Author: Julio Martinez-Clark

Figures cited from a ClinicalTrials.gov API v2 facility pull (25 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Bauru School of Dentistry as a bioaccess® client.

If you searched Bauru School of Dentistry first-in-human, Bauru School of Dentistry USP clinical trial, dental school Bauru device study, or “go direct Bauru School of Dentistry,” you followed a campus string ClinicalTrials.gov still publishes. Bauru School of Dentistry, a University of São Paulo (USP) school campus in Bauru, Brazil, is a real named school-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the dental school is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the dental school still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Bauru dental-school campus. It is DISTINCT from the University of São Paulo university-string page, Hospital das Clínicas of the University of São Paulo Medical School (FMUSP;), and EACH-USP — all in the city of São Paulo, not Bauru. A separate registry spelling, “Bauru Dental School, University of São Paulo,” is not added to this count. Sharing a university system is not a license to collapse a different city campus into it.

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

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 25 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 25 September 2026 for the facility strings listed below, restricted to locations in Bauru, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Bauru School of Dentistry (Bauru, Brazil) — registry strings counted: “Bauru School of Dentistry”; “Bauru School of Dentistry – University of Sao Paulo”; “Bauru School of Dentistry/USP”. ALL studies n=18; interventional n=15; DEVICE n=5. Example NCT IDs: NCT02938988, NCT03232788, NCT03251001.

The three spellings above are counted once per NCT ID for Bauru locations; 3 of the 18 are observational. We do not combine the separate “Bauru Dental School” spelling.

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 dental school as a client site.

That is the leak: a founder searching Bauru School of Dentistry finds ALL n=18 (DEVICE n=5) without finding ANVISA. A named dental-school campus is still a site. An NCT location row is not a CRO.

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

A named dental school 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 dental school 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 dental school is not built to own for an investigational device:

• ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at the Bauru dental school is not a University of São Paulo university-string file and is not an ANVISA file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the school

Bauru School of Dentistry is a serious named Brazilian school campus on the public registry. ALL n=18 and DEVICE n=5 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (HDE) — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. 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 Bauru School of Dentistry directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as University of São Paulo?

No. University of Sao Paulo is the São Paulo university-string page. This page is the Bauru dental-school campus only.

Did bioaccess® run NCT02938988?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. University-system sibling (do not merge): University of São Paulo.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov API v2 facility pull (25 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim PROCAPE Recife as a bioaccess® client.

If you searched PROCAPE Recife first-in-human, Pronto Socorro Cardiologico de Pernambuco clinical trial, PROCAPE device study, or “go direct PROCAPE Recife,” you followed a campus string ClinicalTrials.gov still publishes. Pronto Socorro Cardiológico de Pernambuco (PROCAPE, a cardiology emergency and referral hospital) in Recife, Brazil, is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Recife PROCAPE campus. It is DISTINCT from the UFPE (Universidade Federal de Pernambuco) Recife page, the Universidade Federal de Pernambuco page, IMIP (Instituto de Medicina Integral Prof. Fernando Figueira) Recife, Hospital Agamenon Magalhães Recife, Hospital do Câncer de Pernambuco Recife, Real Hospital Português Recife, and the Applied Neuroscience Laboratory. Sharing Recife is not a license to collapse them. PROCAPE is not UFPE. PROCAPE is not Real Hospital Português.

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

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 25 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 25 September 2026 for the facility strings listed below, restricted to locations in Recife, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Pronto Socorro Cardiológico de Pernambuco (PROCAPE) (Recife, Brazil) — registry strings counted: “Pronto Socorro Cardiológico de Pernambuco (PROCAPE)”; “Pronto Socorro Cardiológico de Pernambuco – Procape”; “Pronto Socorro Cardiologico de Pernambuco”. ALL studies n=7; interventional n=7; DEVICE n=3. Example NCT IDs: NCT01128816, NCT02270658, NCT02737215.

Aliases are counted once per NCT ID for Recife locations.

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.

That is the leak: a founder searching PROCAPE in Recife finds ALL n=7 (DEVICE n=3) without finding ANVISA. A named hospital campus is still a site. An NCT location row is not a CRO.

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

A named 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 ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at PROCAPE is not a Real Hospital Português file and is not a UFPE file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the hospital

PROCAPE is a serious named Recife campus on the public registry. ALL n=7 and DEVICE n=3 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (HDE) — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics timing in Panama and Colombia follows 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 PROCAPE Recife 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, insurance coordinator, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Real Hospital Português Recife or UFPE Recife?

No. Real Hospital Português de Beneficência em Pernambuco Recife and UFPE Recife are distinct Recife pages already published. This page is PROCAPE only.

Did bioaccess® run NCT01128816?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Recife sibling (do not merge): Real Hospital Português Recife.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov API v2 facility pull (25 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim EACH-USP São Paulo as a bioaccess® client.

If you searched Escola de Artes Ciencias e Humanidades USP first-in-human, EACH USP clinical trial, EACH USP São Paulo device study, or “go direct EACH-USP São Paulo,” you followed a campus string ClinicalTrials.gov still publishes. The Escola de Artes, Ciências e Humanidades of the Universidade de São Paulo (EACH-USP, the University of São Paulo’s School of Arts, Sciences and Humanities) in São Paulo, Brazil, is a real named school-campus string on ClinicalTrials.gov. The registry spells it “Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo.” It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the school campus is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the school campus still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named EACH-USP school-campus string. It is DISTINCT from the University of São Paulo university-string page, Hospital das Clínicas of the University of São Paulo Medical School (FMUSP;), InCor (the Heart Institute of that hospital complex), and Bauru School of Dentistry (a different USP campus in a different city). Sharing a university system is not a license to collapse them.

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

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 25 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 25 September 2026 for the facility strings listed below, restricted to locations in São Paulo, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo (São Paulo, Brazil) — registry strings counted: “Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo”. ALL studies n=8; interventional n=7; DEVICE n=5. Example NCT IDs: NCT02891434, NCT03113630, NCT03173989.

1 of the 8 is observational. None of these NCT IDs is cited on the University of São Paulo page.

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 school campus as a client site.

That is the leak: a founder searching EACH-USP finds ALL n=8 (DEVICE n=5) without finding ANVISA. A named school campus is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at EACH-USP is not a University of São Paulo university-string file and is not a Hospital das Clínicas file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the school

EACH-USP is a serious named São Paulo school campus on the public registry. ALL n=8 and DEVICE n=5 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (HDE) — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics timing in Panama and Colombia follows 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 EACH-USP São Paulo directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as University of São Paulo?

No. University of Sao Paulo is the university-string page and is already published. This page is the EACH-USP school-campus string only.

Did bioaccess® run NCT02891434?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. São Paulo sibling (do not merge): University of São Paulo.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov API v2 facility pull (25 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Colombia’s National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Angiografía de Occidente Cali as a bioaccess® client.

If you searched Angiografia de Occidente Cali first-in-human, Angiografia de Occidente clinical trial, Angiografia de Occidente device study, or “go direct Angiografía de Occidente Cali,” you followed a campus string ClinicalTrials.gov still publishes. Angiografía de Occidente in Cali, Colombia, is a real named clinic string on ClinicalTrials.gov, registered under several spellings (including Angiografía Clínica de Occidente). It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the INVIMA file.

bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns INVIMA, accredited ethics, investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Cali Angiografía de Occidente campus. It is DISTINCT from Centro Médico Imbanaco Cali, from Fundación Valle del Lili Cali, and from Centro de Investigación Médica de Occidente in Zapopan, Mexico. Sharing Cali or the word Occidente is not a license to collapse them.

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

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 25 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 25 September 2026 for the facility strings listed below, restricted to locations in Cali, Colombia. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Angiografia de Occidente, S.A. (Cali, Colombia) — registry strings counted: “Angiografia de Occidente, S.A.”; “Angiografia De Occidente S.A.”; “Angiografia de Occidente”; “Angiografia Clinica de Occidente”. ALL studies n=11; interventional n=7; DEVICE n=7. Example NCT IDs: NCT01775410, NCT01960647, NCT02006069.

Aliases are counted once per NCT ID for Cali locations; 4 of the 11 are observational, and all 7 interventional registrations list a DEVICE intervention.

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

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

That is the leak: a founder searching Angiografía de Occidente in Cali finds ALL n=11 (DEVICE n=7) without finding INVIMA. A named clinic is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• 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 on this campus is not the INVIMA dossier. Resolución 2378 does not govern device clinical trials — see the live country pages rather than importing a drug good clinical practice (GCP) resolution onto a device file. A hallway conversation at Angiografía de Occidente is not an Imbanaco file and is not a Valle del Lili file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How INVIMA actually works (the short version)

Use CRO in Colombia. Colombia ethics timing depends on each committee’s meeting schedule. Published comparison already on the Panama country page: per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email in Cali is not INVIMA clearance.

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 outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

Not a critique of the clinic

Angiografía de Occidente is a serious named Cali campus on the public registry. ALL n=11 and DEVICE n=7 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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, investigator’s brochure (IB), informed consent form (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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (HDE) — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. 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 Angiografía de Occidente Cali directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Centro Médico Imbanaco or Fundación Valle del Lili?

No. Centro Médico Imbanaco Cali and Fundación Valle del Lili Cali are already published. This page is Angiografía de Occidente Cali only.

Did bioaccess® run NCT01775410?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Cali sibling (do not merge): Centro Médico Imbanaco Cali.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov API v2 facility pull (25 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Piracicaba Dental School as a bioaccess® client.

If you searched Piracicaba Dental School first-in-human, Piracicaba Dental School Unicamp clinical trial, dental school Piracicaba device study, or “go direct Piracicaba Dental School,” you followed a campus string ClinicalTrials.gov still publishes. Piracicaba Dental School, a school campus of the State University of Campinas (Unicamp) in Piracicaba, Brazil, is a real named school-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the dental school is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the dental school still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Piracicaba dental-school campus. It is DISTINCT from the University of Campinas page and the Unicamp Campinas page, both in Campinas, and from Universidade Metodista de Piracicaba (a different institution in the same city, not paged here). The University of Campinas page already states that Piracicaba Dental School is not that page. Sharing a university system is not a license to collapse a different city campus into it.

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

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 25 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 25 September 2026 for the facility strings listed below, restricted to locations in Piracicaba, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Piracicaba Dental School, State University of Campinas (Piracicaba, Brazil) — registry strings counted: “Piracicaba Dental School, State University of Campinas”; “Piracicaba Dental School”; “Piracicaba Dental School – UNICAMP”; “Piracicaba Dental School, University of Campinas”. ALL studies n=29; interventional n=27; DEVICE n=7. Example NCT IDs: NCT02242500, NCT02456337, NCT02459704.

Aliases are counted once per NCT ID for Piracicaba locations; 2 of the 29 are observational. We do not add the Campinas university counts to this number.

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 dental school as a client site.

That is the leak: a founder searching Piracicaba Dental School finds ALL n=29 (DEVICE n=7) without finding ANVISA. A named dental-school campus is still a site. An NCT location row is not a CRO.

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

A named dental school 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 dental school 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 dental school is not built to own for an investigational device:

• ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at the Piracicaba dental school is not a Unicamp Campinas file and is not an ANVISA file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the school

Piracicaba Dental School is a serious named Brazilian school campus on the public registry. ALL n=29 and DEVICE n=7 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (HDE) — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. 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 Piracicaba Dental School directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as University of Campinas or Unicamp Campinas?

No. University of Campinas and Unicamp Campinas are the Campinas university-string pages. This page is the Piracicaba dental-school campus only.

Did bioaccess® run NCT02242500?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. University-system sibling (do not merge): University of Campinas.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov API v2 facility pull (25 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Applied Neuroscience Laboratory Recife as a bioaccess® client.

If you searched Applied Neuroscience Laboratory Recife first-in-human, LANA Recife clinical trial, Applied Neuroscience Laboratory UFPE device study, or “go direct Applied Neuroscience Laboratory Recife,” you followed a campus string ClinicalTrials.gov still publishes. The Applied Neuroscience Laboratory (registered under several spellings, including Applied Neuroscience Laboratory-LANA) in Recife, Brazil, is a real named research-laboratory string on ClinicalTrials.gov. On the public records, the lead sponsor field reads Universidade Federal de Pernambuco (UFPE, the Federal University of Pernambuco). It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the laboratory is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the laboratory still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Recife Applied Neuroscience Laboratory string. It is DISTINCT from the UFPE Recife page, the Universidade Federal de Pernambuco page, IMIP (Instituto de Medicina Integral Prof. Fernando Figueira) Recife, Real Hospital Português Recife, and Pronto Socorro Cardiológico de Pernambuco (PROCAPE). Sharing Recife or a university sponsor is not a license to collapse them. The laboratory string is not the university string.

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

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 25 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 25 September 2026 for the facility strings listed below, restricted to locations in Recife, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Applied Neuroscience Laboratory (Recife, Brazil) — registry strings counted: “Applied Neuroscience Laboratory”; “Applied Neuroscience Laboratory, Universidade Federal de Pernambuco”; “Applied Neuroscience Laboratory-LANA”; “Federal University of Pernambuco, Applied Neuroscience Laboratory”. ALL studies n=23; interventional n=20; DEVICE n=17. Example NCT IDs: NCT01875536, NCT01877148, NCT01886274.

The four spellings above are counted once per NCT ID for Recife locations; 3 of the 23 are observational. None of these NCT IDs is cited on the UFPE university pages.

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 laboratory as a client site.

That is the leak: a founder searching the Applied Neuroscience Laboratory in Recife finds ALL n=23 (DEVICE n=17) without finding ANVISA. A named research laboratory is still a site. An NCT location row is not a CRO.

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

A named laboratory 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 laboratory 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 laboratory is not built to own for an investigational device:

• ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation in this laboratory is not a UFPE university file and is not a PROCAPE file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the laboratory

The Applied Neuroscience Laboratory is a serious named Recife research string on the public registry. ALL n=23 and DEVICE n=17 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (HDE) — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics timing in Panama and Colombia follows 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 Applied Neuroscience Laboratory Recife directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as UFPE Recife or Universidade Federal de Pernambuco?

No. UFPE Recife and Universidade Federal de Pernambuco are university-string pages already published. This page is the named Applied Neuroscience Laboratory string only.

Did bioaccess® run NCT01875536?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Recife sibling (do not merge): UFPE Recife.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov API v2 facility pull (25 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Laboratory of Phototherapy and Innovative Technologies in Health São Paulo as a bioaccess® client.

If you searched Laboratory of Phototherapy and Innovative Technologies in Health first-in-human, phototherapy laboratory São Paulo clinical trial, Laboratory of Phototherapy São Paulo device study, or “go direct Laboratory of Phototherapy and Innovative Technologies in Health São Paulo,” you followed a campus string ClinicalTrials.gov still publishes. The Laboratory of Phototherapy and Innovative Technologies in Health in São Paulo, Brazil, is a real named research-laboratory string on ClinicalTrials.gov. On the public records for these registrations, the lead sponsor field reads University of Nove de Julho. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the laboratory is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the laboratory still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named São Paulo phototherapy laboratory string. It is DISTINCT from the Universidade Nove de Julho university-string page, from the University of São Paulo page, and from the other São Paulo campus pages already published. Sharing a sponsor field or a city is not a license to collapse them. The laboratory string is not the university string, and neither one is a CRO.

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

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 25 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 25 September 2026 for the facility strings listed below, restricted to locations in São Paulo, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Laboratory of Phototherapy and Innovative Technologies in Health (São Paulo, Brazil) — registry strings counted: “Laboratory of Phototherapy and Innovative Technologies in Health”. ALL studies n=14; interventional n=14; DEVICE n=14. Example NCT IDs: NCT03803956, NCT03858179, NCT03879226.

Every one of the 14 is an interventional DEVICE registration on the public record. None of these NCT IDs is cited on the Universidade Nove de Julho page.

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 laboratory as a client site.

That is the leak: a founder searching the Laboratory of Phototherapy in São Paulo finds ALL n=14 (DEVICE n=14) without finding ANVISA. A named research laboratory is still a site. An NCT location row is not a CRO.

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

A named laboratory 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 laboratory 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 laboratory is not built to own for an investigational device:

• ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation in this laboratory is not a Universidade Nove de Julho university file and is not an ANVISA file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the laboratory

The Laboratory of Phototherapy and Innovative Technologies in Health is a serious named São Paulo research string on the public registry. ALL n=14 and DEVICE n=14 are registry volume, not a punchline. This page is not a critique of phototherapy research. Use the site when the protocol fits. Hire the operator.

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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (HDE) — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. 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 Laboratory of Phototherapy and Innovative Technologies in Health São Paulo directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Universidade Nove de Julho?

No. Universidade Nove de Julho is the university-string page and is already published. This page is the named phototherapy laboratory string only, with its own NCT IDs.

Did bioaccess® run NCT03803956?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. São Paulo sibling (do not merge): Universidade Nove de Julho.

Julio G. Martinez-Clark, CEO · bioaccess®

On a limited budget, the best contract research organization (CRO) for an early-phase trial is one whose model is sized for a single small study: pricing built from your schedule of events, pass-through costs you can audit, and a country plan that lowers site costs and start-up time without weakening the data package. For medical device first-in-human (FIH) and early feasibility studies (EFS), bioaccess® publishes sample first-in-human budgets of about $430K for a 20-subject minimally invasive device study and about $1.32M for a 10-subject surgical implant study (illustrative, not a quote; see bioaccessla.com/sample-budget-fih-trial-latin-america)..

What a limited budget changes

A startup’s first human study is usually funded by one round and judged by the next. The budget question is not only how much, but what each dollar buys toward the milestone your investors and the U.S. Food and Drug Administration (FDA) care about. That shifts CRO selection toward three things: a fee model sized for one small study, fewer surprises after signature, and a country plan that reduces both per-patient cost and months of burn.

Where the money goes in an early-phase study

We split every early-phase budget into three buckets, all priced from the schedule of events, the visit-by-visit list of what happens to each patient. Our budget guide walks through each line.

Pass-throughs are site payments and vendor invoices the CRO pays on your behalf. They should be billed at cost and auditable against the underlying invoices; a general and administrative (G&A) charge of roughly 10–20% over third-party costs covers administering them.

Procedure intensity drives per-patient site cost. Our de-identified benchmarks put an outpatient ophthalmology implant at about $13K per patient, an inpatient orthopedic implant at about $25K–$28K, and a cath-lab peripheral vascular procedure at about $23K–$38K. All of these are planning benchmarks, not quotes.

Six criteria for choosing a CRO on a limited budget

1. A fee model sized for one study. Ask whether pricing is fixed, milestone-based or time-and-materials, and how change orders work. A proposal built from a full protocol and schedule of events is more reliable than one built from a synopsis.
2. Transparent pass-throughs. Every pass-through line should be auditable to an invoice.
3. Country choice as a cost lever. Country changes both cost and time. Our benchmarks put the cost of reaching an approval package at about $188K in Mexico and about $305K in Colombia, where INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) adds a technical-dossier step. Our Panama page publishes per-patient costs of $12K–$22K.
4. Start-up speed. Every month of start-up is a month of burn. In our experience, Panama, Chile, El Salvador and Costa Rica have the region’s quickest review pathways: in our recent plans, ethics and regulatory approval of a complete submission took about 1 to 3 months, while in Colombia, Mexico, Brazil and Argentina the regulator’s review typically adds months. Full site activation, from protocol synopsis to first patient, took about 8 to 9 months in our recent plans. Our site activation timeline guide breaks the clock down by phase.
5. A data package that survives review. A cheaper study is only cheaper if FDA can use the data. Device data must meet 21 CFR 812.28 (Title 21 of the U.S. Code of Federal Regulations, section 812.28).
6. Downstream fit. The early study should hand off cleanly to your pivotal CRO and, for devices, to market access.

How the CRO options compare for a startup

The descriptions come from each company’s own website. The last column lists questions we would ask every one of them, including us.

A first human study of a device needs hospital sites, investigators who already perform the procedure, and a team that runs ethics, import and enrollment in the chosen country. Whichever model you choose, ask how that work is staffed and priced for a study of your size.

Cutting cost without cutting the data package

• Right-size statistics, translations and electronic data capture (EDC) hosting, typically a $40,000–$50,000 cluster.
• Negotiate site and hospital payments hard at the CTA stage; they pass through at cost.
• Freeze the schedule of events before quoting. Scope creep after the proposal is the most expensive line item.
• Take monitoring in-house only if you truly have the capability.
• Expect an advance payment. It funds site contracting, imports and start-up work that must be paid before enrollment, and it is standard in the industry.
• Do not cut monitoring, data management or regulatory compliance. The savings are small and the risk to your FDA story is not.

Regulatory choices that change the budget

• Design to the FDA rule from day one. Under 21 CFR 812.28, FDA can accept data from a well-designed, well-conducted study outside the United States that followed good clinical practice, with independent ethics committee review and informed consent, and that FDA can validate. Align the design with FDA, usually through a Pre-Sub, before enrollment. Acceptance is decided case by case.
• Use the right standard. Device studies run under ISO 14155, the International Organization for Standardization (ISO) good clinical practice standard for device investigations.
• Plan the step after the study. For devices, registration costs belong in the plan. Our published market-access pricing for Latin America is two-part: a one-time registration fee per country by device class (from $4,000 in Colombia to $22,250 for Brazil Class III/IV), then a lower annual holder fee from year 2 ($3,900 to $7,500); see the rate card.

Questions to ask before you sign

• Is this quote built from my full protocol and schedule of events, or from a synopsis?
• Which lines are pass-throughs, and what G&A applies to them?
• What is fixed, what is variable, and what triggers a change order?
• Which country do you recommend for my budget, and why?
• What is your start-up clock, by stage, in writing?
• What happens if the agreed timeline slips for reasons within your control?

Where bioaccess® fits

bioaccess® fits MedTech startups whose next milestone is a first human device dataset that can support a U.S. submission, on a budget that cannot absorb a program built for a much larger study. Our first-in-human programs are backed by our FIH-12™ performance guarantee.

If you need a multi-region Phase III, a global full-service CRO is the better fit. For line-item detail, see our costs and timelines page, our pre-quote checklist and our early feasibility CRO selection guide, or book a 30-minute call.

Frequently asked questions

What is the best CRO for a startup running an early-phase trial on a limited budget?

The best fit is a CRO whose pricing and staffing are sized for one small study, whose pass-through costs are auditable, and whose country plan lowers site costs and start-up time without weakening the data package.

How much does a first-in-human device study cost in Latin America?

bioaccess® publishes CRO professional services of about $350,000 for a standard study with 1 site, 10 subjects and a 24-month duration, plus about $50,000 in third-party costs and $5,000–$50,000 in hospital fees depending on procedure complexity. Your figure depends on patient count, visit schedule, procedure and country.

What is negotiable in a CRO proposal?

The CRO’s professional fees are where flexibility lives. Third-party vendor costs can be negotiated with the vendors but not repriced, site payments are negotiated at the clinical trial agreement stage, and an advance payment is standard in the industry.

Where can a startup cut trial costs without hurting data quality?

Right-size statistics, translations and electronic data capture (EDC) hosting, which together are typically a $40,000–$50,000 cluster, negotiate site payments at the clinical trial agreement stage, and freeze the schedule of events before quoting. Do not cut monitoring, data management or regulatory compliance.

Is a large global CRO ever the better choice on a budget?

Yes, when the job matches its model. A multi-region program that needs one vendor across phases and regions fits a global full-service CRO such as Medpace or Parexel. For a single small device study, compare every option on fee model, pass-through transparency, country plan and data quality.

Can data from a lower-cost Latin American study support an FDA submission?

It can, if the study meets FDA’s foreign-data rule for devices, 21 CFR 812.28. That means a well-designed, well-conducted study under good clinical practice, with independent ethics committee review, informed consent and data FDA can validate. Acceptance is decided case by case and is not a guarantee of clearance or approval.

Fast regulatory approval in Latin America comes from two choices made together: the right country pathway and a contract research organization (CRO) that already works that pathway every week. For first-in-human (FIH) and early feasibility medical device studies, bioaccess® concentrates on the region’s fastest-start jurisdictions, where in our experience Panama, Chile, El Salvador and Costa Rica have the quickest review pathways: in our recent plans, ethics and regulatory approval of a complete submission took about 1 to 3 months. Global full-service CROs such as Parexel and Medpace also list Latin American offices on their websites and are built for larger multi-country programs.

This article explains what “approval” really covers, compares the main countries using the timelines we already publish, and gives criteria for judging any CRO on regulatory speed.

What “fast approval” actually includes

Sponsors often ask about the regulator alone. The clock you actually wait on has four parts:

• Ethics committee review of the protocol, informed consent form (ICF) and investigator. Depending on the country, the committee is called a CEI (Comité de Ética en Investigación), an Ethical-Scientific Committee or an institutional review board (IRB).
• National regulatory authorization, where the country requires it for an investigational device.
• Investigational device import, through a formal, traceable import permit.
• Site contract and activation, including the clinical trial agreement (CTA).

In the fastest markets, ethics and regulator submissions run in parallel rather than one after the other. Across Latin America, ethics committees routinely review FIH protocols on a timeline set by each committee’s meeting schedule, compared with 6 to 12 months in the U.S.

Activation is not the same as first patient in. Qualifying and contracting the investigators who will enroll takes 1 to 3 months and should run in parallel with regulatory start-up; after approvals, the first patient typically follows in about a month.

Country by country: where approval is fastest

The table uses only timelines already published on bioaccessla.com. Treat them as indicative planning figures, not guarantees; committee calendars and agency queues change.

Small markets can activate quickly and still enroll slowly. Choose the country on real site-level patient flow for your indication, not on the clock alone, and test two or three countries in feasibility before committing. Our startup-clock guide and our fast-track corridor deep dive go country by country.

A note on Colombia

Colombia is where bioaccess® built its earliest FIH capability, and we have completed 30+ FIH device studies there. The additional INVIMA technical-dossier step is why our benchmarks put the cost of reaching an approval package in Colombia at roughly 1.6 times Mexico’s. We still run clinical trials in Colombia and recommend it when the device, sites and file fit.

How to judge a CRO on regulatory speed

1. Pathway ownership. Has the team filed your exact pathway, for your device class, recently? Ask for de-identified submission and approval dates.
2. In-country entity and importer of record. A CRO with a local legal entity can own submissions and imports directly. In Colombia, for example, our Colombian entity owns INVIMA submissions, ethics-committee work and investigational-device import.
3. Parallel submissions. Ask which submissions the CRO runs in parallel in your country, and which must be sequential.
4. Dossier quality and translation. Most start-up delay is rework, not review. Submissions must be in Spanish or Portuguese; bioaccess® works with its sister company Amavita Sciences™, the group’s in-house Latin American regulatory-translation infrastructure.
5. Query turnaround. A slow answer to a committee question is the biggest avoidable delay. Ask how the CRO tracks and answers queries, and how fast.
6. A written clock. Ask for the timeline by country and by stage, in writing, before you sign.
7. U.S. Food and Drug Administration (FDA) design intent. Speed is worth little if the data cannot support your U.S. submission.

How the CRO options compare in Latin America

Presence is not the same as pathway speed. Whichever CRO you consider, ask who would own local ethics, regulatory and import work day to day, and ask for its own recent clocks in your target country for your device class.

Speed and FDA acceptance are compatible

Under 21 CFR 812.28 (Title 21 of the U.S. Code of Federal Regulations, section 812.28), FDA can accept data from a well-designed, well-conducted study outside the United States when it followed good clinical practice (GCP), including independent ethics committee review and informed consent, and FDA can validate the data. How quickly a study was approved is not one of those conditions. Device studies should run under ISO 14155, the International Organization for Standardization (ISO) GCP standard for device investigations, and design should be aligned with FDA, typically through a Pre-Submission, before enrollment. Eligibility for FDA review is not a guarantee of clearance or approval. Our FDA acceptance guide covers the rule in detail.

Questions to ask a CRO about approval timelines

• What were your last three approval clocks in this country for a device like mine?
• Which steps run in parallel, and which are sequential?
• Who is importer of record, and when is the import permit filed?
• Who translates the dossier, and who answers committee queries?
• What happens contractually if the agreed timeline slips?

Where bioaccess® fits

bioaccess® fits sponsors who want FIH or early feasibility data from the region’s fastest-start jurisdictions, with one team handling ethics, regulatory, import and site activation, and a U.S. regulatory anchor. Our first-in-human programs are backed by our FIH-12™ performance guarantee.

Speed also has a budget side: every month of start-up is a month of burn. Our costs and timelines page and our FIH budget guide show how country choice changes both. If your program is a multi-region Phase III, a global full-service CRO is the better structural fit. See our ethics committee timelines, Latin America FIH benchmarks and country hubs, or book a 30-minute call.

Frequently asked questions

Which Latin American country has the fastest clinical trial approval for a device first-in-human study?

In our experience, Panama, Chile, El Salvador and Costa Rica are the fastest: in our recent plans, ethics and regulatory approval of a complete submission took about 1 to 3 months, and site activation from protocol synopsis to first patient about 8 to 9 months. The right choice still depends on whether the country’s sites can enroll your indication.

Which CROs are best for fast regulatory approval in Latin America?

Look for a CRO that has filed your exact country pathway recently, can act as importer of record, submits to ethics and regulator in parallel, and puts a country-by-country clock in writing. bioaccess® is a first-in-human CRO built around the region’s fastest-start jurisdictions; global full-service CROs such as Parexel and Medpace list Latin American offices and are built for larger multi-country programs.

How long does ethics committee approval take in Latin America?

Latin American ethics committees routinely review first-in-human protocols on a timeline set by each committee’s meeting schedule, compared with 6 to 12 months in the U.S. In Panama, bioaccess® publishes a 3–5 week ethics approval.

Does bioaccess® still run clinical trials in Colombia?

Yes. bioaccess® still runs clinical trials in Colombia and recommends it when the device, sites and file fit. INVIMA, ethics and import work sit with our Colombian legal entity.

Does faster approval make the data less useful for the FDA?

No. Under 21 CFR 812.28, what matters is that the study was well designed and well conducted under good clinical practice, with independent ethics committee review and informed consent, and that FDA can validate the data. How quickly the study was approved is not one of the conditions.

Do I need national regulator approval as well as ethics approval?

It depends on the country and device class. Colombia, for example, requires INVIMA authorization for an investigational device, while in some other countries the ethics committee is the primary gate. Confirm the requirement for each country during feasibility.