Category: Preparing for First-In-Human Studies

Figures cited from named public press (CereVasc IR and matching trade items retrieved 1 September 2026) and the published bioaccess® Argentina country page. Press mention_n is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANMAT, ethics, provincial, and FDA rules with qualified advisers. We name only the facility, PI, and sponsor those sources support. We do not invent a CRO the wires did not name. We do not claim Clínica la Sagrada Familia, ENERI, or CereVasc as a bioaccess® client.

If you searched Clínica la Sagrada Familia first-in-human, ENERI Buenos Aires CRO, Pedro Lylyk eShunt, or “go direct Sagrada Familia Argentina,” you followed a hospital name that is genuinely in the public file. Clínica la Sagrada Familia (ENERI) in Buenos Aires is a real neuroendovascular site. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns ANMAT, independent ethics, provincial oversight, 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 Buenos Aires is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A press release that names the building does not become a CRO.

This page is the intercept for the Buenos Aires press cluster. It does not clone Hospital Italiano Asunción FIH (CMS 95517 — Paraguay, DINAVISA, a different building). It is also not Hospital Italiano de Buenos Aires (HIBA; a different NCT campus string). Linking is correct. Merging Asunción, HIBA, and Sagrada Familia is not.

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

Device press writes the implant, the city, the hospital, and the surgeon. It rarely writes the CRO. On the 1 September 2026 LATAM device FIH/EFS press sweep, Clínica la Sagrada Familia (ENERI), Buenos Aires, Argentina, is rank 3, mention_n=8. Example URLs the ranking actually used:

• CereVasc IR, 10 February 2021 — first patient in a study of the investigational eShunt™ System for communicating hydrocephalus. Site: Clinica Sagrada Familia. PI named: Dr. Pedro Lylyk. Trial name: ETCHES I. No CRO.
• CereVasc IR, 7 December 2021 and the matching Endovascular Today item — FIH case report; Clinica la Sagrada Familia; Lylyk named. No CRO.
• PR Newswire, 30 July 2025 — 100th eShunt patient (pilot plus STRIDE), treated by Dr. Pedro Lylyk at Clinica la Sagrada Familia. The release names him CEO of ENERI and Clinica la Sagrada Familia and co-lead investigator of STRIDE. No CRO.
• CereVasc IR, 21 January 2026 plus Endovascular Today and NeuroNews rewrites — ETCHES enrollment complete; Clinica la Sagrada Familia; Lylyk named. No CRO.

That is useful public information about a press-named Buenos Aires FIH site. It is how a founder googles “Lylyk eShunt” or “Sagrada Familia first-in-human” and lands on a clinic without landing on ANMAT, importer of record, ISO 14155, or 21 CFR 812.28. We cite those URLs as facility evidence. We will not invent a CRO. We will not claim bioaccess® ran ETCHES I, STRIDE, or any CereVasc program. No live bioaccess® case-study page names this clinic as a client site.

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

A Buenos Aires neuroendovascular clinic can provide rooms, imaging, coordinators, and an investigator the sponsor already put in the wire. 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 neuroendovascular service.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

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

• ANMAT. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica. The published Argentina hub puts a 90-business-day statutory review target on submitted clinical-trial documents; the clock pauses for RFIs, and FIH/EFS device studies often exceed that target. A hallway conversation in Recoleta is not that dossier.
• Independent ethics plus provincial oversight (Buenos Aires). Those packages sit alongside the federal file. Sequential filing adds time.
• Investigational import into Argentina 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 Sagrada Familia-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The clinic may run the case. 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 Buenos Aires enrollment or the indication later needs Colombia, Paraguay, or Panama, a single-clinic MSA will not stretch.

Going direct to Clínica la Sagrada Familia is how you confirm a room. It is not how you open an investigational file.

Site versus CRO

Workstream	What Sagrada Familia / ENERI (site) typically owns	What the CRO still owns
Procedure	Rooms, imaging, neuroendovascular service, local staff	Protocol fit, training, device accountability
Ethics	Institutional / independent committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing in a CereVasc IR	ANMAT clinical-trial authorization (90-business-day statutory target; clock pauses apply)
Provincial	Local Buenos Aires research rules if they apply to the host	Provincial filings in parallel with the federal file
Import	Receiving and storage if contracted	Importer of record
Quality	Clinic quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One Buenos Aires clinic	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANMAT actually works (the short version)

Use clinical-trials-argentina for the full pathway. Facts a sponsor searching this clinic needs on one screen, already published there and not re-averaged here:

• ANMAT is the national authority for medicines, medical devices, and clinical research.
• Statutory review target: 90 business days. The clock pauses for agency queries. FIH/EFS device studies commonly exceed the target. Treat it as a planning framework, not a guaranteed start.
• Independent ethics committee approval under ISO 14155, plus provincial oversight (e.g., Buenos Aires).
• Headline ~30% lower per-patient cost versus typical US/EU programs is experience since 2010, not a formal study. ANMAT device registration is a second, separate file. This site does not publish ANMAT as PAHO/WHO Level 4.
• Under 21 CFR 812.28, foreign clinical data from Argentina is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANMAT authorization and ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A clinic email is not an ANMAT approval. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® Argentina 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.

Do not smear the clinic — and do not merge Buenos Aires with Asunción

Clínica la Sagrada Familia and ENERI are a serious neuroendovascular resource. Eight independent press URLs naming the building is a signal of public visibility, not a punchline. This page is not a critique of that work. Visibility in CereVasc copy is still not a device-CRO quality system. Use the site when the protocol fits. Hire the operator.

Do not merge this clinic into Hospital Italiano de Buenos Aires. Do not merge it into Hospital Italiano / Sanatorio Italiano, Asunción. Different countries. Different regulators (ANMAT vs DINAVISA). Different investigators in the public file.

What the CRO still does after you have a Sagrada Familia slide

1. Regulatory-fit, not tourism. Argentina is a sourced device geography. One Buenos Aires clinic 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 ANMAT / ethics / provincial 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 Sagrada Familia / ENERI 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 press-named clinic.

Colombia is still on the map

A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Clínica la Sagrada Familia or ENERI directly for a device FIH?

You can try. The clinic can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by appearing in eight CereVasc URLs, become your ANMAT 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 eShunt / ETCHES I / STRIDE work named here?

No public bioaccess® case-study page names this clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies. mention_n=8 is a press-URL count, not bioaccess® enrollment.

Is this the same hospital as Hospital Italiano de Buenos Aires or Hospital Italiano Asunción?

No. HIBA is a different Buenos Aires campus (NCT intercept, not this press cluster). Hospital Italiano Asunción is Paraguay. Do not merge them.

If I already have Dr. Lylyk, what does the CRO still do?

Regulatory-fit (Argentina vs Colombia vs a multi-country design); the ANMAT / ethics / provincial packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one Buenos Aires room is not enough. A named PI is the site. He is not the CRO.

Next step

If the search that brought you here was Clínica la Sagrada Familia, ENERI, or Pedro Lylyk, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Argentina. Distinct Paraguay hospital: Hospital Italiano Asunción.

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 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 INVIMA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital Pablo Tobón Uribe as a bioaccess® client.

If you searched Hospital Pablo Tobon Uribe first-in-human, HPTU Medellín clinical trial, Pablo Tobón Uribe CRO, or “go direct Hospital Pablo Tobón Uribe,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Pablo Tobón Uribe in Medellín is a real private hospital. It is not a first-in-human medical-device CRO, and it is not the operator of the INVIMA file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns INVIMA, institutional ethics / CEI, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the Medellín campus intercept. It does not clone Fundación Santa Fe de Bogotá. Bogotá is a different city and a different NCT string.

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

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

• Hospital Pablo Tobon Uribe (Medellín, Colombia): ALL interventional n=62 (rank 10). Example NCT IDs: NCT00096421, NCT00261846, NCT00389519.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

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

A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

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

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

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

• INVIMA. INVIMA is the national file for an investigational device in Colombia. Resolución 8430/1993 still sits on the ethics and research side of that stack. A hallway conversation in El Poblado is not the INVIMA dossier. Resolución 2378 does not govern device clinical trials — see the live country pages rather than importing a drug-GCP resolution onto a device FIH.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How INVIMA actually works (the short version)

Use CRO in Colombia. Published comparison already on the Panama country page: Colombia ethics typically 4–6 weeks; per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country.

Ask for a protocol-specific calendar. A hospital email is not INVIMA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Do not smear the hospital

Hospital Pablo Tobón Uribe is a serious Medellín resource. n=62 is registry volume. It is not a device-CRO quality system. Do not merge it into Santa Fe Bogotá.

What the CRO still does after you have the campus on a slide

1. 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.
2. Protocol, IB, ICF, insurance, and the INVIMA / ethics 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 this campus 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. 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 Hospital Pablo Tobón Uribe directly for a device FIH?

You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your INVIMA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as Fundación Santa Fe de Bogotá?

No. Santa Fe is the Bogotá intercept. This page is Medellín only.

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. Colombia: CRO in Colombia. Santa Fe sibling: Fundación Santa Fe de Bogotá FIH.

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 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 COFEPRIS, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim INCMNSZ Salvador Zubirán as a bioaccess® client.

If you searched INCMNSZ first-in-human, Salvador Zubiran clinical trial, Instituto Nacional de Ciencias Medicas y Nutricion CRO, or “go direct INCMNSZ Salvador Zubirán,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) in Mexico City is a real national institute. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns COFEPRIS, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page merges two NCT spellings of one campus: unaccented Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran and accented Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. It does not clone CODET Vision Institute Tijuana. Tijuana is a different building and a different query.

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

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

• Unaccented string (Mexico City, Mexico): ALL interventional n=66 (rank 9). Example NCT IDs: NCT00162643, NCT00413699, NCT00517738.
• Accented string: ALL n=44 (rank 29).

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

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

A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

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

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

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

• COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation in Tlalpan is not that file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How COFEPRIS actually works (the short version)

Use clinical-trials-mexico and CRO in Mexico. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

Ask for a protocol-specific calendar. A hospital email is not COFEPRIS clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Do not smear the hospital

INCMNSZ is a serious national institute. Registry volume is not a punchline. Do not merge it into CODET Tijuana.

What the CRO still does after you have the campus on a slide

1. 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.
2. Protocol, IB, ICF, insurance, and the COFEPRIS / ethics 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 this campus 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. 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 INCMNSZ Salvador Zubirán directly for a device FIH?

You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as CODET Tijuana?

No. CODET is the Tijuana ophthalmic intercept. This page is INCMNSZ in Mexico City.

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. Mexico hub: clinical trials in Mexico. CODET sibling: CODET Vision Tijuana FIH.

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 published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital Moinhos de Vento as a bioaccess® client.

If you searched Hospital Moinhos de Vento first-in-human, Moinhos de Vento Porto Alegre clinical trial, or “go direct Hospital Moinhos de Vento,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Moinhos de Vento in Porto Alegre is a real private 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 this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the Moinhos campus intercept. It does not clone Hospital de Clínicas de Porto Alegre (CMS 95615) or Fundação Universitaria de Cardiologia (CMS 95612). Three Porto Alegre buildings. Three queries.

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

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

• Hospital Moinhos de Vento (Porto Alegre, Brazil): ALL interventional n=98 (rank 5); DEVICE n=5 (rank 39). Example NCT IDs: NCT03540589, NCT04176445, NCT04660344.
• The ALL ranking flagged “CRO often” on collaborator tokens for this string. That is a registry collaborator flag, not a named CRO we will invent, and not proof the hospital is your FIH operator for a new device file.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

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

A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023. A hallway conversation in Moinhos is not that dossier.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks; CEPs capped at 30 business days; per-patient $20,000–$35,000 as published there.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Do not smear the hospital

Moinhos de Vento is a serious hospital. Registry volume is not a punchline. Do not merge it into HCPA or FUC.

What the CRO still does after you have the campus on a slide

1. 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.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics 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 this campus 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. 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 Hospital Moinhos de Vento directly for a device FIH?

You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your 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 intercepts the search; it does not claim the studies.

Is this the same page as HCPA or FUC Porto Alegre?

No. HCPA is CMS 95615. FUC is CMS 95612. This page is Moinhos only.

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. Porto Alegre siblings: HCPA, FUC.

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 published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital Israelita Albert Einstein as a bioaccess® client.

If you searched Hospital Israelita Albert Einstein first-in-human, Albert Einstein São Paulo clinical trial, Einstein CRO Brazil, or “go direct Hospital Israelita Albert Einstein,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Israelita Albert Einstein in São Paulo is a real private 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 this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the Einstein campus intercept. It does not clone InCor HCFMUSP (CMS 95522) or Dante Pazzanese. Different buildings. Different NCT strings.

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

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

• Hospital Israelita Albert Einstein (São Paulo, Brazil): ALL interventional n=100 (rank 4). Example NCT IDs: NCT00026338, NCT00040183, NCT00102752.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

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

A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation in Morumbi is not that dossier.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Do not smear the hospital

Albert Einstein is a serious clinical resource. n=100 on the ALL list is registry volume. It is not a device-CRO quality system. Do not merge Einstein into InCor or Dante.

What the CRO still does after you have the campus on a slide

1. 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.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics 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 this campus 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. 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 Hospital Israelita Albert Einstein directly for a device FIH?

You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your 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 intercepts the search; it does not claim the studies.

Is this the same page as InCor or Dante Pazzanese?

No. Those are separate São Paulo intercepts already live. This page is Einstein only.

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. São Paulo siblings: InCor, University of Sao Paulo. 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 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 ANMAT, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital Italiano de Buenos Aires as a bioaccess® client.

If you searched Hospital Italiano de Buenos Aires first-in-human, Hospital Italiano Buenos Aires clinical trial, HIBA CRO, or “go direct Hospital Italiano de Buenos Aires,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Italiano de Buenos Aires is a real private university hospital in Buenos Aires, Argentina. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ANMAT, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the Buenos Aires campus intercept. It does not clone Hospital Italiano Asunción FIH (CMS 95517). Asunción is a different country, a different regulator (DINAVISA), and a different NCT string family (Sanatorio Italiano / Italian Hospital, Asunción). Linking is correct. Collapsing the aliases 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 studies; all years; complete dump), this campus sits here after filters:

• Hospital Italiano de Buenos Aires (Buenos Aires, Argentina): DEVICE n=10 (rank 11 on the DEVICE list). Example NCT IDs: NCT00932438, NCT02099721, NCT02724540.
• ALL interventional: n=133 (rank 3 on the ALL list).

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

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

A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation in Recoleta is not that file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANMAT actually works (the short version)

Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.

Ask for a protocol-specific calendar. A hospital email is not ANMAT clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Do not smear the hospital

Hospital Italiano de Buenos Aires is a serious academic resource. Ranking high on a public ALL-interventional facility list is registry volume, not a punchline. Use the site when the protocol fits. Hire the operator. Keep Asunción on its own page.

What the CRO still does after you have the campus on a slide

1. 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.
2. Protocol, IB, ICF, insurance, and the ANMAT / ethics 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 this campus 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. 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 Hospital Italiano de Buenos Aires directly for a device FIH?

You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANMAT applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as Hospital Italiano Asunción?

No. Asunción is CMS 95517. This page is Buenos Aires only.

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. Asunción sibling: Hospital Italiano Asunción FIH.

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 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 slug: Universidade Nove de Julho, University of Nove de Julho, and Nove de Julho University. It does not clone 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

Workstream	What Nove de Julho (site) typically owns	What the CRO still owns
Procedure	Labs, rooms, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional CEP calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation dossier (RDC 837/2023)
Import	Receiving and storage if contracted	Importer of record
Quality	University quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One São Paulo university (three NCT spellings)	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA and CEP actually work (the short version)

Use clinical-trials-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.

Do not smear 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.

Do not merge this campus into 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. 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 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 slug. 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 the intercept for the NCT campus string Universidade Federal de Pernambuco. It does not clone São Paulo intercepts already live (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

Workstream	What UFPE (site) typically owns	What the CRO still owns
Procedure	Labs, rooms, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional CEP calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation dossier (RDC 837/2023)
Import	Receiving and storage if contracted	Importer of record
Quality	University quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One Recife campus	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA and CEP actually work (the short version)

Use clinical-trials-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.

Do not smear 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. Do not merge Recife into 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. 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 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 intercepts 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 published bioaccess® Panama 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 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 the intercept 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 intercepted). It does not clone the live MINIject / STAR-I intercept Panama Eye Centre / Orillac-Calvo MINIject (CMS 95530). That page is a different query: NCT03193736 STAR-I and the British Journal of Ophthalmology site name. Link it. Do not copy it. 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 intercept 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.

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 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. 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

Workstream	What Panama Eye Center (site) typically owns	What the CRO still owns
Procedure	OR, imaging, ophthalmic service, local staff	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB, CNBI-registered process
National authority	Not the permit holder by appearing on an NCT	MINSA / CNBI
Import	Receiving and storage if contracted	Importer of record
Quality	Clinic quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One Panama City NCT string	Colombia (INVIMA) and the rest of the bioaccess® platform

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-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 often 4–8 weeks; conservative submission-to-first-patient envelope 3–5 months including site prep and screening.

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.

Do not clone the STAR-I page — and do not smear 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. 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 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 intercept is CMS 95530 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 intercept: InCor HCFMUSP (CMS 95522). Link that page. Do not clone it. “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

Workstream	What the USP campus string (site) typically owns	What the CRO still owns
Procedure	Rooms, labs, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional CEP calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation dossier (RDC 837/2023)
Import	Receiving and storage if contracted	Importer of record
Quality	University quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One NCT spelling in São Paulo	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA and CEP actually work (the short version)

Use clinical-trials-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-hcfmosp-fih. 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 intercept. Do not smear 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. 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 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 live at incor-hcfmosp-fih. 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®