Category: First-in-Human

Sponsors comparing Latin American countries often hear a shortcut about Chile: device studies only need ethics approval and an import permit, and the regulator stays out of the way. That shortcut is out of date. Chile’s Instituto de Salud Pública (ISP) authorizes both drug trials and device trials. The real differences sit somewhere else: in which agency inside ISP handles the file, which rules were written with devices in mind, and how settled the device guidance is.

The short version

• Same legal gate. Since Ley 20.850 (2015), Código Sanitario Article 111 A requires an ISP “autorización especial para uso provisional con fines de investigación” for pharmaceutical products and medical devices (“elementos de uso médico”) used in research on humans.
• Ethics first. The ISP application comes after approval under Article 10 of Ley 20.120, which requires a favorable report from an accredited Comité Ético Científico (CEC).
• Different agencies. Drugs go through ISP’s Agencia Nacional de Medicamentos (ANAMED). Devices go through the Agencia Nacional de Dispositivos Médicos (ANDIM).
• Different rulebooks. Several older Chilean research instruments, including Norma Técnica 57, were written for medicines. The device route rests mainly on the Código Sanitario and device-specific ISP guidance, and some of that guidance is still being finalized.

Two agencies inside one institute

ISP is Chile’s national regulator for medicines and medical devices. Drug work, including ISP’s clinical studies pages for investigational medicines, sits under ANAMED. Device work sits in ANDIM. On its agency page, ISP describes ANDIM as responsible for the safety and performance of medical devices, including in vitro diagnostic devices (IVDs), through authorization, control, inspection and surveillance across the whole device life cycle.

A standalone device goes to ANDIM. A combination product may involve both.

What is the same for drug and device trials

The CEC review comes first

Ley 20.120 is Chile’s law on scientific research in human beings. Its regulation, Decreto Supremo (DS) 114 of 2010, as amended in 2013, requires every study to have “una revisión e informe favorable de un Comité Ético Científico acreditado.” For multicenter studies, one accredited committee does the scientific and ethical review, and each site adds a local feasibility evaluation. Under DS 114 Article 18, the CEC must issue its report within 45 days of submission, a deadline it can extend once by 20 days for stated reasons.

Article 111 A then makes the order explicit: the ISP application is filed “previa aprobación conforme a lo dispuesto en el artículo 10 de la ley N°20.120,” with the protocol, the informed consent form, the insurance policy and any other document the regulation requires. For devices and drugs alike, the CEC letter comes before the ISP file.

ISP issues a provisional-use authorization

Article 111 A says the authorization is required for any drug or medical device used in research that lacks a sanitary registration, or that has one but will be used differently from how it was registered. The authorization lasts up to one year and can be renewed. The product can only be used as the authorization allows, and ISP must keep a public registry of the research it authorizes.

Shared obligations during and after the study

• Safety reporting: adverse events go to ISP and the CEC, under pharmacovigilance rules for drugs and technovigilance rules for devices (Article 111 B).
• Post-trial access: the authorization holder must continue treatment at no cost while it remains useful, as described in the protocol (Article 111 C). Our note on post-trial access in Chile under Ley 20.850 covers how this works in practice.
• Site accreditation and inspection: research centers must be accredited by ISP, which can inspect protocols, consent, GCP compliance and safety reporting (Article 111 D).
• Liability and insurance: authorization holders are liable for harm caused by the research (Article 111 E) and must carry civil liability insurance under the applicable regulation (Article 111 F). For devices, Article 111 F says a supreme decree sets the device classes for which insurance is mandatory. Our note on Chile clinical trial insurance covers the ethics-committee side.
• Institutional sign-off: under DS 114 Article 10 bis, the director of each research site authorizes the study within 20 business days of the favorable CEC review and, where applicable, the ISP authorization.

Where drug and device trials genuinely differ

The older rulebook was written for medicines

Much of what sponsors read about Chilean trial rules comes from instruments that name drugs, not devices:

• Código Sanitario Article 99 lets ISP provisionally authorize the use of pharmaceutical products without registration for clinical trials, subject to a favorable CEC report.
• DS 114 Article 7 gives ISP the power to “autorizar el uso de medicamentos con o sin registro sanitario, con fines de investigación científica y ensayos clínicos.” The article speaks of medicines only.
• Norma Técnica 57, approved by Ministry of Health (MINSAL) Exempt Resolution 952 of 2001, is titled “Regulación de la ejecución de ensayos clínicos que utilizan productos farmacéuticos en seres humanos.”

For devices, the legal basis is Código Sanitario Article 111 A. It is backed by Article 111 letter g, which says ISP must authorize the use and disposal of the medical elements covered by Article 111, and by DS 825 of 1998, the regulation on the control of medical-use products and elements. A drug-trial checklist will not map cleanly onto a device file.

What ISP looks at

For drugs, ISP has said publicly that it assesses the investigational medicine “teniendo a la vista el protocolo del ensayo clínico, el manual del investigador y certificaciones” such as Good Clinical Practice (GCP) and Good Manufacturing Practice, and decides by reasoned resolution (ISP, 2020).

For devices, ISP ran a public consultation from 5 June to 5 July 2026 on a guide explaining how to organize an application for provisional-use authorization of a medical device in clinical research in humans. Check whether the final guide has been published before you assemble your file. Until it is, build the dossier around ISO 14155:2020, the international standard for good clinical practice in medical device investigations: the clinical investigation plan, the investigator’s brochure, and the risk analysis behind them. Then confirm the exact document list with ANDIM.

A possible exemption for low-risk devices

Article 111 A lets MINSAL exempt, by supreme decree, “los elementos de uso médico cuya utilización no conlleve un riesgo relevante para las personas.” Article 111 A offers no equivalent carve-out for drugs. We have not confirmed that an exemption decree is in force, so treat this as something to check for your device, not an assumption.

Commercial registration status plays a different role

Most medical devices in Chile still do not need an ISP sanitary registration to be sold. ISP’s own registration page lists a short set of products under mandatory registration: latex gloves, condoms, sterile hypodermic needles and syringes, portable automated external defibrillators, HIV in vitro diagnostic (IVD) tests, immunohematology reagents and IVD reagents for screening blood donations. Exempt Decree 25 of 2026 adds 39 more. Registration becomes mandatory for 13 of them 24 months after publication (19 March 2028) and for the other 26 after 36 months (19 March 2029). The decree governs manufacture, import, sale and distribution, and it does not mention clinical investigation. An investigational device therefore does not need a registro sanitario. It needs the Article 111 A authorization. Our Chile ISP clinical-trial path for medical devices explains how to keep the trial file and the Decree 25 registration file on separate timelines.

What this means for your timeline

Because the CEC review comes before the ISP application, a Chilean device study runs in sequence: ethics review, then ISP authorization and investigational import, then the site director’s authorization. The primary sources set some of the clocks: 45 days for the CEC report (extendable once by 20 days) and 20 business days for the site director. For the ISP step, our Chile ISP device trial page plans on about 30 business days after a complete package, to be confirmed at filing. For overall site activation, our phase-by-phase site activation timeline guide shows that, in our recent plans, ethics and regulatory approval of a complete submission in the fast-corridor countries, Chile included, took about 1 to 3 months, and activation from protocol synopsis to first patient about 8 to 9 months. Treat both as planning figures, not guarantees.

So the fair comparison with the US is not “no regulator review in Chile.” It is an ISP device authorization that follows an accredited CEC review, with legal deadlines on the ethics and site-director steps.

Chile, IMDRF and using the data elsewhere

ISP says Chile has been an affiliate member of the International Medical Device Regulators Forum (IMDRF) since November 2023. Affiliate status signals regulatory convergence. It does not mean ISP accepts another regulator’s decision in place of its own trial authorization.

If you plan to use Chilean data outside Chile, design the study for that from day one. Under 21 CFR 812.28, the US Food and Drug Administration (FDA) can accept a foreign clinical investigation that supports an investigational device exemption (IDE) or a marketing submission, if the study was well designed, well conducted and followed GCP, including independent ethics committee review and informed consent, and FDA is able to validate the data, by inspection or other means if needed. In Europe, the EU Medical Device Regulation (MDR) 2017/745 sets out clinical investigation requirements in Article 62 and Annex XV. Your notified body will judge how data generated outside the EU fits your clinical evaluation.

Checklist for device sponsors considering Chile

• Confirm the file goes to ANDIM, and flag early any drug or biologic component.
• Choose a lead accredited CEC and each site’s local review route before you finalize the protocol.
• Prepare the Article 111 A package: protocol, Spanish informed consent form, insurance policy, and ISO 14155-aligned device documents.
• Check whether ISP has published the final device provisional-use guide, and whether any low-risk exemption or insurance-class decree applies to your device.
• Plan investigational import alongside the ISP step, not after it.
• Keep any Decree 25 commercial registration work on a separate timeline.

Frequently asked questions

Does Chile’s ISP approve medical device clinical trials, or only the import?

ISP does more than clear the import. Código Sanitario Article 111 A, added by Ley 20.850 in 2015, says drugs and medical devices used in research on humans need a special provisional-use authorization from ISP. That applies when the device has no sanitary registration, or when it has one but will be used differently from how it was registered.

Does the ethics committee or ISP go first in Chile?

The ethics committee goes first. Under Article 111 A, the sponsor files with ISP only after the study has been approved under Article 10 of Ley 20.120, which requires a favorable report from an accredited Comité Ético Científico (CEC). The application must include the protocol, the informed consent form and the insurance policy.

Does Norma Técnica 57 apply to medical device trials?

Not on its face. Norma Técnica 57, approved by Ministry of Health Exempt Resolution 952 of 2001, regulates clinical trials that use pharmaceutical products in humans. The device rules come from Código Sanitario Articles 111 and 111 A, Decreto Supremo 825 of 1998 and ISP guidance. Confirm current requirements with ISP.

Does an investigational device need a registro sanitario before a trial in Chile?

No. Commercial sanitary registration and research use are separate. Article 111 A covers devices that do not have a registration, which is why the trial needs ISP’s provisional-use authorization instead. Exempt Decree 25 of 2026 widens commercial registration but says nothing about clinical investigations.

Can data from a Chile device study support an FDA or EU submission?

It can, if the study is designed for that. Under 21 CFR 812.28, FDA can accept a well-designed, well-conducted foreign study that followed good clinical practice, including independent ethics review and informed consent, if FDA can validate the data. For Europe, plan against EU MDR Article 62 and Annex XV. Acceptance is decided case by case.

This article is general information, not legal advice. Requirements change, and ISP’s device research guide was under public consultation in 2026. Verify current requirements with ISP and your CEC before filing.

Considering Chile for a device study? bioaccess® can map feasibility, CEC routes, ISP authorization and site access for your protocol. Contact bioaccess® at bioaccessla.com to start.

Names and roles cited from live ClinicalTrials.gov records NCT07461818, NCT06815939, NCT07538050, and NCT07232355 (overall-official, central-contact, and location-contact fields), checked 27 September 2026. Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current El Salvador and U.S. regulatory and ethics rules with qualified advisers. We do not reprint emails or phones and do not add affiliations beyond the registry strings cited here.

If you searched Karla Alfaro MD El Salvador, Dr Karla Alfaro clinical trial, Karla Alfaro Basic Health International, or “go direct to Karla Alfaro,” you followed investigator and contact strings ClinicalTrials.gov publishes. The work visible on those records is cervical cancer screening and pre-cancer treatment in El Salvador. A named principal investigator is not a first-in-human (FIH) medical-device contract research organization (CRO), and a personal reply is not the operator of the national file.

bioaccess®’s position is simple and it is not adversarial: the investigator is part of the site. The CRO still owns the Superintendencia de Regulación Sanitaria (SRS) and Comité Nacional de Ética de la Investigación en Salud (CNEIS) filings, investigational import, insurance, ISO 14155 monitoring, and the 21 CFR 812.28 package.

Registry roles, copied as listed (checked 27 September 2026)

Registry count: ALL 4 / DEVICE 2. All four records are listed as RECRUITING.

Record	Sponsor	Type / intervention	Status	Role(s) listed for Karla Alfaro
NCT07461818 (POC)	Basic Health International, Inc.	Interventional; IRIS™ Thermal Ablation Device (DEVICE); estimated 5,000	RECRUITING	Overall PRINCIPAL_INVESTIGATOR (affiliation Basic Health International, Inc.), shared with Rachel Masch, MD; central CONTACT
NCT06815939 (OPTICS)	DL Analytics	Interventional screening; interventions include the EVA System (DEVICE); estimated 10,000	RECRUITING	Overall PRINCIPAL_INVESTIGATOR (affiliation Basic Health International, Inc.), shared with David Levitz, PhD (DL Analytics); site PRINCIPAL_INVESTIGATOR and CONTACT at “Ministerio de Salud,” San Salvador
NCT07538050 (SCALE AIM 2)	The Cleveland Clinic	Interventional; same-day screen and treat (BEHAVIORAL); estimated 1,000	RECRUITING	Site PRINCIPAL_INVESTIGATOR and CONTACT (listed as “Karla Alfaro, MD, MPH”) at “Ministry of Health Clinics,” San Salvador
NCT07232355 (PROGRESS)	Atila Biosystems Inc.	Observational; estimated 5,000	RECRUITING (see note)	Site CONTACT at Basic Health International, San Salvador

Notes from the records themselves: OPTICS lists an estimated primary completion of 31 July 2026, which has passed, and an estimated study completion of 31 December 2026. PROGRESS lists estimated completion in June 2026, which has passed, and was last updated 19 November 2025, so its recruiting status is unconfirmed. SCALE AIM 2 started 16 April 2026. POC started 1 January 2026. None of the four records calls itself first-in-human, and none names a CRO.

Facility page for the site she is most often tied to on the registry: Basic Health International San Salvador. The Ministry of Health locations are listed only as generic strings (“Ministerio de Salud,” “Ministry of Health Clinics”), so we do not name a specific clinic.

The contact is the contact. The CRO is the operator.

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

• Discuss investigator interest and whether a protocol fits an existing service.
• Share local research rules and how the cases would physically run.
• Estimate local visit, staffing, and procedure effort for the cases they will run.

What a contact is not built to own for an investigational device:

• SRS authorization and the CNEIS packet, filed in parallel on the national digital platform.
• Investigational import and device accountability — see importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a premium here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF).
• The 21 CFR 812.28 package. Eligibility is not clearance, and a site agreement does not produce it.

Going direct is how you confirm a room and a person. It is not how you open an investigational file.

Regulator, ethics, timeline, and cost (published figures)

These lines are copied from the published bioaccess® post El Salvador first-in-human cost and timeline vs the United States, not re-averaged here:

• The live El Salvador hub already publishes a 30–60 day study-startup band via parallel review by the Superintendencia de Regulación Sanitaria (SRS) and the Comité Nacional de Ética de la Investigación en Salud (CNEIS) on one digital platform. That band is investigation authorization plus ethics — not commercial registro.
• SRS replaced the former Dirección Nacional de Medicamentos (DNM) in August 2024. Ethics stays centralized at CNEIS.
• The El Salvador hub already publishes roughly 60% cost savings versus equivalent U.S. programs, plus a dollarized (U.S. dollar) economy. That is orientation from the country page, not a formal study for your device.

Ask for a study-specific calendar before you put a single date on a board slide. A site email is not an SRS authorization. Trial authorization and commercial registro are separate files; see CNEIS/SRS trial authorization vs registro.

All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Foreign clinical data can be eligible for U.S. Food and Drug Administration (FDA) submission and review under 21 CFR 812.28. Eligibility is not clearance or approval. See OUS FIH and FDA IDE.

Not a critique of the investigator

Karla Alfaro, MD is a named principal investigator on public cervical-screening and pre-cancer treatment records in El Salvador. That is evidence of a person doing registered research, not a punchline. Roles are as listed. Hire the operator. Activate a site only if it fits.

Colombia note

Colombia remains a strong market-access geography and a historical first-in-human geography for bioaccess®. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. We pick the country the device needs.

Frequently asked questions

Can I email Karla Alfaro, MD directly about a device study?

You can try through whatever channel the public registry exposes. A named investigator can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your SRS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager.

What roles does ClinicalTrials.gov show for her?

Overall PRINCIPAL_INVESTIGATOR on NCT07461818 and NCT06815939; central CONTACT on NCT07461818; site PRINCIPAL_INVESTIGATOR and CONTACT on NCT06815939 and NCT07538050; site CONTACT on NCT07232355.

Did bioaccess® run any of these studies?

No public bioaccess® page says so, and the records do not name a CRO. We will not invent that claim.

Next step

Start as the operator: contact bioaccess® or First-in-Human CRO. Country system: clinical trials in El Salvador. Facility sibling: Basic Health International San Salvador.

Facts cited from live ClinicalTrials.gov records NCT07461818 and NCT07232355 (checked 27 September 2026), plus collaborator fields on NCT06815939 and NCT05431699, and the published bioaccess® post El Salvador first-in-human cost and timeline. General information, not legal or regulatory advice. Confirm current El Salvador and U.S. regulatory and ethics rules with qualified advisers. bioaccess® is not listed on these records and no bioaccess® page claims these studies.

If you searched Basic Health International El Salvador, IRIS thermal ablation clinical trial San Salvador, cervical pre-cancer trial El Salvador, or “go direct to Basic Health International,” you followed a facility string ClinicalTrials.gov actually published: Basic Health International, San Salvador, El Salvador. On the registry it is both a study sponsor and a study site. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the national file.

bioaccess®’s position is simple and it is not adversarial: a site is a site. The CRO still owns the Superintendencia de Regulación Sanitaria (SRS) and Comité Nacional de Ética de la Investigación en Salud (CNEIS) filings, investigational import, insurance, ISO 14155 monitoring, and the 21 CFR 812.28 package for a sponsor’s own device.

What the registry says (checked 27 September 2026)

Registry count for the facility string “Basic Health International” in El Salvador: ALL 2 / DEVICE 1. Both records are listed as RECRUITING.

NCT07461818 — POC (device, RECRUITING)

NCT07461818 — acronym POC, brief title “Point of Care – Triage and Treatment for Cervical Pre-cancer.” Lead sponsor: Basic Health International, Inc.; collaborators The Cleveland Clinic, Liger Medical Llc, and Medical College of Wisconsin. Status: RECRUITING. Actual start 1 January 2026; estimated enrollment 5,000; estimated primary completion January 2029; estimated study completion August 2029. First posted 10 March 2026; last update posted 28 August 2026.

• Intervention: IRIS™ Thermal Ablation Device (type DEVICE), used in a modified two-probe thermal ablation protocol.
• Conditions: cervical precancer, cervical intraepithelial neoplasia (CIN), and human papillomavirus (HPV) infection. Eligibility: women aged 30 to 49.
• Primary outcome listed: 1-year cure rate of CIN2+. The summary also describes a retrospective look at an automated visual evaluation (AVE) triage method against histopathology.
• Named people, copied as listed: overall principal investigators Karla Alfaro, MD and Rachel Masch, MD (both affiliated with Basic Health International, Inc.); central contact Karla Alfaro, MD; site contact Leticia Lopez, MD.
• Location row: Basic Health International — San Salvador — El Salvador — RECRUITING. It is the only location on the record.

NCT07232355 — PROGRESS (observational, RECRUITING, record looks stale)

NCT07232355 — acronym PROGRESS, brief title “Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling.” Lead sponsor: Atila Biosystems Inc.; collaborator Basic Health International, Inc. Study type observational; estimated enrollment 5,000; actual start 24 August 2023. Status: RECRUITING, but the estimated primary and study completion dates (June 2026) have passed and the last update was posted 19 November 2025, so treat the status as unconfirmed. Locations are listed in El Salvador, Honduras, and the United States. The San Salvador row is Basic Health International, with Karla Alfaro, MD as site contact.

Where Basic Health International appears without a site row

The registry also lists Basic Health International, Inc. as a collaborator on two Ministry of Health studies — NCT06815939 (OPTICS, sponsor DL Analytics, RECRUITING) and NCT05431699 (SCALE, sponsor The Cleveland Clinic, ACTIVE_NOT_RECRUITING) — whose San Salvador location is listed as “Ministerio de Salud,” not Basic Health International. We do not count those as site rows here.

None of these records calls itself first-in-human, and none names a CRO.

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

What Basic Health International can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol fits an existing service.
• Share local research rules and how the cases would physically run.
• Estimate local visit, staffing, and procedure effort for the cases they will run.

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

• SRS authorization and the CNEIS packet, filed in parallel on the national digital platform.
• Investigational import and device accountability — see importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a premium here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF).
• The 21 CFR 812.28 package. Eligibility is not clearance, and a site agreement does not produce it.

Going direct is how you confirm a room and a person. It is not how you open an investigational file.

Regulator, ethics, timeline, and cost (published figures)

These lines are copied from the published bioaccess® post El Salvador first-in-human cost and timeline vs the United States, not re-averaged here:

• The live El Salvador hub already publishes a 30–60 day study-startup band via parallel review by the Superintendencia de Regulación Sanitaria (SRS) and the Comité Nacional de Ética de la Investigación en Salud (CNEIS) on one digital platform. That band is investigation authorization plus ethics — not commercial registro.
• SRS replaced the former Dirección Nacional de Medicamentos (DNM) in August 2024. Ethics stays centralized at CNEIS.
• The El Salvador hub already publishes roughly 60% cost savings versus equivalent U.S. programs, plus a dollarized (U.S. dollar) economy. That is orientation from the country page, not a formal study for your device.

Ask for a study-specific calendar before you put a single date on a board slide. A site email is not an SRS authorization. Trial authorization and commercial registro are separate files; see CNEIS/SRS trial authorization vs registro.

All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Foreign clinical data can be eligible for U.S. Food and Drug Administration (FDA) submission and review under 21 CFR 812.28. Eligibility is not clearance or approval. See OUS FIH and FDA IDE.

Named investigator

The person who appears most often on these records has her own page: Karla Alfaro, MD. That page lists her registry roles exactly as ClinicalTrials.gov shows them.

Separate from other San Salvador sites

Basic Health International is not Hospital Nacional Zacamil and not the San Salvador eye clinics (Clínica Quesada, López Beltrán, El Dios de Israel). The Ministry of Health locations above are listed as generic strings and are not this facility.

Colombia note

Colombia remains a strong market-access geography and a historical first-in-human geography for bioaccess®. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. We pick the country the device needs.

Frequently asked questions

Can I contract Basic Health International directly for a device study?

You can try. A site can discuss interest and local visit costs. It cannot become your SRS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because a registry record listed it. Contract the CRO; let the CRO activate the site if it fits.

Did bioaccess® run POC or PROGRESS?

No public bioaccess® page says so, and the records do not name a CRO. We will not invent that claim.

Is NCT07461818 a first-in-human study?

The record does not say so. It is a recruiting treatment study of a thermal ablation device with an estimated 5,000 participants.

Next step

Start as the operator: contact bioaccess® or First-in-Human CRO. Country system: clinical trials in El Salvador. Registry hub: ClinicalTrials.gov FIH sites vs the CRO.

Facts cited from the live ClinicalTrials.gov record NCT06591117, checked 27 September 2026, and the published bioaccess® post El Salvador first-in-human cost and timeline. General information, not legal or regulatory advice. Confirm current El Salvador and U.S. regulatory and ethics rules with qualified advisers. We name only the facility and the site contact the record lists. bioaccess® is not listed on this record and no bioaccess® page claims this study.

If you searched Centro de Diabetes Ocular El Dios de Israel, Ocumedex Vizio El Salvador, Vizio microshunt clinical trial, or “go direct to El Dios de Israel,” you followed a facility string ClinicalTrials.gov actually published: Centro de Diabetes Ocular El Dios de Israel, S.A, El Salvador. It is a real ophthalmic site on a recruiting device study. It is not a first-in-human (FIH) contract research organization (CRO), and it is not the operator of the national file.

bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The CRO still owns the Superintendencia de Regulación Sanitaria (SRS) and Comité Nacional de Ética de la Investigación en Salud (CNEIS) filings, investigational import, insurance, ISO 14155 monitoring, and the 21 CFR 812.28 package.

What NCT06591117 says (checked 27 September 2026)

NCT06591117 — brief title “The Vizio Clinical Study.” Lead sponsor: Ocumedex. Status: RECRUITING. Actual start 21 March 2026; estimated enrollment 50; estimated primary completion January 2028; estimated study completion March 2029. First posted 19 September 2024; last update posted 10 July 2026.

• Intervention: Vizio Aqueous Microshunt (type DEVICE).
• Condition: refractory glaucoma. Brief summary: evaluate the safety and efficacy of the Vizio Aqueous Microshunt for the treatment of refractory glaucoma.
• Primary outcomes listed: efficiency of intraocular pressure (IOP) reduction measured by applanation tonometry, and safety through adverse event reporting.
• Design fields: interventional; primary purpose TREATMENT; phase not applicable; ages 22 to 85.
• Location row, copied as listed: Centro de Diabetes Ocular El Dios de Israel, S.A — city field “Colonia Escalón” — El Salvador — site status RECRUITING. It is the only location on the record.
• Named people: the site contact is listed as “Joaquin Flores, Doctor” with the role CONTACT. The record lists two sponsor central contacts and no overall official (no principal investigator is named).

Registry count for this facility string on 27 September 2026: ALL 1 / DEVICE 1 (one record, and it has a device intervention). The record does not call the study first-in-human, and neither do we. It does not name a CRO.

Why this page exists

The published El Salvador country page names Ocumedex Vizio™ among its country-level FIH examples. ClinicalTrials.gov now ties that program to one named facility. This page answers the facility-name search and keeps the facts to the registry. The bioaccess® ClinicalTrials.gov hub lists this facility with the same record.

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

What El Dios de Israel can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol fits an existing service.
• Share local research rules and how the cases would physically run.
• Estimate local visit, staffing, and procedure effort for the cases they will run.

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

• SRS authorization and the CNEIS packet, filed in parallel on the national digital platform.
• Investigational import and device accountability — see importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a premium here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF).
• The 21 CFR 812.28 package. Eligibility is not clearance, and a site agreement does not produce it.

Going direct is how you confirm a room and a person. It is not how you open an investigational file.

Site versus CRO

Workstream	What the clinic (site) typically owns	What the CRO still owns
Glaucoma surgery capability	Operating room, surgeons, local staff, source documents	Protocol fit, training, device accountability
Ethics	Local coordination	CNEIS packet, informed consent, investigator’s brochure alignment
National authority	Not the permit holder by appearing on an NCT row	SRS investigation authorization
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

Regulator, ethics, timeline, and cost (published figures)

These lines are copied from the published bioaccess® post El Salvador first-in-human cost and timeline vs the United States, not re-averaged here:

• The live El Salvador hub already publishes a 30–60 day study-startup band via parallel review by the Superintendencia de Regulación Sanitaria (SRS) and the Comité Nacional de Ética de la Investigación en Salud (CNEIS) on one digital platform. That band is investigation authorization plus ethics — not commercial registro.
• SRS replaced the former Dirección Nacional de Medicamentos (DNM) in August 2024. Ethics stays centralized at CNEIS.
• The El Salvador hub already publishes roughly 60% cost savings versus equivalent U.S. programs, plus a dollarized (U.S. dollar) economy. That is orientation from the country page, not a formal study for your device.

Ask for a study-specific calendar before you put a single date on a board slide. A site email is not an SRS authorization. Trial authorization and commercial registro are separate files; see CNEIS/SRS trial authorization vs registro.

All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Foreign clinical data can be eligible for U.S. Food and Drug Administration (FDA) submission and review under 21 CFR 812.28. Eligibility is not clearance or approval. See OUS FIH and FDA IDE.

The San Salvador eye clinics are separate

Three named El Salvador eye facilities carry active device records on ClinicalTrials.gov. Keep them apart:

• Clínica Quesada — Horizon Surgical Systems’ Polaris early-feasibility study (NCT06990074, RECRUITING) plus two Zeiss intraocular lens records.
• Centro Panamericano de Ojos / Clínica López Beltrán — Alcon accommodating intraocular lens feasibility study (NCT07147192, ACTIVE_NOT_RECRUITING).
• Centro de Diabetes Ocular El Dios de Israel — this page, Ocumedex Vizio (NCT06591117, RECRUITING).

Same country, different buildings, different sponsors. Registry-wide context sits on the ClinicalTrials.gov FIH sites vs the CRO hub.

Colombia note

Colombia remains a strong market-access geography and a historical first-in-human geography for bioaccess®. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. We pick the country the device needs.

Frequently asked questions

Can I contract Centro de Diabetes Ocular El Dios de Israel directly?

You can try. A clinic can discuss interest and local surgical costs. It cannot become your SRS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Ocumedex listed it. Contract the CRO; let the CRO activate the site if it fits your protocol.

Did bioaccess® run the Vizio study?

No public bioaccess® page says so, and the record does not name a CRO. We will not invent that claim.

Who is the investigator?

The record names no principal investigator. It lists “Joaquin Flores, Doctor” as the site contact (role CONTACT). We do not add a title, specialty, email, or phone the record does not show.

Is this a first-in-human study?

The record does not say so. Its primary purpose field is TREATMENT, with estimated enrollment 50. It is a recruiting glaucoma device study at a named El Salvador site.

Next step

Start as the operator: contact bioaccess® or First-in-Human CRO. Country system: clinical trials in El Salvador. Sister sites: Clínica Quesada, López Beltrán.

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 Hospital San Vicente Fundación Medellín as a bioaccess® client.

If you searched Hospital San Vicente Fundacion Medellin first-in-human, Hospital Universitario San Vicente Fundacion clinical trial, San Vicente Fundacion Medellin device study, or “go direct Hospital San Vicente Fundación Medellín,” you followed a campus string ClinicalTrials.gov still publishes. Hospital San Vicente Fundación in Medellín, Colombia (also registered as Hospital Universitario San Vicente Fundación), 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 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, 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 hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Medellín Hospital San Vicente Fundación campus. It is DISTINCT from the Universidad de Antioquia Medellín page, from the San Vicente Fundación site listed in Rionegro (a different city, not counted here), from Centro Médico Privado San Vicente Diabetes in Córdoba, Argentina, and from Hospital São Vicente de Paulo in Passo Fundo, Brazil. Sharing Medellín or the name San Vicente 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 Medellín, 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.

• Hospital San Vicente Fundación (Medellín, Colombia) — registry strings counted: “Hospital San Vicente Fundación”; “Hospital Universitario San Vicente Fundacion”. ALL studies n=13; interventional n=11; DEVICE n=2. Example NCT IDs: NCT01864590, NCT05510193, NCT03345511.

Aliases are counted once per NCT ID for Medellín locations; 2 of the 13 are observational. Example IDs list the 2 DEVICE registrations first, then 1 non-device registration.

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 Hospital San Vicente Fundación in Medellín finds ALL n=13 (DEVICE n=2) without finding INVIMA. 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:

• 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 Hospital San Vicente Fundación is not a Universidad de Antioquia file and is not an INVIMA 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 Medellín 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 hospital

Hospital San Vicente Fundación is a serious named Medellín campus on the public registry. ALL n=13 and DEVICE n=2 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. 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 Hospital San Vicente Fundación Medellín 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, 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 Universidad de Antioquia Medellín?

No. Universidad de Antioquia Medellín is a distinct Medellín page already published. This page is Hospital San Vicente Fundación Medellín only.

Did bioaccess® run NCT01864590?

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. Medellín sibling (do not merge): Universidad de Antioquia Medellín.

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 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®