Panama Clinic, no CRO on the record. Read both sources as they are. The NCT is the search gap. We will not invent a reconciliation of 4 versus 5 beyond what each page already prints.

Newrotex — world’s first SilkAxons™ implant

Live case study Newrotex — SilkAxons™: investigational silk nerve guide. World-first SilkAxons™ implant at The Panama Clinic; FIH start August 2025; still investigational; regulatory approval on that page ~2 weeks. Newrotex has said bioaccess® was its CRO partner, managing regulatory and clinical operations.

The country page also names other Panama work. Those are Panama-country claims, not “at CEVAXIN” claims, so they stay off this list.

XCath’s Operation Robo Angel: what the public sources say about CEVAXIN

A second device first-in-human (FIH) story now runs through this building, and this time the public copy names CEVAXIN. It comes from company and network posts and trade press, not from a registry: a ClinicalTrials.gov search for XCath on 2 November 2026 returned no record, so there is no NCT row to quote here.

• The procedure: XCath reported what it calls the world’s first telerobotic stroke procedure, a remote mechanical thrombectomy done with its Iris robotic system as part of a clinical investigation named Operation Robo Angel. Neurointerventionist Dr. Vitor Mendes Pereira (University of Toronto) led it from Clínica Norte in Santiago, Panama, more than 200 km from the patient in Panama City. Local neurosurgeon Dr. Anastasio Ameijeiras Sibauste (The Panama Clinic) was with the patient (NeuroNews, 25 March 2026, reporting XCath’s release).
• CEVAXIN’s public role: Endpoints LATAM, the network CEVAXIN belongs to, wrote on 18 October 2026 that this first-in-human trial was “conducted by Cevaxin,” in collaboration with XCath Robotics and The Panama Clinic, and credited the CEVAXIN team led by Dr. Viviana Márquez (Endpoints LATAM on LinkedIn). That is a site role as the network describes it. The post does not say who held the MINSA and CNBI submissions, the import, or the monitoring.
• Supporting hospitals: the same post says the trial had the support of Hospital Santo Tomás, the Caja de Seguro Social (CSS) Complejo Hospitalario Dr. Arnulfo Arias Madrid, and Hospital Irma de Lourdes Tzanetatos. None of the sources we checked calls them trial sites, and we do not present them as trial sites.
• Since then: on 29 October 2026 XCath released a documentary, “Operation Robo Angel: Chapter One,” for World Stroke Day. The release says the Iris system received FDA Breakthrough Device Designation in September 2026, was then accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot, and remains under development (XCath via Business Wire, 29 October 2026).
• Not claimed here: that bioaccess® ran, supported, or was the CRO for Operation Robo Angel; that XCath is a bioaccess® client; that the three supporting hospitals were trial sites. None of these sources names a CRO.

The remote-console side of the same procedure has its own page: Clínica Norte, Santiago, Panama. The patient was treated at The Panama Clinic; Clínica Norte held the console.

Sources checked 2 Nov 2026. Press and network copy only; no registry record found. Not a claim that bioaccess® ran this study. General information, not legal or regulatory advice.

What the CRO still does after you have a facility string

Once CEVAXIN–The Panama Clinic is on the slide, the remaining job is the one sponsors skip when they go direct to the site:

1. Regulatory-fit, not tourism. Panama is fast and bilingual. It is not automatically the right country for every indication or every FDA plan. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate CEVAXIN, The Panama Clinic, or both only if they fit the protocol. A vaccine-research center is not automatically a neurosurgical FIH site.
5. 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. See Can OUS first-in-human data support an FDA IDE submission?.

bioaccess® has been active in Panama since the early 2010s. The firm was founded in 2010. That is the operator layer around a site string like this one.

Colombia is still on the map

A Panama Clinic 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. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract CEVAXIN or The Panama Clinic directly?

You can try. A research center can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by appearing on an NCT row, become your MINSA/CNBI applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. If the goal is a first-in-human device study, contract a first-in-human CRO, then let the CRO activate the site.

Does CEVAXIN run device first-in-human studies?

CEVAXIN publishes vaccine, epidemiology, and public-health work. One completed device NCT lists it as the location for Axoft FINESSE, and Endpoints LATAM, the network CEVAXIN belongs to, says CEVAXIN conducted XCath’s Operation Robo Angel first-in-human telerobotic thrombectomy trial with The Panama Clinic. Those are site roles, not a device-CRO product. We do not claim CEVAXIN as a bioaccess® client.

Which FIH sponsors at The Panama Clinic have publicly named bioaccess®?

Two sponsors have publicly named bioaccess® as a partner: Axoft and Newrotex. We do not add Nanochon. Nanochon’s public press places Chondrograft at The Panama Clinic; it does not make Nanochon a bioaccess® client.

Next step

If the search that brought you here was CEVAXIN or the NCT location, start as the operator: contact bioaccess® or book from First-in-Human CRO. Keep the hospital page on The Panama Clinic first-in-human and the country system on clinical trials in Panama. Sponsors at this building that publicly named bioaccess®: Axoft and Newrotex.

CEVAXIN-brand query (no hospital hyphen): CEVAXIN FIH: a vaccine research center is not the device CRO.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from the live ClinicalTrials.gov record NCT06113354 (last update posted 1 September 2026; first posted 2 November 2023) and the published bioaccess® Brazil country page, verified 1 September 2026. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the facility, investigators, and trial those sources support. Polares Medical is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Fundação Universitaria de Cardiologia clinical trial, Porto Alegre MRace, Polares Medical Brazil EFS, EXPLORE MRace BR, or “go direct to the Porto Alegre mitral site,” you followed a facility string ClinicalTrials.gov still publishes on 1 September 2026. Fundação Universitaria de Cardiologia in Porto Alegre, Rio Grande do Sul, is a real cardiology facility on that record. It is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: Fundação Universitaria de Cardiologia 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 Porto Alegre is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. A recruiting location row does not become a CRO.

This page is for the Porto Alegre query. It does not repeat clinical trials in Brazil. That page stays the country operating system. The São Paulo sister row on the same NCT already has its own page: InCor HCFMUSP. Porto Alegre is separate from InCor. PercAssist AVANXA remains a separate city-plus-KOL page with no hospital invented: PercAssist AVANXA Brazil.

Why the hospital name wins the search — and why that is not a CRO

NCT06113354 is an industry device early-feasibility listing. Brief title: EXPLORE MRace (BR): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant. Official title: Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant Brazil (EXPLORE MRace – BR). Acronym: EXPLORE MRace. Lead sponsor: Polares Medical SA, class INDUSTRY. Collaborator listed: Polares Medical, Inc. only. No CRO is listed.

Design on the 1 September 2026 snapshot: interventional; single-group registry; no masking; primary purpose DEVICE_FEASIBILITY; phase N/A; estimated enrollment 10; status RECRUITING. Actual start 8 April 2024. Study first posted 2 November 2023; last update posted 1 September 2026. Condition: mitral valve disease. Intervention, in the registry’s words: Transcatheter mitral valve repair (MRace Implant and Delivery System), other name TMVr — femoral-vein / transseptal placement of a prosthesis intended to augment the posterior mitral leaflet.

Location rows currently published:

• Fundação Universitaria de Cardiologia, Porto Alegre, Rio Grande do Sul, Brazil — RECRUITING. Site contact named as Rogerio Leite, MD. Principal investigator listed as Roberio Leite, MD (names as published on ClinicalTrials.gov; we will not invent a single merged identity or invent a hospital email beyond what the public row shows).
• InCor – Instituto do Coração do Hospital das Clínicas da FMUSP, São Paulo, Brazil — RECRUITING. Principal investigators / contacts named include Alexandre Abizaid, MD and Fabio Sandoli de Brito, MD. Already covered on InCor HCFMUSP.

Central contact on the record: Kristine Orosz, Polares Medical. Study director: Robin Eckert, Polares Medical. The brief summary still says “up to 10 patients at one (1) center in Brazil,” while the locations module lists two recruiting Brazilian facilities. We report both facts as published. We do not invent which building ran which case.

Read the record as it is. Primary purpose is DEVICE_FEASIBILITY and the title says Early Feasibility. Estimated n=10 is classic EFS scale. No CRO collaborator appears. That is the search gap: a sponsor searching MRace, Polares, or Porto Alegre cardiology now lands on a named hospital with InCor already known and Fundação Universitaria still without a dedicated public page until this page.

Porto Alegre is a site. The CRO is the operator.

A Porto Alegre cardiology foundation can provide imaging, structural-heart rooms, and an investigator the registry already named. That is necessary. It is not sufficient for an early-feasibility TMVr study a U.S. board expects to survive FDA review — including a later IDE conversation after OUS feasibility.

What a site can typically do when a sponsor “goes direct”:

• Discuss investigator interest and procedural feasibility for a mitral protocol — when that service is available and appropriate for your device, which is not automatic.
• Share institutional CEP calendars and hospital research rules.
• Quote procedure, visit, and local staffing costs for the cases they will physically run.

What the site 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 in Porto Alegre is not that dossier.
• CEP. Institutional ethics under Law 14874; published country-page cap of 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have Fundação Universitaria” still leaves the packet to write.
• Investigational import into Brazil is a separate permit from the trial authorization and from later ANVISA market registration (RDC 751/2022 / BRH). See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a Porto Alegre-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF — including if you later use the InCor row on the same NCT or add Colombia.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. If Porto Alegre enrollment, imaging, or the indication later needs São Paulo capacity already on this NCT, Bogotá, or Panama City, a single-hospital MSA will not stretch.

Going direct to Fundação Universitaria de Cardiologia is how you confirm a room. It is not how you open an investigational file.

Site versus CRO

How ANVISA and CEP sit next to the hospital

Use Clinical Trials in Brazil for the full pathway. Facts a sponsor searching this hospital needs on one screen, already published there and not re-averaged here:

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• Trial authorization and market registration are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval.
• bioaccess®’s published Brazil cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study. Headline ~40% faster / ~30% lower per-patient figures on llms.txt and LATAM FIH benchmarks 2026 are the same class of estimate.

We will not invent a Fundação Universitaria-only day-count. Ask for a protocol-specific calendar. A hospital email is not an ANVISA approval.

What the Polares public file actually supports — and what it does not

• Device: MRace Implant and Delivery System (TMVr / posterior leaflet restoration), as described on NCT06113354.
• Sponsor: Polares Medical SA (industry). Collaborator: Polares Medical, Inc. No CRO named.
• Sites: Fundação Universitaria de Cardiologia, Porto Alegre (this page); InCor HCFMUSP, São Paulo (existing page).
• Design: interventional DEVICE_FEASIBILITY early feasibility; estimated n=10; actual start 8 April 2024; RECRUITING on the 1 September 2026 last-update snapshot.
• Named investigators (as published): Rogerio Leite, MD (Porto Alegre contact); Roberio Leite, MD (Porto Alegre PI listing); Alexandre Abizaid, MD and Fabio Sandoli de Brito, MD (InCor).
• Not claimed here: that the NCT named bioaccess®; that Polares Medical is a bioaccess® client; that we have Polares outcomes; that the brief summary’s “one center” line erases the second location row; that Porto Alegre is the same building as InCor, Dante Pazzanese, or PercAssist AVANXA.

Sister São Paulo pages stay on their own buildings: InCor and Instituto Dante Pazzanese. They are separate from Porto Alegre.

What the CRO still does after you have a hospital name

• Regulatory-fit, not tourism. Brazil is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the ANVISA / CEP packet.
• Importer of record and device accountability across Porto Alegre and, if used, the InCor row.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality if one Rio Grande do Sul room is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract Fundação Universitaria de Cardiologia directly?

You can try. The facility can discuss investigator interest, local procedure costs, and CEP calendars. It cannot become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Polares listed Porto Alegre. Contract the CRO; let the CRO activate the site.

Did bioaccess® run EXPLORE MRace / Polares in Brazil?

No public bioaccess® page says so. We will not invent that claim. This page answers the search; it does not claim the study.

InCor is on the same NCT. Why a separate Porto Alegre page?

Because sponsors search the facility string they see. InCor already has InCor HCFMUSP. Fundação Universitaria de Cardiologia is a different building in a different city. Linking is correct. Duplicating the InCor page is not.

If I already have Porto Alegre, what does the CRO still do?

Regulatory-fit (Brazil vs Colombia vs a multi-site Brazil design that already includes InCor on this NCT); the ANVISA / CEP packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one Porto Alegre room is not enough.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Porto Alegre EFS search is not an instruction to abandon INVIMA.