Category: Navigating Regulatory Landscapes in Latin America

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

If you searched Unicamp Campinas first-in-human, Hospital das Clinicas Unicamp clinical trial, Unicamp CRO, or “go direct Unicamp Campinas,” you followed a campus string ClinicalTrials.gov still publishes. Unicamp in Campinas, Brazil, is a real named university-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named Campinas Unicamp campus (alias includes Hospital das Clinicas da Unicamp). It is not university-of-campinas-fih if already live under a different fold, not Hospital Celso Pierro Campinas (already live), not Loema Instituto Pesquisa Campinas, and not Centro Pesquisa São Lucas Campinas. Sharing Campinas is not a license to collapse them. Unicamp is not Celso Pierro. Unicamp is not Loema.

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

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

Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Unicamp (Campinas, Brazil) — canonical NCT string: ALL interventional n=147; DEVICE n=2. Example NCT IDs: NCT04171063, NCT05017636.

Cite canonical ALL n=147 and DEVICE n=2. Do not clone Celso Pierro, Loema, or São Lucas Campinas onto this slug.

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

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

That is the leak: a founder searching Unicamp Campinas first-in-human finds ALL n=147 (DEVICE n=2) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

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

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

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

Do not smear the hospital

Unicamp is a serious named Campinas campus on the public registry. ALL n=147 and DEVICE n=2 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

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

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

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

Colombia is still on the map

Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Unicamp Campinas directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital Celso Pierro or Loema Campinas?

No. Hospital Celso Pierro Campinas and Loema Instituto Pesquisa Campinas are already live on their own slugs. This page is Unicamp only.

Did bioaccess® run NCT04171063?

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. Campinas sibling (do not merge): Hospital Celso Pierro Campinas.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital de Base Sao Jose do Rio Preto first-in-human, Hospital de Base SJRP clinical trial, Hospital de Base Rio Preto CRO, or “go direct Hospital de Base São José do Rio Preto,” you followed a campus string ClinicalTrials.gov still publishes. Hospital de Base in São José do Rio Preto, Brazil, is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named São José do Rio Preto Hospital de Base campus. It is DISTINCT from hospital-de-base-distrito-federal-brasilia-fih (Brasília / Distrito Federal — different city, different campus). It is not FAMERP São José do Rio Preto (already live). Sharing a Hospital de Base name is not a license to collapse Brasília and São José do Rio Preto. SJRP Hospital de Base is not Brasília Hospital de Base.

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

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

Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Hospital de Base (São José do Rio Preto, Brazil) — canonical NCT string: ALL interventional n=210; DEVICE n=1. Example NCT IDs: NCT04701684.

Cite canonical ALL n=210 and DEVICE n=1. Do not clone Hospital de Base Distrito Federal Brasília onto this slug.

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

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

That is the leak: a founder searching Hospital de Base São José do Rio Preto first-in-human finds ALL n=210 (DEVICE n=1) 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 RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Hospital de Base São José do Rio Preto is not a Brasília Distrito Federal Hospital de Base file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANVISA actually works (the short version)

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

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

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

Do not smear the hospital

Hospital de Base São José do Rio Preto is a serious named Brazilian campus on the public registry. ALL n=210 and DEVICE n=1 are registry volume, not a punchline. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

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

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

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

Colombia is still on the map

Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital de Base São José do Rio Preto directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital de Base Distrito Federal Brasília?

No. hospital-de-base-distrito-federal-brasilia-fih is already live for the Brasília campus. This page is Hospital de Base São José do Rio Preto only — different city.

Did bioaccess® run NCT04701684?

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. Distinct Brasília sibling (do not merge): Hospital de Base Distrito Federal Brasília.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from the PR Newswire release “Nanochon Performs First Case in the Chondrograft™ First in Human Clinical Study” (2 September 2026, 16:58 ET), the live ClinicalTrials.gov record NCT07542184 (last update posted 21 August 2026; first posted 21 April 2026), and published bioaccess® Panama pages, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the investigators, facility, and trial those sources support, and we do not reprint site contact emails or phone numbers. Nanochon is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT and did not run this study.

If you searched Dr. Juan Osorio Panamá, Juan Osorio principal investigator Chondrograft, Emilio Tufiño knee cartilage trial, Nanochon first case Panamá, or “go direct to the surgeon,” you followed an investigator string that public press and ClinicalTrials.gov both publish. Dr. Juan Osorio is a real named principal investigator. He is not the operator of the MINSA file.

bioaccess®’s position is simple and it is not adversarial: the investigator is the investigator and the hospital is the site. The First-in-Human CRO still owns MINSA / CNBI, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if Panamá is not the only fit. Sponsors who skip the CRO and email the surgeon still have to rebuild that stack. A principal-investigator line does not become a CRO.

This is a person-string intercept, and it exists only because the building already has its own page. The facility intercept stays at The Panama Clinic (Spanish: versión en español), and the distinct legal-entity string stays at CEVAXIN / The Panama Clinic. This page does not clone clinical trials in Panama. That page stays the country operating system.

Why the surgeon’s name wins the search — and why that is not a CRO

On 2 September 2026, Nanochon announced the successful treatment of the first patient in its First-in-Human study of Chondrograft™, a 3D-printed implant for articular cartilage defects of the knee. Per that release: Dr. Juan Osorio and Dr. Emilio Tufiño, both specialists in regenerative sports medicine, performed the first procedure at The Panama Clinic, Panamá. Dr. Osorio is quoted in the release identifying himself as the Principal Investigator for the study. Dr. Tufiño is quoted describing the procedure as “bone-sparing, minimally invasive, and streamlined.” The release also states that Nanochon plans a Level 1 multi-center, randomized, controlled pivotal trial after the FIH study, and that Chondrograft™ has FDA Breakthrough Device Designation. No CRO is named anywhere in that release.

The registry says the same thing in registry language. NCT07542184 — brief title: Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) – Panama. Official title: A First in Human (FIH) Early Feasibility Study (EFS) to Evaluate the Safety and Performance of the Nanochon Chondrograft™ Implant for Re-surfacing of Cartilage Lesions. Organization study ID: 101-2024 – PAN. Lead sponsor: Nanochon, Inc., class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed.

Design on the 3 September 2026 snapshot: interventional; single-group; no masking; primary purpose treatment; phase N/A; estimated enrollment 5. Actual start 30 July 2026; estimated primary completion and completion September 2027. Study first posted 21 April 2026; last update posted 21 August 2026 — that is, before the 2 September first-case announcement. Status RECRUITING. Condition: knee cartilage lesions, with registry keywords for medial and lateral femoral condyle and trochlear articular cartilage lesions. Intervention: a device — mini-arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft. Eligibility: male or female aged 22–60, MRI knee evaluation within six months, able to read and speak English and/or Spanish, and voluntary signature of the REB-approved informed consent.

The single Panama location row is The Panama Clinic, Panama City, Provincia de Panamá, RECRUITING, with Juan Osorio, MD listed as PRINCIPAL_INVESTIGATOR. That is the registry’s own field, not our inference. A sister Canadian record, NCT07249489 (same official title, org study ID 101-2024-CAN, estimated n=10, NOT_YET_RECRUITING, last update posted 2 September 2026), lists University of British Columbia in Vancouver and an Orthopaedic Clinic in Toronto. Canada is outside the Latin American geography this page covers; we note it so nobody merges the two records.

Read the two sources together. An estimated five patients, a 3D-printed implant, a Breakthrough-designated device, a planned pivotal RCT to follow — and the only human names a sponsor can find are two surgeons and a company CEO. That is the site-direct leak in its purest form: the search resolves to a person, and the person is not the operator of the file.

The investigator is the investigator. The CRO is the operator.

A regenerative sports-medicine surgeon in Panama City can carry the procedure, the surgical judgement, the follow-up exams, and the source documents. That is necessary, and on this program it is clearly working — the first case was enrolled and treated quickly enough that the sponsor made a point of it. It is still not the same job as owning a first-in-human file.

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

• Discuss investigator interest and surgical feasibility for a cartilage protocol — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote procedure, theatre, and local staffing costs for the cases they will physically perform.

What an investigator is not built to own for an investigational device:

• MINSA and the CNBI. The national file and the national bioethics pathway are not a hallway conversation with a surgeon.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit, end to end. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The published bioaccess® Panama planning band is $5,000–$15,000 depending on device risk and enrollment. That is a published planning band, not a quote for this study.
• ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF — across Panamá and any second country.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. A five-patient EFS that is meant to feed a Level 1 pivotal trial is exactly when one surgeon’s calendar stops being the plan.

Going direct to Dr. Osorio is how you confirm a surgeon. It is not how you open an investigational file.

Investigator versus CRO

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

• Device: Chondrograft™, a 3D-printed implant for focal articular cartilage defects of the knee, with FDA Breakthrough Device Designation per the company release.
• Sponsor: Nanochon, Inc. (industry). No collaborator on the NCT. No CRO named in the release or on the record.
• Site: The Panama Clinic, Panama City — the only Panama location row, RECRUITING. Already intercepted on its own page.
• Named investigators (as published): Juan Osorio, MD — principal investigator on the NCT row and self-identified as PI in the 2 September release; Emilio Tufiño, MD — named in the release as performing the first procedure. We do not merge them into a single identity and we do not add a third name.
• Milestone: first patient treated, announced 2 September 2026. Actual study start on the registry is 30 July 2026.
• Not claimed here: that bioaccess® ran this study or is on this NCT; that Nanochon is a bioaccess® client; that we have Chondrograft outcomes; that Breakthrough Device Designation is clearance or approval; that the Panama and Canada records are one study.

What the CRO still does after you have a surgeon’s name

• Regulatory-fit, not tourism. Panamá is a lead first-in-human jurisdiction on the published platform. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the MINSA / CNBI packet.
• Importer of record and implant accountability.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for the FDA conversation that a Breakthrough-designated implant will eventually need.
• Optionality when a five-patient EFS has to become a multi-centre pivotal study.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background: LATAM FIH hospitals vs the CRO.

Frequently asked questions

Why is there a page for a person rather than only for the hospital?

Because sponsors search the string they see, and the 2 September release put two surgeons’ names in front of the building. The facility page already exists at The Panama Clinic, and the legal-entity page exists at CEVAXIN. This page answers the investigator query and links back rather than duplicating either one.

Can I contract Dr. Osorio directly?

You can try. A principal investigator can discuss surgical feasibility, institutional ethics calendars, and local case costs. He cannot become your MINSA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because a press release named him. Contract the CRO; let the CRO activate the site and the investigator.

Did bioaccess® run the Chondrograft first-in-human study?

No. No public bioaccess® page says so, bioaccess® is not on NCT07542184, and we will not invent that relationship. This page intercepts the search; it does not claim the study.

Does Breakthrough Device Designation mean the implant is approved?

No. The company release states the designation; a designation is a review-interaction pathway, not clearance or approval. A first-in-human EFS is still an investigational study, and foreign data still has to meet 21 CFR 812.28 conditions to be eligible for FDA submission and review.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Panamá investigator search is not an instruction to abandon INVIMA. See CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT06152341 (last update posted 31 August 2026; first posted 30 November 2023) and the published bioaccess® Dominican Republic country page, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current DIGEMAPS, CONABIOS, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. No principal investigator is named on this NCT location row; we will not invent one. Akura Medical is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Centro de Intervenciones Cardiovasculares clinical trial, CIC Santiago de los Caballeros, Akura Medical ATC System, pulmonary embolism thrombectomy Dominican Republic, or “go direct to the Santiago site,” you followed a facility string ClinicalTrials.gov still publishes on 31 August 2026. Centro de Intervenciones Cardiovasculares in Santiago de los Caballeros, Santiago Province, is a real named cardiovascular facility on that record. It is not the operator of the DIGEMAPS file.

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

This page is the intercept for the Santiago de los Caballeros query. It does not clone clinical trials in the Dominican Republic. That page stays the country operating system. Sister Dominican intercepts stay on their own buildings: Laser Center Santo Domingo, Instituto Espaillat Cabral, and Clínica Canela La Romana. Santiago de los Caballeros is a different city from Santo Domingo and from La Romana. Do not merge the slugs. The two São Paulo rows on the same NCT already have their own intercepts: Instituto Dante Pazzanese and InCor HCFMUSP.

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

NCT06152341 is an industry device listing. Brief title: Safety and Effectiveness of the ATC System in the Treatment of Acute PE. Official title: Safety and Effectiveness of the ATC System in the Treatment of Acute Pulmonary Embolism. Organization study ID: CP-60003. Lead sponsor: Akura Medical, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed. The record publishes no central contact and no overall official.

Design on the 3 September 2026 snapshot: interventional; prospective, single-arm, multicenter; no masking; primary purpose treatment; phase N/A; estimated enrollment 30. Actual start 15 May 2024; estimated primary completion April 2027; estimated completion May 2027. Study first posted 30 November 2023; last update posted 31 August 2026. Condition: acute pulmonary embolism.

Status on that snapshot is SUSPENDED. The registry’s own reason, quoted as published: enrollment is temporarily paused pending device resupply to sites; enrollment is expected to resume to reach the target sample size following a recently approved protocol amendment; and the pause is not related to subject safety or device performance. We report that as written and add nothing to it.

Intervention, in the registry’s words: a device — the ATC System, designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE. The oversight module records the study as an FDA-regulated device study of an unapproved device that is a U.S. export. An unapproved, exported thrombectomy system running at 30 patients across three Latin American buildings is a CRO file, not a hospital favour.

The three location rows currently published:

• Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil — already intercepted.
• Instituto do Coracao (InCor), São Paulo, Brazil — already intercepted.
• Centro de Intervenciones Cardiovasculares, Santiago de los Caballeros, Santiago Province, Dominican Republic — this page. No principal investigator, contact, or row-level status is published for it.

Read the record as it is. Two Brazilian cardiology institutes had public intercepts and the Dominican row did not, even though it is the only Caribbean building on an unapproved-device PE study. That is the site-direct leak: a sponsor searching Akura, ATC System, or Santiago de los Caballeros interventional cardiology lands on a named hospital with no operator in the public copy.

Santiago de los Caballeros is a site. The CRO is the operator.

A Dominican interventional-cardiology centre can provide cath-lab time, a PE response pathway, imaging, and operators who do pulmonary-artery work. That is necessary. It is not sufficient for an unapproved, U.S.-exported thrombectomy system a sponsor expects to defend to a U.S. board later.

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

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

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

• DIGEMAPS. The Ministry of Public Health, through the Dirección General de Medicamentos, Alimentos y Productos Sanitarios, is the national authority for health products including medical devices. A cath-lab conversation is not that submission.
• CONABIOS-overseen ethics. The Consejo Nacional de Bioética en Salud oversees Research Ethics Committees; institutional REC review is tied to the host institution once the site is chosen.
• Investigational import. A separate permit from the trial authorization and from a later commercial DIGEMAPS registration. The live importer-of-record guide already records DIGEMAPS as created by Decreto 82-15 (2015), with registration and import rules in Decreto 246-06. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a Santiago-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF — including across the two São Paulo rows on the same NCT.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. A suspended-for-resupply study is precisely when a single-hospital MSA stops stretching.

Going direct to Centro de Intervenciones Cardiovasculares is how you confirm a cath lab. It is not how you open an investigational file.

Site versus CRO

How DIGEMAPS and CONABIOS sit next to the hospital

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

• Institutional REC review averages ~30 days; CONABIOS-level review averages ~45 days, up to 120 depending on complexity.
• DIGEMAPS is the national regulatory authority for health products including medical devices; CONABIOS oversees Research Ethics Committees.
• Protocols follow the Declaration of Helsinki and the CIOMS international ethical guidelines. The submission package is in Spanish.
• The country hub publishes ~30% lower program cost than a comparable U.S. or EU program — an experience-based estimate from work since 2010, not a formal study.
• Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not clearance or approval.
• A commercial DIGEMAPS registration is a second, separate file from a clinical-trial authorization.

We will not invent a Santiago-only day count. Ask for a protocol-specific calendar. A hospital email is not a DIGEMAPS authorization.

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

• Device: the ATC System for mechanical removal of emboli in acute pulmonary embolism, as described on NCT06152341.
• Sponsor: Akura Medical (industry). No collaborator. No CRO named.
• Sites: Instituto Dante Pazzanese and Instituto do Coracao, São Paulo (existing intercepts); Centro de Intervenciones Cardiovasculares, Santiago de los Caballeros (this page).
• Design: prospective single-arm multicenter, phase N/A, estimated n=30, actual start 15 May 2024.
• Status: SUSPENDED — enrollment paused pending device resupply, expected to resume after an approved protocol amendment; the registry states the pause is not related to subject safety or device performance.
• Regulatory flags on the record: FDA-regulated device; unapproved device; U.S. export.
• Not claimed here: that the NCT named bioaccess®; that Akura Medical is a bioaccess® client; that we have ATC outcomes; that a named investigator exists on this row when the registry prints none; that Santiago de los Caballeros is the same building as Santo Domingo or La Romana.

What the CRO still does after you have a hospital name

• Regulatory-fit, not tourism. The Dominican Republic is a lead first-in-human jurisdiction on the published platform. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the DIGEMAPS / CONABIOS packet — in Spanish.
• Importer of record and device accountability, including resupply across activated rows.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality when one Caribbean cath lab is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background: ClinicalTrials.gov FIH sites vs the CRO.

Frequently asked questions

Can I contract Centro de Intervenciones Cardiovasculares directly?

You can try. The facility can discuss investigator interest, local procedure costs, and REC calendars. It cannot become your DIGEMAPS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Akura listed Santiago on a registry row. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the Akura ATC study?

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

The study is SUSPENDED. Is that a safety problem?

The registry says no. Its stated reason is a temporary enrollment pause pending device resupply to sites, with enrollment expected to resume after an approved protocol amendment, and it explicitly states the pause is not related to subject safety or device performance. We quote that; we do not reinterpret it. Resupply across three countries is, however, exactly the import-and-accountability workstream a site does not own.

Who is the principal investigator in Santiago de los Caballeros?

The registry does not name one on this location row, and neither will we.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Dominican search is not an instruction to abandon INVIMA. See CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT05317728 (last update posted 1 September 2026; first posted 8 April 2022) and the published bioaccess® Mexico country page, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics-committee, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. No principal investigator is named on this NCT location row; we will not invent one. Alcon is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Centro de Retina Médica y Quirúrgica clinical trial, Zapopan Jalisco IOL study, Alcon fluid accommodating IOL Mexico, BAL-FAIOL site, or “go direct to the Zapopan site,” you followed a facility string ClinicalTrials.gov still publishes on 1 September 2026. Centro de Retina Medica y Quirurgica SC is a real named ophthalmology facility on that record. It is not the operator of the COFEPRIS file.

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

This page is the intercept for the Zapopan query. It does not clone clinical trials in Mexico. That page stays the country operating system. The two Mexico City rows on this same NCT get their own slugs: Asociación Para Evitar la Ceguera en México and Salauno Salud. This slug is the Zapopan retina campus string (ZIP 45116, Jalisco) only. It is not any other Jalisco research centre already on this site. Do not merge them.

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

NCT05317728 is an industry device feasibility listing. Brief title: Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design. Official title: Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control. Organization study ID: ILR286-E002. Lead sponsor: Alcon Research, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed. The only overall official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. There is no central contact and no principal investigator is named on any location row — we will not invent one.

Design on the 3 September 2026 snapshot: interventional; primary purpose DEVICE_FEASIBILITY; phase N/A; Cohort 1 randomized parallel-group with participant and outcomes-assessor masking, Cohort 2 single-group unmasked; actual enrollment 175; status ACTIVE_NOT_RECRUITING. Actual start 31 March 2023; estimated primary completion and completion November 2026. Study first posted 8 April 2022; last update posted 1 September 2026. Condition: cataract.

Interventions, in the registry’s words: the BAL-FAIOL IOL, an investigational implantable medical device intended for long-term use over the lifetime of the cataract subject; a commercially available monofocal IOL control (other name AcrySof IQ monofocal IOL, SN60WF); and cataract surgery by phacoemulsification with a clear corneal incision. The oversight module records the study as an FDA-regulated device study of an unapproved device that is a U.S. export. That combination — unapproved investigational IOL, exported from the United States, run in Latin America under a feasibility purpose — is exactly the file a CRO carries.

The six location rows currently published:

• Clinica 20/20, San José, Costa Rica — already intercepted at clinica-20-20-san-jose-fih.
• Laser Center SA, Santo Domingo, Dominican Republic — already intercepted at laser-center-santo-domingo-fih.
• Centro de Retina Medica y Quirurgica SC, Zapopan, Jalisco, Mexico.
• Asociación Para Evitar la Ceguera en México, Mexico City.
• Salauno Salud SAPI de CV, Mexico City.
• Panama Eye Center, Panama City — already intercepted at panama-eye-centre-orillac-calvo-miniject.

Read the record as it is. Primary purpose is DEVICE_FEASIBILITY. The device is unapproved. Three of the six buildings are in Mexico, and until this batch none of the three had a dedicated public intercept. That is the site-direct leak: a sponsor searching a fluid-accommodating IOL, Alcon feasibility, or a Mexican ophthalmology campus lands on a named facility with no operator between them and the file.

Zapopan is a site. The CRO is the operator.

Centro de Retina Medica y Quirurgica SC can provide cataract surgical volume, biometry and refractive outcome measurement, and surgeons who implant IOLs every week. That is necessary. It is not sufficient for an unapproved, U.S.-exported investigational lens a sponsor expects to defend later.

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

• Discuss surgeon interest and surgical feasibility for an investigational IOL — when that service is available and appropriate for your lens, which is not automatic.
• Share institutional ethics-committee calendars and clinic research rules.
• Quote surgery, visit, and local staffing costs for the cases they will physically run.

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

• COFEPRIS. Clinical investigations sit under the Ley General de Salud and its implementing regulations. The submission is in Spanish: protocol, investigator brochure, informed consent, ethics approval, proof of insurance. A conversation with a Monterrey dermatologist is not that dossier.
• Institutional ethics. Ethics-committee review under NOM-012-SSA3-2012 sits in front of the COFEPRIS file, and the committee is tied to the host institution once the site is chosen.
• Investigational import. Bringing an unapproved device into Mexico is a separate workstream from the trial authorization and from a later commercial registro sanitario. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a site-only premium here.
• ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. If one Mexican room is not enough, a single-clinic MSA will not stretch to Colombia, Panama, or Costa Rica.

Going direct to Centro de Retina Medica y Quirurgica SC is how you confirm an operating list. It is not how you open an investigational file.

Site versus CRO

How COFEPRIS and ethics sit next to the clinic

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

• Ethics at 4–6 weeks under NOM-012-SSA3-2012; COFEPRIS review at 4–8 weeks after ethics clearance; 2.8-month median start-up (attributed on that hub to NIH ClinRegs).
• Published per-patient range $18,000–$30,000; 10+ pre-qualified sites across Mexico City, Guadalajara, and Monterrey.
• The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada — a commercial market-access clock, not this trial clock.
• All COFEPRIS submissions are in Spanish, including protocol, investigator brochure, and informed consent.
• Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not a guarantee of clearance or approval.
• bioaccess®’s published cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study.

We will not invent a facility-only day count. Ask for a protocol-specific calendar. A clinic email is not a COFEPRIS authorization.

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

• Device: BAL-FAIOL fluid-accommodating intraocular lens, investigational and implantable, versus an AcrySof IQ SN60WF monofocal control, as described on NCT05317728.
• Sponsor: Alcon Research (industry). No collaborator. No CRO named.
• Site: Centro de Retina Medica y Quirurgica SC — one of six published location rows.
• Design: DEVICE_FEASIBILITY, phase N/A, actual n=175, ACTIVE_NOT_RECRUITING, actual start 31 March 2023, estimated completion November 2026.
• Regulatory flags on the record: FDA-regulated device; unapproved device; U.S. export.
• Not claimed here: that the NCT named bioaccess®; that Alcon is a bioaccess® client; that we have BAL-FAIOL outcomes; that a named investigator exists on this row when the registry prints none; that this facility is the same building as any sibling intercept.

What the CRO still does after you have a clinic name

• Regulatory-fit, not tourism. Mexico is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet — in Spanish.
• Importer of record and device accountability across every activated row.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality across Costa Rica, the Dominican Republic, Panama, Colombia, and the rest of the platform when one campus is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background on why registry rows keep outranking operators: ClinicalTrials.gov FIH sites vs the CRO and LATAM FIH hospitals vs the CRO.

Frequently asked questions

Can I contract Centro de Retina Medica y Quirurgica SC directly?

You can try. The facility can discuss surgeon interest, local case costs, and ethics-committee calendars. It cannot become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Alcon listed it on a registry row. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the Alcon fluid-accommodating IOL study?

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

Who is the principal investigator at this site?

The registry does not name one on this location row, and neither will we. The only official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. A page that invents a surgeon name to look authoritative is a page a sponsor should not trust.

The study is ACTIVE_NOT_RECRUITING. Why does this page exist?

Because the row is still published and still ranks. Sponsors planning the next feasibility IOL study search the campus strings on the last one. Enrollment status changes; the search behaviour does not.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Mexican ophthalmology search is not an instruction to abandon INVIMA. See CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT05317728 (last update posted 1 September 2026; first posted 8 April 2022) and the published bioaccess® Mexico country page, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics-committee, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. No principal investigator is named on this NCT location row; we will not invent one. Alcon is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Salauno clinical trial, Salauno Salud SAPI de CV Mexico City, Alcon fluid accommodating IOL Mexico, BAL-FAIOL site, or “go direct to the Mexico City site,” you followed a facility string ClinicalTrials.gov still publishes on 1 September 2026. Salauno Salud SAPI de CV is a real named ophthalmology facility on that record. It is not the operator of the COFEPRIS file.

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

This page is the intercept for the Mexico City query. It does not clone clinical trials in Mexico. That page stays the country operating system. The two other Mexican rows on this same NCT get their own slugs: Asociación Para Evitar la Ceguera en México and Centro de Retina Médica y Quirúrgica Zapopan. This slug is the Salauno legal-entity string only. Salauno is a separate organisation from APEC and from Conde de Valenciana. Do not merge them.

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

NCT05317728 is an industry device feasibility listing. Brief title: Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design. Official title: Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control. Organization study ID: ILR286-E002. Lead sponsor: Alcon Research, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed. The only overall official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. There is no central contact and no principal investigator is named on any location row — we will not invent one.

Design on the 3 September 2026 snapshot: interventional; primary purpose DEVICE_FEASIBILITY; phase N/A; Cohort 1 randomized parallel-group with participant and outcomes-assessor masking, Cohort 2 single-group unmasked; actual enrollment 175; status ACTIVE_NOT_RECRUITING. Actual start 31 March 2023; estimated primary completion and completion November 2026. Study first posted 8 April 2022; last update posted 1 September 2026. Condition: cataract.

Interventions, in the registry’s words: the BAL-FAIOL IOL, an investigational implantable medical device intended for long-term use over the lifetime of the cataract subject; a commercially available monofocal IOL control (other name AcrySof IQ monofocal IOL, SN60WF); and cataract surgery by phacoemulsification with a clear corneal incision. The oversight module records the study as an FDA-regulated device study of an unapproved device that is a U.S. export. That combination — unapproved investigational IOL, exported from the United States, run in Latin America under a feasibility purpose — is exactly the file a CRO carries.

The six location rows currently published:

• Clinica 20/20, San José, Costa Rica — already intercepted at clinica-20-20-san-jose-fih.
• Laser Center SA, Santo Domingo, Dominican Republic — already intercepted at laser-center-santo-domingo-fih.
• Centro de Retina Medica y Quirurgica SC, Zapopan, Jalisco, Mexico.
• Asociación Para Evitar la Ceguera en México, Mexico City.
• Salauno Salud SAPI de CV, Mexico City.
• Panama Eye Center, Panama City — already intercepted at panama-eye-centre-orillac-calvo-miniject.

Read the record as it is. Primary purpose is DEVICE_FEASIBILITY. The device is unapproved. Three of the six buildings are in Mexico, and until this batch none of the three had a dedicated public intercept. That is the site-direct leak: a sponsor searching a fluid-accommodating IOL, Alcon feasibility, or a Mexican ophthalmology campus lands on a named facility with no operator between them and the file.

Mexico City is a site. The CRO is the operator.

Salauno Salud SAPI de CV can provide cataract surgical volume, biometry and refractive outcome measurement, and surgeons who implant IOLs every week. That is necessary. It is not sufficient for an unapproved, U.S.-exported investigational lens a sponsor expects to defend later.

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

• Discuss surgeon interest and surgical feasibility for an investigational IOL — when that service is available and appropriate for your lens, which is not automatic.
• Share institutional ethics-committee calendars and clinic research rules.
• Quote surgery, visit, and local staffing costs for the cases they will physically run.

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

• COFEPRIS. Clinical investigations sit under the Ley General de Salud and its implementing regulations. The submission is in Spanish: protocol, investigator brochure, informed consent, ethics approval, proof of insurance. A conversation with a Monterrey dermatologist is not that dossier.
• Institutional ethics. Ethics-committee review under NOM-012-SSA3-2012 sits in front of the COFEPRIS file, and the committee is tied to the host institution once the site is chosen.
• Investigational import. Bringing an unapproved device into Mexico is a separate workstream from the trial authorization and from a later commercial registro sanitario. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a site-only premium here.
• ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. If one Mexican room is not enough, a single-clinic MSA will not stretch to Colombia, Panama, or Costa Rica.

Going direct to Salauno Salud SAPI de CV is how you confirm an operating list. It is not how you open an investigational file.

Site versus CRO

How COFEPRIS and ethics sit next to the clinic

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

• Ethics at 4–6 weeks under NOM-012-SSA3-2012; COFEPRIS review at 4–8 weeks after ethics clearance; 2.8-month median start-up (attributed on that hub to NIH ClinRegs).
• Published per-patient range $18,000–$30,000; 10+ pre-qualified sites across Mexico City, Guadalajara, and Monterrey.
• The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada — a commercial market-access clock, not this trial clock.
• All COFEPRIS submissions are in Spanish, including protocol, investigator brochure, and informed consent.
• Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not a guarantee of clearance or approval.
• bioaccess®’s published cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study.

We will not invent a facility-only day count. Ask for a protocol-specific calendar. A clinic email is not a COFEPRIS authorization.

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

• Device: BAL-FAIOL fluid-accommodating intraocular lens, investigational and implantable, versus an AcrySof IQ SN60WF monofocal control, as described on NCT05317728.
• Sponsor: Alcon Research (industry). No collaborator. No CRO named.
• Site: Salauno Salud SAPI de CV — one of six published location rows.
• Design: DEVICE_FEASIBILITY, phase N/A, actual n=175, ACTIVE_NOT_RECRUITING, actual start 31 March 2023, estimated completion November 2026.
• Regulatory flags on the record: FDA-regulated device; unapproved device; U.S. export.
• Not claimed here: that the NCT named bioaccess®; that Alcon is a bioaccess® client; that we have BAL-FAIOL outcomes; that a named investigator exists on this row when the registry prints none; that this facility is the same building as any sibling intercept.

What the CRO still does after you have a clinic name

• Regulatory-fit, not tourism. Mexico is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet — in Spanish.
• Importer of record and device accountability across every activated row.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality across Costa Rica, the Dominican Republic, Panama, Colombia, and the rest of the platform when one campus is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background on why registry rows keep outranking operators: ClinicalTrials.gov FIH sites vs the CRO and LATAM FIH hospitals vs the CRO.

Frequently asked questions

Can I contract Salauno Salud SAPI de CV directly?

You can try. The facility can discuss surgeon interest, local case costs, and ethics-committee calendars. It cannot become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Alcon listed it on a registry row. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the Alcon fluid-accommodating IOL study?

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

Who is the principal investigator at this site?

The registry does not name one on this location row, and neither will we. The only official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. A page that invents a surgeon name to look authoritative is a page a sponsor should not trust.

The study is ACTIVE_NOT_RECRUITING. Why does this page exist?

Because the row is still published and still ranks. Sponsors planning the next feasibility IOL study search the campus strings on the last one. Enrollment status changes; the search behaviour does not.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Mexican ophthalmology search is not an instruction to abandon INVIMA. See CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT05317728 (last update posted 1 September 2026; first posted 8 April 2022) and the published bioaccess® Mexico country page, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics-committee, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. No principal investigator is named on this NCT location row; we will not invent one. Alcon is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Asociación Para Evitar la Ceguera en México clinical trial, APEC Mexico City IOL study, Alcon fluid accommodating IOL Mexico, BAL-FAIOL site, or “go direct to the Mexico City site,” you followed a facility string ClinicalTrials.gov still publishes on 1 September 2026. Asociación Para Evitar la Ceguera en México is a real named ophthalmology facility on that record. It is not the operator of the COFEPRIS file.

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

This page is the intercept for the Mexico City query. It does not clone clinical trials in Mexico. That page stays the country operating system. Sibling Mexico City intercepts stay on their own buildings: Instituto de Oftalmología Conde de Valenciana. The two other Mexican rows on this same NCT get their own slugs: Salauno Salud and Centro de Retina Médica y Quirúrgica Zapopan. This slug is the APEC campus string only. It is not CODET Vision Institute Tijuana and it is not Conde de Valenciana. Do not merge them.

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

NCT05317728 is an industry device feasibility listing. Brief title: Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design. Official title: Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control. Organization study ID: ILR286-E002. Lead sponsor: Alcon Research, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed. The only overall official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. There is no central contact and no principal investigator is named on any location row — we will not invent one.

Design on the 3 September 2026 snapshot: interventional; primary purpose DEVICE_FEASIBILITY; phase N/A; Cohort 1 randomized parallel-group with participant and outcomes-assessor masking, Cohort 2 single-group unmasked; actual enrollment 175; status ACTIVE_NOT_RECRUITING. Actual start 31 March 2023; estimated primary completion and completion November 2026. Study first posted 8 April 2022; last update posted 1 September 2026. Condition: cataract.

Interventions, in the registry’s words: the BAL-FAIOL IOL, an investigational implantable medical device intended for long-term use over the lifetime of the cataract subject; a commercially available monofocal IOL control (other name AcrySof IQ monofocal IOL, SN60WF); and cataract surgery by phacoemulsification with a clear corneal incision. The oversight module records the study as an FDA-regulated device study of an unapproved device that is a U.S. export. That combination — unapproved investigational IOL, exported from the United States, run in Latin America under a feasibility purpose — is exactly the file a CRO carries.

The six location rows currently published:

• Clinica 20/20, San José, Costa Rica — already intercepted at clinica-20-20-san-jose-fih.
• Laser Center SA, Santo Domingo, Dominican Republic — already intercepted at laser-center-santo-domingo-fih.
• Centro de Retina Medica y Quirurgica SC, Zapopan, Jalisco, Mexico.
• Asociación Para Evitar la Ceguera en México, Mexico City.
• Salauno Salud SAPI de CV, Mexico City.
• Panama Eye Center, Panama City — already intercepted at panama-eye-centre-orillac-calvo-miniject.

Read the record as it is. Primary purpose is DEVICE_FEASIBILITY. The device is unapproved. Three of the six buildings are in Mexico, and until this batch none of the three had a dedicated public intercept. That is the site-direct leak: a sponsor searching a fluid-accommodating IOL, Alcon feasibility, or a Mexican ophthalmology campus lands on a named facility with no operator between them and the file.

Mexico City is a site. The CRO is the operator.

Asociación Para Evitar la Ceguera en México can provide cataract surgical volume, biometry and refractive outcome measurement, and surgeons who implant IOLs every week. That is necessary. It is not sufficient for an unapproved, U.S.-exported investigational lens a sponsor expects to defend later.

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

• Discuss surgeon interest and surgical feasibility for an investigational IOL — when that service is available and appropriate for your lens, which is not automatic.
• Share institutional ethics-committee calendars and clinic research rules.
• Quote surgery, visit, and local staffing costs for the cases they will physically run.

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

• COFEPRIS. Clinical investigations sit under the Ley General de Salud and its implementing regulations. The submission is in Spanish: protocol, investigator brochure, informed consent, ethics approval, proof of insurance. A conversation with a Monterrey dermatologist is not that dossier.
• Institutional ethics. Ethics-committee review under NOM-012-SSA3-2012 sits in front of the COFEPRIS file, and the committee is tied to the host institution once the site is chosen.
• Investigational import. Bringing an unapproved device into Mexico is a separate workstream from the trial authorization and from a later commercial registro sanitario. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a site-only premium here.
• ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. If one Mexican room is not enough, a single-clinic MSA will not stretch to Colombia, Panama, or Costa Rica.

Going direct to Asociación Para Evitar la Ceguera en México is how you confirm an operating list. It is not how you open an investigational file.

Site versus CRO

How COFEPRIS and ethics sit next to the clinic

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

• Ethics at 4–6 weeks under NOM-012-SSA3-2012; COFEPRIS review at 4–8 weeks after ethics clearance; 2.8-month median start-up (attributed on that hub to NIH ClinRegs).
• Published per-patient range $18,000–$30,000; 10+ pre-qualified sites across Mexico City, Guadalajara, and Monterrey.
• The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada — a commercial market-access clock, not this trial clock.
• All COFEPRIS submissions are in Spanish, including protocol, investigator brochure, and informed consent.
• Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not a guarantee of clearance or approval.
• bioaccess®’s published cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study.

We will not invent a facility-only day count. Ask for a protocol-specific calendar. A clinic email is not a COFEPRIS authorization.

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

• Device: BAL-FAIOL fluid-accommodating intraocular lens, investigational and implantable, versus an AcrySof IQ SN60WF monofocal control, as described on NCT05317728.
• Sponsor: Alcon Research (industry). No collaborator. No CRO named.
• Site: Asociación Para Evitar la Ceguera en México — one of six published location rows.
• Design: DEVICE_FEASIBILITY, phase N/A, actual n=175, ACTIVE_NOT_RECRUITING, actual start 31 March 2023, estimated completion November 2026.
• Regulatory flags on the record: FDA-regulated device; unapproved device; U.S. export.
• Not claimed here: that the NCT named bioaccess®; that Alcon is a bioaccess® client; that we have BAL-FAIOL outcomes; that a named investigator exists on this row when the registry prints none; that this facility is the same building as any sibling intercept.

What the CRO still does after you have a clinic name

• Regulatory-fit, not tourism. Mexico is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet — in Spanish.
• Importer of record and device accountability across every activated row.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality across Costa Rica, the Dominican Republic, Panama, Colombia, and the rest of the platform when one campus is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background on why registry rows keep outranking operators: ClinicalTrials.gov FIH sites vs the CRO and LATAM FIH hospitals vs the CRO.

Frequently asked questions

Can I contract Asociación Para Evitar la Ceguera en México directly?

You can try. The facility can discuss surgeon interest, local case costs, and ethics-committee calendars. It cannot become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Alcon listed it on a registry row. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the Alcon fluid-accommodating IOL study?

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

Who is the principal investigator at this site?

The registry does not name one on this location row, and neither will we. The only official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. A page that invents a surgeon name to look authoritative is a page a sponsor should not trust.

The study is ACTIVE_NOT_RECRUITING. Why does this page exist?

Because the row is still published and still ranks. Sponsors planning the next feasibility IOL study search the campus strings on the last one. Enrollment status changes; the search behaviour does not.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Mexican ophthalmology search is not an instruction to abandon INVIMA. See CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT07802431 (study first posted 3 September 2026; last update posted 3 September 2026) and the published bioaccess® Mexico country page, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics-committee, and FDA rules with qualified advisers. We name only the facility, the investigator, and the trial those sources support. We do not publish site contact emails or phone numbers here. Jeisys Medical is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Especialistas de la Piel y Cirugía clinical trial, Jeisys Linear Z Mexico, LinearZ HIFU body contouring study, Hector Leal Leal Monterrey, or “go direct to the Monterrey site,” you followed a facility string ClinicalTrials.gov published for the first time on 3 September 2026. Especialistas de la Piel y Cirugía, S.C. in Monterrey, Nuevo León is a real named facility on that record. It is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: Especialistas de la Piel y Cirugía is the site. The First-in-Human CRO still owns COFEPRIS, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if Monterrey is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A recruiting location row does not become a CRO.

This page is the intercept for the Monterrey query. It does not clone clinical trials in Mexico. That page stays the country operating system. Sibling Mexican intercepts stay on their own buildings: Centro de Dermatología de Monterrey, CODET Vision Institute Tijuana, and Instituto de Oftalmología Conde de Valenciana. Do not merge them into this slug.

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

NCT07802431 is a brand-new industry device listing. The registry’s own dates, retrieved 3 September 2026: study first submitted 27 August 2026; QC submitted 1 September 2026; first posted 3 September 2026; last update posted 3 September 2026. Brief title: Clinical Evaluation of Linear Z for Body Contouring. Official title: Prospective, Single-center, Single-arm Clinical Research Evaluating the Safety and Effectiveness of Linear Z for Non-invasive Body Contouring of the Abdomen and Flanks. Organization study ID: LIN-BD-01-2026. Lead sponsor: Jeisys Medical Inc, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed.

Design on the 3 September 2026 snapshot: interventional; single-center, single-arm; allocation N/A; no masking; primary purpose treatment; phase N/A; estimated enrollment 30; status RECRUITING. Estimated start 1 September 2026; estimated primary completion 20 December 2026; estimated completion 31 December 2026. Condition: non-invasive body contouring. Registry keywords: body contouring; high-intensity focused ultrasound (HIFU); localized adiposity; fat reduction.

Intervention, in the registry’s words: a device — high intensity focused ultrasound. Participants receive a single treatment with the LinearZ focused ultrasound device to the lower abdomen and bilateral flanks, delivered at specific depths within subcutaneous tissue per the sponsor-approved treatment manual, with roughly 90 days of follow-up. The registry’s oversight module records no data monitoring committee, and marks the study as not FDA-regulated drug and not FDA-regulated device — a sponsor-entered flag about this listing, not a statement about what a later U.S. filing would require.

Location rows currently published:

• Especialistas de la Piel y Cirugía, S.C. — the only location on the record — RECRUITING. The registry prints the geography as city “Nuevo León,” state “Monterrey,” ZIP 64060, Mexico. We report that as published; the two fields appear transposed on the row and we will not silently rewrite a sponsor’s entry.
• Named site contact on that row: Hector Leal Leal, Dr. Central contact on the record: Narendra Kumar, Dr., PhD, Jeisys. We do not reprint their direct contact details here.

Read the record as it is. A single Mexican site, an estimated 30 participants, a 90-day endpoint window, an industry sponsor in Korea, and no CRO in the public copy. That is the site-direct leak: a sponsor searching LinearZ, Jeisys, or Monterrey body contouring now lands on a named clinic with no operator between them and the file.

Monterrey is a site. The CRO is the operator.

A Monterrey dermatology and surgery practice can provide treatment rooms, standardized photography and 3D imaging, subjects with localized abdominal and flank adiposity, and an investigator the registry already named. That is necessary. It is not sufficient for an investigational-device study a U.S. board expects to survive later scrutiny.

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

• Discuss investigator interest and procedural feasibility for an energy-device protocol — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and clinic research rules.
• Quote procedure, visit, and local staffing costs for the sessions they will physically run.

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

• COFEPRIS. Clinical investigations sit under the Ley General de Salud and its implementing regulations. The submission is in Spanish: protocol, investigator brochure, informed consent, ethics approval, proof of insurance. A conversation with a Monterrey dermatologist is not that dossier.
• Institutional ethics. Ethics-committee review under NOM-012-SSA3-2012 sits in front of the COFEPRIS file, and the committee is tied to the host institution once the site is chosen.
• Investigational import. Bringing an unapproved device into Mexico is a separate workstream from the trial authorization and from a later commercial registro sanitario. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a site-only premium here.
• ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. If one Mexican room is not enough, a single-clinic MSA will not stretch to Colombia, Panama, or Costa Rica.

Going direct to Especialistas de la Piel y Cirugía is how you confirm a room. It is not how you open an investigational file.

Site versus CRO

How COFEPRIS and ethics sit next to the clinic

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

• Ethics at 4–6 weeks under NOM-012-SSA3-2012; COFEPRIS review at 4–8 weeks after ethics clearance; 2.8-month median start-up (attributed on that hub to NIH ClinRegs).
• Published per-patient range $18,000–$30,000; 10+ pre-qualified sites across Mexico City, Guadalajara, and Monterrey.
• The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada — a commercial market-access clock, not this trial clock.
• All COFEPRIS submissions are in Spanish, including protocol, investigator brochure, and informed consent.
• Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not a guarantee of clearance or approval.
• bioaccess®’s published cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study.

We will not invent a facility-only day count. Ask for a protocol-specific calendar. A clinic email is not a COFEPRIS authorization.

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

• Device: LinearZ high-intensity focused ultrasound for non-invasive body contouring of the lower abdomen and flanks, as described on NCT07802431.
• Sponsor: Jeisys Medical Inc (industry). No collaborator. No CRO named.
• Site: Especialistas de la Piel y Cirugía, S.C., Monterrey / Nuevo León, Mexico — the only location row, RECRUITING.
• Design: single-center, single-arm, phase N/A; estimated n=30; estimated start 1 September 2026; ~90-day follow-up.
• Named investigator (as published): Hector Leal Leal, Dr., site contact on the location row.
• Not claimed here: that the NCT named bioaccess®; that Jeisys is a bioaccess® client; that we have LinearZ outcomes; that this listing is an FDA IDE; that the clinic holds a COFEPRIS authorization because it is printed on a registry row.

What the CRO still does after you have a clinic name

• Regulatory-fit, not tourism. Mexico is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet — in Spanish.
• Importer of record and device accountability for the investigational system.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality if one Nuevo León room is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background on why registry rows keep outranking operators: ClinicalTrials.gov FIH sites vs the CRO.

Frequently asked questions

Can I contract Especialistas de la Piel y Cirugía directly?

You can try. The facility can discuss investigator interest, local session costs, and ethics-committee calendars. It cannot become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Jeisys listed Monterrey. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the Linear Z study?

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

The registry says this is not an FDA-regulated device study. Does 21 CFR 812.28 still matter?

It matters the moment you want the data to travel. That sponsor-entered flag describes this listing. If a U.S. submission is ever the goal, the GCP, ethics, and documentation conditions in 21 CFR 812.28 are what make foreign data eligible for FDA submission and review — and eligibility is still not clearance.

Why does the record print Nuevo León as the city and Monterrey as the state?

Because that is what the sponsor entered. Monterrey is the city and Nuevo León is the state. We report the row as published and flag the transposition rather than quietly rewriting a public record.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Monterrey search is not an instruction to abandon INVIMA. See CRO in Colombia.

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

If you searched Hospital Nacional Hipolito Unanue first-in-human, Hipolito Unanue Lima clinical trial, Unanue CRO, or “go direct Hospital Nacional Hipólito Unanue,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Nacional Hipólito Unanue in Lima, Peru, is a real named national-hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the INS file.

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

This page is the named Lima Hipólito Unanue campus. Skip INEN Lima (CMS 95644) on this slug. It is not Clínica Vesalio Lima (CMS 96116), not Clínica San Borja Lima (already live), and not a DIGESA invention. Sharing Lima is not a license to collapse them. Unanue is not INEN. Unanue is not Vesalio.

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

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

Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Hospital Nacional Hipólito Unanue (Lima, Peru) — canonical NCT string: ALL interventional n=8; DEVICE n=1. Example NCT IDs: NCT00685360, NCT00868959, NCT01284517.

Cite canonical ALL n=8 and DEVICE n=1. Do not clone INEN or Vesalio onto this slug. We do not invent a Peruvian legal entity.

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 Hipólito Unanue first-in-human finds ALL n=8 (DEVICE n=1) without finding INS / DIGEMID. A named national hospital 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:

• INS. INS (DIIS, formerly OGITT) authorizes trials in Peru. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. A hallway conversation in Lima is not that stack. We will not invent DIGESA onto this page. We do not invent a Peruvian legal entity. A hallway conversation at Hipólito Unanue is not an INEN file and is not a Vesalio file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How INS actually works (the short version)

Use clinical-trials-peru. INS (DIIS, formerly OGITT) authorizes trials. A published statutory target on that hub is 40 business days in the drug-trial framework, and 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. We will not invent a new Peruvian clock on this page. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. The Peru hub already cites experience-based cost on the order of ~30% lower versus US/EU — that is a country-page figure, not a campus quote we invent here. We do not invent a Peruvian legal entity on this page.

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

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

Do not smear the hospital

Hospital Nacional Hipólito Unanue is a serious named Lima campus on the public registry. ALL n=8 and DEVICE n=1 are registry volume, not a punchline. Do not invent a PI. Do not invent DIGESA. Do not invent a Peruvian legal entity. 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 INS / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

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

Colombia is still on the map

Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital Nacional Hipólito Unanue 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 INS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as INEN Lima or Clínica Vesalio?

No. INEN Lima is CMS 95644 and stays skipped on this slug. Clínica Vesalio Lima is CMS 96116. This page is Hospital Nacional Hipólito Unanue only.

Did bioaccess® run NCT00685360?

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. Lima sibling (do not merge): Clínica Vesalio Lima.

Julio G. Martinez-Clark, CEO · bioaccess®