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Category: First-in-Human

  • FDA 21 CFR 812.28 in LATAM: foreign clinical trial inspectability for device sponsors

    FDA’s foreign clinical data rule is not a slogan. Under 21 CFR 812.28, the agency can use a well-designed, well-conducted investigation outside the United States to support an IDE or a device marketing application — and it can also show up at the site to validate the file. The question US MedTech teams should ask before first patient in Latin America is not “will FDA accept OUS data?” It is “could an English-speaking inspector reconstruct what happened here?”

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the inspectability cut of 812.28 for LATAM device trials. For the IDE-package framing, use Can OUS first-in-human data support an FDA IDE submission?. For country clocks, use the published Panama and El Salvador hubs — not a new timeline invented here.

    What 812.28 actually requires

    Section 812.28 (final rule, 83 FR 7386, 21 February 2018) says FDA will accept foreign clinical information for an IDE or a device marketing application (PMA, HDE, 510(k), or De Novo) when three conditions are met:

    1. Good clinical practice. Design, conduct, monitoring, auditing, recording, analysis, and reporting that keep data credible and protect subjects — including independent ethics-committee review before initiation, continuing review, and documented freely given informed consent. FDA has stated that conformance with ISO 14155:2020 will generally satisfy the GCP requirement of 812.28 (already on our FDA acceptance guide). Investigations initiated on or after 21 February 2019 must conform to the 2018 foreign-data framework.
    2. Supporting information in 812.28(b). For a significant-risk device under 812.3(m), submit the full (b) set: investigators and sites; protocol and results; a statement that the investigational device is identical to the US device or a detailed comparison; valid scientific evidence under 21 CFR 860.7 if you claim safety and effectiveness; IEC identity meeting 812.3(t); consent, monitoring, and investigator GCP training.
    3. Inspectability. FDA can validate the data through an onsite inspection or other appropriate means if the agency deems it necessary. A LATAM file that cannot be inspected is not an 812.28 file.

    Section 812.28(e) is the residual clause: even when a foreign study does not fully meet paragraph (a), FDA may still accept the information if it believes the data are credible and accurate and that subject rights were adequately protected. Do not plan to live in (e). Build (a).

    The failure mode I see: ethics approval without an inspectable record

    Sponsors who only chase local ethics-committee approval treat the stamp as the finish line. That buys enrollment speed. It does not buy an IDE conversation.

    Three patterns burn the file:

    • Source that cannot be reconstructed. Paper charts in a language and filing system nobody planned to reconcile. When the IDE questions arrive, you cannot show who saw what, when.
    • Device accountability that dies at customs. Investigational units imported through a commercial distributor “because they already import,” with no chain that survives explant, quarantine, and an English-speaking inspector.
    • Consent written in English and “translated later.” 812.28 wants documented consent the IEC actually approved. For FDA use, include the 21 CFR 50.25 elements. Spanish first.

    Those are the same failure modes already named on the OUS-IDE page. Inspectability is the operational layer underneath them.

    What “inspection-ready” means at a LATAM site

    Architect the study so an FDA inspector (or a CRO monitor acting for a later US filing) can walk the site without a scavenger hunt:

    • Electronic data capture with audit trails, not spreadsheet science.
    • Source documents that map to CRF fields in a single reconciliation plan — imaging, device logs, AE narratives.
    • Device accountability from import permit through implant/explant that matches the investigator brochure identity claim in 812.28(b)(5).
    • Monitoring reports that show who visited, what was queried, and what closed — not a one-page “visit done.”
    • Investigator GCP training on file before first procedure, not after the first query.
    • eTMF structure that an English-speaking reviewer can navigate: protocol versions, IEC approvals, consents, safety letters, delegation logs.

    Panama’s Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C) already puts high-risk protocols through parallel MINSA + Type II ethics review, RESEGIS registration before start, and 24-hour / 15-day serious-adverse-event clocks. That decree structure helps the local file. It does not replace the 812.28 inspectability design. Same rule for El Salvador under DNM/SRS and for any other lead FIH geography we publish: local authorization is necessary; FDA-usable documentation is a separate design choice.

    Site selection is an inspectability decision

    Pick sites and principal investigators who have already run device protocols with monitors in the room. Early-feasibility n in Panama City is typically 5–20 patients — the right size for a Class III first-in-human cohort (already on the Panama Class III FIH page). Rare disease or a larger n belongs in a multi-country plan.

    Public programs already on the FDA-acceptance guide show the pattern: Axoft FINESSE (first cases at The Panama Clinic; FDA Breakthrough Device Designation in 2022); Newrotex (ethics approval in Panama; FDA Pre-Sub for a 510(k) using LATAM data); ReGelTec HYDRAFIL (Colombia early-feasibility, then FDA IDE for a US pivotal). Those names are already public. I am not adding unpublished sponsors or devices under development.

    Colombia remains a core market-access geography. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new first-in-human trial execution. Keep commercial registro and investigational CTA tracks apart.

    Pre-Sub before you lock endpoints

    If the LATAM protocol is meant to support a later US IDE, file a Q-Sub / Pre-Sub before you lock endpoints (written feedback in 75 calendar days — already on the FDA-acceptance guide). Endpoints and inclusion criteria have to be relevant to the intended US population; site standard of care has to be comparable to US practice. Changing the device after first implant without a comparability memo makes 812.28(b)(5) unforgiving.

    One-page gate before first patient

    1. US filing intended. IDE, 510(k), De Novo, PMA, or HDE — named before country pick.
    2. Device identity claim. Identical to the US unit, or a written comparison with change control.
    3. IEC + local authority path. Type II / national desk as the country requires — not an ad-hoc hospital chat.
    4. Spanish consent with 21 CFR 50.25 elements if FDA use is the plan.
    5. EDC + eTMF + device accountability that survive an English-speaking inspector.
    6. Monitoring plan with query closure ownership before first implant.

    If you are staring at a LATAM first-in-human calendar and a future FDA conversation, send bioaccess® the protocol stage, device risk class, intended US filing, and whether the investigational unit is identical to the US unit. We will tell you whether the file is being built for 812.28(a) or for a case series.

    Related: FIH without waiting years for FDA, clinical trials, and the LATAM site network.

  • Clinical trial execution in Colombia: why we recommend it now

    Colombia is now in scope for bioaccess® clinical-trial execution across all phases — first-in-human through pivotal — for both medical devices and drugs, in every indication. That is a reversal of our prior position, and the reason is that the regulator changed faster than the market narrative about it did.

    INVIMA is one of eight national authorities certified by PAHO as a Regional Reference Regulatory Authority at Level IV, the highest level PAHO assigns for medicines regulation and surveillance in the Americas (INVIMA, Cooperación internacional; PAHO, Autoridades Regulatorias de Referencia). Since 2022 it has built a dedicated clinical-research group for devices, published its own approval and non-approval registries, and opened a public study search. Sponsors are still pricing Colombia on 2018 assumptions.

    What changed since 2022

    Three institutional facts, all documented by INVIMA itself.

    First, devices got their own clinical-research function: INVIMA created the Grupo de Investigación Clínica y Apoyo a Sala Especializada DMRDIV (GICASE) through Resolución 2022035262 of 20 September 2022 (INVIMA, Investigación Clínica — Dispositivos). Second, the Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV) now has an explicit mandate to evaluate and issue technical and methodological opinions on research protocols involving devices and in vitro diagnostic reagents (INVIMA, Sala especializada DMRDIV). Device sponsors have a named technical body, not an improvised one.

    Third, INVIMA publishes what it approves and what it refuses: a register of device clinical studies approved from 2021 onward, a parallel register of studies not approved with the reason for each — non-approval, withdrawal, pending response — and a register of ethics-committee and research-site inspection status to November 2025 (INVIMA, Investigación Clínica — Dispositivos; register of non-approved device studies). Very few regulators in the region publish their rejections, and that register shows which protocol defects cost applicants a cycle. INVIMA’s public study search lists 1,157 clinical studies, 1,156 of them approved, 487 in progress and 523 completed, with a data date of 12 August 2026 (INVIMA, Lista de Estudios Clínicos).

    The device pathway: prototype authorization through pivotal

    Colombia has no single device clinical-trial regulation. It has three working instruments, and knowing which one carries which obligation is most of the job.

    Decreto 4725 de 2005 is the sanitary regime for human-use medical devices. Article 2 defines a device intended for clinical investigation as one used by a specialist physician in research in an appropriate human clinical setting. Article 36 provides that a national or imported prototype device — or controlled-technology biomedical equipment — may be authorized only for research and experimentation, may not be used in health care, and requires an INVIMA technical opinion. Article 48(b) is the import hook: exceptional importation without sanitary registration or commercialization permit where the device is the subject of clinical research authorized in Colombia, subject to a prior opinion from the relevant specialized chamber. Article 18(k) closes the loop commercially — class IIb and III devices must present clinical studies to demonstrate safety and effectiveness when they later seek Registro Sanitario (Decreto 4725 de 2005).

    Resolución 8430 de 1993 supplies the human-subjects framework — the scientific, technical and administrative rules for health research, including new prophylactic, diagnostic, therapeutic and rehabilitative resources (MinSalud) — and INVIMA names it as the governing instrument for research with human beings.

    The operative paperwork is form-driven and published: ASS-RSA-FM085 (checklist for the prototype-device technical-opinion request), ASS-RSA-FM172 (SEDMRDIV technical-opinion request), ASS-RSA-FM169 (initial study evaluation completed by the ethics committee), ASS-RSA-FM170 (periodic reports) and ASS-RSA-FM171 (serious adverse event notification) (INVIMA, Investigación Clínica — Dispositivos). There is no ambiguity about what to file. There is considerable skill in filing it in a form the SEDMRDIV will not bounce.

    The drug pathway

    For medicines the anchor is Resolución 2378 de 2008, which adopted Good Clinical Practices with mandatory application for institutions conducting research with medicines in human beings (INS, Resolución 2378 de 2008). INVIMA requires approval for Phase I, II and III protocols and for Phase IV protocols with intervention; non-interventional Phase IV studies must still be submitted with a summary so INVIMA can determine whether formal approval applies (INVIMA, Fiscalización de Ensayos Clínicos).

    Initial protocol evaluation is filed through Protocolos en Línea, the exclusive route for that procedure since 2 January 2020, under tariff 4070 for protocols and 4083 for amendments; adverse-event content and periodicity are set by Resolución 2011020764 de 2011, issued under Article 146 of Decreto 677 de 1995 (INVIMA, Fiscalización de Ensayos Clínicos).

    Import of unregistered investigational medicines runs through Article 96 of Decreto 677 de 1995, which lets INVIMA exceptionally authorize importation without sanitary registration where INVIMA or the Ministry has authorized clinical research in the country, following a Comisión Revisora opinion and against a free-sale certificate, corporate documentation and analysis-fee receipts (Decreto 677 de 1995). Where the investigational product is a controlled substance, the monopoly is administered by the Fondo Nacional de Estupefacientes, and INVIMA expressly prioritizes those files in its current contingency plan (Resolución 2025046281 de 2025). Sponsors sometimes look for a separate narcotics department in the trial pathway; the correct counterparty is the FNE, and only for controlled product.

    Timelines, and what the misconception gets wrong

    The complaint about Colombia is that it is slow and unpredictable. Half of that is true.

    Protocol volume has been flat for a decade — roughly 90 protocol-evaluation requests a year, 85 in 2014 and 87 in 2024 — and INVIMA’s average time to a definitive concept, approving or rejecting, is 5.1 months (ConsultorSalud, June 2025). Five months to a decision is not fast. It is a measured average with a published rejection register behind it, which makes it forecastable — unpredictability is the charge that does not survive contact with the data.

    Country Published regulatory clock for trial authorization Source
    Colombia No statutory day-count; measured 5.1-month average to a definitive INVIMA concept ConsultorSalud
    Argentina Disposición ANMAT 7516/2025 Art. 5 assigns evaluation to the Dirección de Investigación Clínica, states no day-count Boletín Oficial
    Chile ISP: 45 business days to authorize import of unregistered pharmaceutical products for trial use ISP Chile
    Panama Decreto Ejecutivo 21 de 2026 regulates Títulos III–IV of Ley 84 de 2019; no day-count published MINSA Panamá

    Three of the four comparators publish no binding clock at all. Colombia’s disadvantage on early-phase device work is smaller than the reputation suggests, and Colombia is the only one of the four that publishes both its approvals and its refusals.

    Sites: Bogotá, Medellín, Cali

    Colombia’s population was estimated at 53 million in 2025 (DANE, July 2025), and by December 2024 more than 160 centres held INVIMA Good Clinical Practice certification (ConsultorSalud).

    INVIMA’s own register of approved research ethics committees places them in Bogotá, Medellín, Cali, Floridablanca and Montería, attached to established IPS and medical foundations (INVIMA, CEI list to May 2025). Bogotá, Medellín and Cali are the tier-1 clusters — high-volume tertiary hospitals, certified pharmacy and clinical-laboratory services inside the same certified institution, and investigator populations that read English protocols without translation. Floridablanca (Santander) and Montería extend regional recruitment reach.

    Ethics committees

    A Colombian trial needs a CEI approved by INVIMA and a site holding a current BPC certificate. That certificate is issued to the IPS after INVIMA verifies compliance with Resolución 2378 de 2008 through inspection visits, runs for five years, and requires evidence that the institution is registered under the Sistema Único de Habilitación with authorized pharmaceutical service, clinical laboratory and sample-collection services (INVIMA, Certificaciones en BPC). Replacing a site’s ethics committee is a formal BPC modification requiring a new-conditions verification visit and a written transfer plan agreed with sponsor, CRO and both committees. Sponsors who treat CEI selection as an afterthought lose weeks here.

    Post-trial access in Colombia

    Colombia does not currently mandate post-trial access by statute. Resolución 2378 de 2008 and Resolución 8430 de 1993 were both read in full for post-trial supply language and neither contains it; Resolución 8430 allocates only harm-related costs (Arts. 13, 15(j)–(k), 58(c)). bioaccess® can operate voluntary continuity programs in Colombia on sponsor request. Statutory PTA mandates in Latin America currently apply to Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras and Nicaragua — not Colombia.

    What is coming, and why it favours moving now

    Three reform tracks are live. A draft unified sanitary regime would replace Decreto 4725 de 2005 and Decreto 3770 de 2004, adding conditional indefinite authorizations, international reliance mechanisms, mandatory UDI from first filing, four IVD risk classes on IMDRF parameters and an 18-month transition; it cleared national consultation and went to WTO public consultation (ConsultorSalud, June 2026). MinSalud has circulated a draft resolution on health research with human beings that would partially repeal Resolución 8430 de 1993 (ConsultorSalud, February 2026). And a clinical-research framework bill filed in the Cámara in August 2025 by Senator Fabián Díaz Plata and Representative Juan Daniel Peñuela Calvache would adopt ICH E6 and ISO 14155:2020 as the regulatory standard, create an INVIMA registry of authorized CROs and accredited investigators, and impose tacit approval — INVIMA objects within 7 calendar days for common-risk research and 30 for high-risk research, with ratification in a further 5 days (Cámara de Representantes, bill text). It classifies first-in-human studies and novel implantable devices as high-risk.

    None is law yet. All three point the same direction, and each rewards sponsors who already hold Colombian sites, a certified CEI relationship and an INVIMA filing history when a transition period starts.

    Registro Sanitario sits at the far end of the same pathway

    Registro Sanitario is the INVIMA marketing authorization that lets a device be sold in Colombia, granted under Decreto 4725 de 2005 with technical evaluation under Article 18 and legal evaluation under Article 19; INVIMA may issue one request for additional information, with 90 days to respond, and BPM and CCAA certificates run for five years (Decreto 4725 de 2005). bioaccess® already runs Registro Sanitario market access in Colombia, and the reason to place trial and registration with one operator is Article 18(k): the clinical evidence a class IIb or III sponsor generates in Colombia is the evidence its Colombian registration will later be judged on.

    Planning a first-in-human or pivotal trial in Colombia? bioaccess® is a US-headquartered, LATAM-native operator running regulatory submissions, importadora functions and 2–8 °C GDP cold chain across the region, and Colombia is now in scope for all phases, all indications, devices and drugs. To discuss INVIMA feasibility, site selection in Bogotá, Medellín or Cali, or a combined trial-plus-Registro-Sanitario pathway, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    Does bioaccess® conduct clinical trials in Colombia?
    Yes. As of September 2026 Colombia is in scope for bioaccess® clinical-trial execution across all phases, from first-in-human through pivotal, in all indications, for both medical devices and drugs. This is a change from our earlier position. The reversal follows documented institutional improvement at INVIMA since 2022 — a dedicated device clinical-research group, a named specialized chamber for device protocols, published approval and non-approval registries, and a public study search — combined with our own operating capability in Bogotá, Medellín and Cali. bioaccess® also runs INVIMA Registro Sanitario market access in Colombia, so the trial and the eventual marketing authorization can be sequenced by one operator.

    What is INVIMA’s role in Colombian clinical trials?
    INVIMA authorizes, monitors and can halt clinical research in Colombia. It evaluates both clinical aspects and the quality of the investigational product, requires approval for Phase I, II and III protocols and for interventional Phase IV protocols, and requires submission of non-interventional Phase IV studies so it can determine whether formal approval applies. It may interrupt an investigation or require modifications at any time if authorization conditions change, Good Clinical Practice is not met, or participant or public-health protection requires it. Sponsor-to-CRO delegations must be reported to INVIMA and remain the sponsor’s responsibility.

    What is the INVIMA clinical-trial pathway for medical devices?
    Three instruments combine. Decreto 4725 de 2005 Article 36 authorizes prototype devices for research and experimentation only, against an INVIMA technical opinion; Article 48(b) permits exceptional importation without sanitary registration where the device is the subject of clinical research authorized in Colombia, following a prior opinion from the specialized chamber; Article 18(k) later requires clinical studies for class IIb and III Registro Sanitario. Resolución 8430 de 1993 supplies the human-subjects rules. The SEDMRDIV issues the technical and methodological opinion, supported since September 2022 by the GICASE group created under Resolución 2022035262.

    What is the INVIMA clinical-trial pathway for drugs?
    Resolución 2378 de 2008 adopted Good Clinical Practices with mandatory application for institutions researching medicines in humans, and is the basis of the site BPC certificate. Initial protocol evaluation is filed through INVIMA’s Protocolos en Línea platform, exclusive for that procedure since 2 January 2020, under tariff 4070 for protocols and 4083 for amendments. Adverse-event reporting content and periodicity follow Resolución 2011020764 de 2011, issued under Article 146 of Decreto 677 de 1995. Importation of unregistered investigational medicines runs under Article 96 of Decreto 677 de 1995 with a Comisión Revisora opinion. Controlled substances involve the Fondo Nacional de Estupefacientes, which administers that monopoly.

    What are typical INVIMA authorization timelines in 2026?
    There is no statutory day-count in force for protocol authorization. The measured figure is an average of 5.1 months from filing to a definitive INVIMA concept, approving or rejecting, against a stable volume of roughly 90 protocol-evaluation requests a year. Sponsors should plan the ethics-committee approval, the INVIMA concept and the import authorization as sequential rather than parallel steps. The clinical-research bill filed in August 2025 would replace the current position with tacit approval — 7 calendar days for common-risk and 30 for high-risk studies — but it is not law.

    Does Colombia require post-trial access?
    No. Colombia does not currently mandate post-trial access by statute. Resolución 2378 de 2008 and Resolución 8430 de 1993 contain no post-trial supply obligation; Resolución 8430 allocates only harm-related costs. bioaccess® can operate voluntary continuity programs in Colombia on sponsor request, governed by the protocol, the informed consent and the ethics committee’s expectations rather than by statute. Statutory PTA mandates in Latin America currently apply to Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras and Nicaragua.

    What is INVIMA Registro Sanitario?
    Registro Sanitario is the INVIMA authorization required to market a medical device in Colombia, granted under Decreto 4725 de 2005 following technical evaluation under Article 18 and legal evaluation under Article 19. INVIMA may issue one request for additional or clarifying information, and the applicant has 90 days to respond before the file is deemed abandoned. Manufacturing and storage certificates — BPM and CCAA — are valid for five years. For class IIb and III devices, Article 18(k) requires clinical studies demonstrating safety and effectiveness, which is why trial design and registration strategy belong in the same plan.

    Which Colombian cities have the best clinical-trial infrastructure?
    Bogotá, Medellín and Cali are the tier-1 clusters, and INVIMA’s own register of approved ethics committees places committees in those three cities plus Floridablanca and Montería, attached to established IPS and medical foundations. More than 160 centres held INVIMA Good Clinical Practice certification as of December 2024. The practical selection criterion is not city size but whether the certified institution holds authorized pharmaceutical service, clinical laboratory and sample-collection services inside the same habilitación, because a contracted service adds documentation to every BPC modification.

    How does Colombia compare to Argentina, Panama and Chile for early-phase device trials?
    On published regulatory clocks, three of the four disclose nothing binding. Argentina’s Disposición 7516/2025 Article 5 assigns protocol evaluation to ANMAT’s Dirección de Investigación Clínica without stating a day-count. Panama’s Decreto Ejecutivo 21 of 23 April 2026 regulates Títulos III and IV of Ley 84 de 2019 with no authorization day-count on the MINSA page. Chile’s ISP publishes 45 business days for the resolution authorizing import of unregistered pharmaceutical products for trial use. Colombia publishes no clock but has a measured 5.1-month average and, unlike the other three, publishes both its approvals and its refusals for device studies.

    What has changed at INVIMA since 2022?
    Resolución 2022035262 of 20 September 2022 created the GICASE group for device clinical research and support to the specialized chamber. The SEDMRDIV now carries an explicit mandate to evaluate device and IVD research protocols. INVIMA publishes registers of approved device studies, non-approved device studies with reasons, SEDMRDIV import authorizations for observational studies, and ethics-committee and site inspection status to November 2025. Its public study search reported 1,157 studies with a data date of 12 August 2026. INVIMA also remains one of eight PAHO Level IV Regional Reference Regulatory Authorities.

    Sources

    • INVIMA — Cooperación internacional (PAHO Level IV ARNr status): https://www.invima.gov.co/el-instituto/cooperacion-internacional
    • PAHO/OPS — Autoridades Regulatorias de Referencia: https://www.paho.org/es/autoridades-regulatorias-referencia
    • INVIMA — Investigación Clínica, Dispositivos (GICASE, Resolución 2022035262 de 2022, forms ASS-RSA-FM085/169/170/171/172, published registers): https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/investigacion-clinica
    • INVIMA — Sala especializada de dispositivos médicos y reactivos de diagnóstico in vitro: https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/sala-especializada-dispositivos-reactivos
    • INVIMA — Registro de estudios clínicos con dispositivos médicos no aprobados 2021–2025: https://www.invima.gov.co/biblioteca/registro-estudios-clinicos-dispositivos-medicos-no-aprobados-invima-2021-2025
    • INVIMA — Lista de Estudios Clínicos (public study search, data date 12 August 2026): https://www.invima.gov.co/estudios
    • INVIMA — Fiscalización de Ensayos Clínicos, Medicamentos (Protocolos en Línea, tariffs 4070/4083, Resolución 2011020764 de 2011): https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/medicamentos-de-sintesis-quimica-y-biologica/ensayos-clinicos
    • INVIMA — Procesos de certificación en Buenas Prácticas Clínicas (BPC certificate, 5-year validity): https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/medicamentos-de-sintesis-quimica-y-biologica/licenciamiento-auditorias-y-certificaciones/certificaciones-en-buenas-practicas
    • INVIMA — Listado de Comités de Ética en Investigación aprobados a mayo 2025: https://www.invima.gov.co/biblioteca/comites-etica-investigacion-aprobados-invima-2025
    • Decreto 4725 de 2005 (Arts. 2, 18, 19, 21, 22, 36, 48, 89) — Función Pública, Gestor Normativo: https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=18697
    • Decreto 677 de 1995 (Art. 96 exceptional import; Arts. 145–146) — INVIMA normograma: https://normograma.invima.gov.co/compilacion/docs/decreto_0677_1995.htm
    • Resolución 2378 de 2008 (Buenas Prácticas Clínicas) — Instituto Nacional de Salud: https://www.ins.gov.co/Normatividad/Resoluciones/RESOLUCION%202378%20DE%202008.pdf
    • Resolución 8430 de 1993 — MinSalud: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/de/dij/resolucion-8430-DE-1993.PDF
    • Resolución INVIMA 2025046281 de 19 de septiembre de 2025 (contingency plan; Fondo Nacional de Estupefacientes prioritization): http://normograma.invima.gov.co/normograma/compilacion/docs/resolucion_invima_46281_2025.htm
    • Resolución INVIMA 2025010547 de 19 de marzo de 2025 (Plan de Contingencia): https://normograma.invima.gov.co/compilacion/docs/resolucion_invima_10547_2025.htm
    • DANE — Nota Técnica, Proyecciones de Población, July 2025 (53 million in 2025): https://www.dane.gov.co/files/censo2018/proyecciones-de-poblacion/Nacional/NotaTecnica-PPED-jul2025.pdf
    • Cámara de Representantes — clinical-research framework bill, August 2025 (tacit approval 7/30 days, ICH E6, ISO 14155:2020): https://hcrpruebas.camara.gov.co/wp-content/uploads/2025/08/proyectos_ley/25082025_25082025_ver_documento_17.pdf
    • ConsultorSalud, 25 June 2025 — INVIMA average 5.1 months to definitive concept; ~90 protocols/year; 160+ BPC-certified centres: https://consultorsalud.com/colombia-reto-regulacion-estudios-clinicos/
    • ConsultorSalud, June 2026 — draft unified medical device sanitary regime replacing Decretos 4725/2005 and 3770/2004: https://consultorsalud.com/regimen-unico-dispositivos-medicos-impactos/
    • ConsultorSalud, February 2026 — MinSalud draft resolution partially repealing Resolución 8430 de 1993: https://consultorsalud.com/minsalud-investigacion-salud-seres-humanos-ips/
    • Disposición ANMAT 7516/2025, Art. 5 — Boletín Oficial de la República Argentina: https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
    • Instituto de Salud Pública de Chile — 45 business days for trial import authorization: https://www.ispch.gob.cl/pregunta-frecuente/p-141/
    • MINSA Panamá — Decreto Ejecutivo N° 21 de 23 de abril de 2026: https://www.minsa.gob.pa/normatividad/decreto-ejecutivo-ndeg-21-jueves-23-de-abril-2026-que-reglamenta-los-titulos-iii-y-iv
    • bioaccess® — Colombia clinical trial regulatory guide: https://bioaccessla.com/regulatory-guide/colombia

  • FIH cost in Panama or El Salvador vs the US: use published clocks, not invented averages

    Boards ask a cost question that is really a calendar question: how much does a first-in-human medical device trial in Panama or El Salvador cost versus the United States? The honest answer is not a single invoice line. It is which clock you are buying — evidence versus domestic site contracting — and which numbers are already published on bioaccess® country hubs versus numbers nobody should invent on a blog.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page uses only figures and clocks already live on bioaccessla.com. It is not a quote. Confirm study-specific budgets with a proposal.

    What “vs the US” usually means

    When founders say the U.S. FIH is “too expensive,” they often mean three stacked costs:

    • Time to first patient — site contracting, IRB sequencing, and treating first implant as a United States-only problem. That is the year the FIH-without-waiting-for-FDA article already names — not the 30-day IDE review clock alone.
    • Per-patient and site economics — published LATAM bands versus a U.S. academic stack you have not actually bid yet.
    • Evidence quality for later FDA use — ISO 14155 discipline and 21 CFR § 812.28 design, or you bought cheap subjects you cannot spend.

    A Latin America investigation is not a discount coupon on FDA. It is a second evidence calendar that can run while the U.S. path is still being built.

    Published Panama clocks and bands

    Panama is a published lead Class III FIH geography under MINSA and the Comité Nacional de Bioética de la Investigación (CNBI), on Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026 — already detailed on the Panama Class III FIH guide.

    • Ethics band already published on country comparisons: Panama ethics about 3–5 weeks versus Colombia about 4–6 weeks (live comparison cited on Dominican Republic and Colombia holder pages that point at clinical-trials-panama).
    • Per-patient band already published: about USD 12,000–22,000 per patient in Panama versus about USD 15,000–25,000 in Colombia on that same published comparison. Those are hub figures, not a new tariff invented here.
    • Dollarized economy, English-capable sites, investigation units only — commercial registro stays a separate MINSA market-access file. Do not put a selling license number on FIH freight.

    I will not invent a “typical U.S. per-patient” dollar figure on this page. If your U.S. sites have not returned a real budget, you do not have a US comparator — you have a hope.

    Published El Salvador clocks

    El Salvador’s public study-startup language is a 30–60 day band for CNEIS ethics plus SRS clinical-investigation authorization. That band is not a DNM/SRS commercial registro. The sibling post on CNEIS/SRS trial vs DNM registro exists because sponsors keep merging the two clocks and then “comparing cost” against a U.S. IDE that was never the same petition.

    Cost discipline in El Salvador starts with keeping the investigation file off the commercial holder track. Mixing them creates rework that erases any calendar advantage.

    What to put in the board slide (instead of one fake total)

    1. Evidence column. Lead FIH jurisdiction (Panama MINSA/CNBI or El Salvador CNEIS/SRS), ethics desk, investigational importer, § 812.28 owner, ISO 14155 TMF owner.
    2. Published LATAM bands only. Use the Panama per-patient and ethics figures above when Panama is in scope. Ask for a study-specific quote before you present a single program total.
    3. U.S. column as real bids. Site budgets, IRB fees, and contracting lead times from named U.S. sites — or leave the cell blank. Blank is more honest than a blogger’s invented US average.
    4. Commercial column (optional). Holder / IOR countries on the market-access hub. Already-cleared launch is a different SKU from FIH.

    Where “cheap LATAM” burns money

    • Thin TMF. Speed without ISO 14155 monitoring, device accountability, and ethics correspondence buys investor slides and FDA friction.
    • One Gantt bar for FIH and registro. El Salvador’s 30–60 day language is the clearest public warning.
    • Country tourism. Five ethics desks because a slide said “LATAM” dilutes the file.
    • Invented US baselines. Comparing Panama’s published USD 12K–22K band to a made-up “US is $80K” number is not diligence.

    Colombia note (do not flip the public line)

    Colombia remains a strong market-access geography and a historical FIH geography for bioaccess®. The public line still stands: INVIMA clinical-trial approval timelines have become unpredictable, so bioaccess® does not currently recommend Colombia for new first-in-human execution. Use Panama, El Salvador, Chile, or the Dominican Republic when the protocol needs a lead investigation desk — and keep INVIMA registro on the commercial track.

    Insurance and import are line items, not optional footnotes

    Ethics packets in Panama and El Salvador still want financial responsibility for participant injury documented before initiation — Spanish certificate language is the usual ask. That is a coverage exhibit, not a product-liability rider someone forwarded from a U.S. policy. The live insurance intercepts already warn that a master excluding the country fails ethics, and that product liability is not clinical-trial liability. Budget the certificate with the CRO and a licensed broker before you present “LATAM is cheaper.”

    Investigational import is another line that disappears from naive US-vs-LATAM spreadsheets. Name the importer for investigation units. Do not put a cousin commercial registro number on FIH freight — that pattern burns weeks at customs and contaminates both tracks. The parallel-calendar article already lists that failure mode; cost models that ignore it are fiction.

    How bioaccess® talks about program-level savings

    Across Latin America FIH hubs, bioaccess® has long published experience-based language of roughly 30% lower program cost and about 40% faster versus typical US/EU baselines since 2010 — as experience, not a formal study (already on Dominican Republic and LATAM FIH benchmark language). Treat that as orientation, not a guarantee for your Class III implant with a thin TMF. Study-specific quotes beat blog averages.

    Practical next step

    This week, rewrite the cost slide as three columns: published LATAM evidence calendar, real U.S. site bids (or blank), commercial holder countries if any. Start from the Panama Class III FIH guide or the El Salvador clinical-trials hub for column one. If you need a study-specific number, bring protocol stage, device class, and sample size — bioaccess® will quote the investigation without inventing a U.S. average to win the comparison.

  • Reina Madre Mexico City: The NCT Facility String Is Not the COFEPRIS File

    Reina Madre Mexico City: The NCT Facility String Is Not the COFEPRIS File

    Reina Madre in Mexico City, Mexico, is a separate named facility string in the public record.

    General information, not legal or regulatory advice. This page cites a public ClinicalTrials.gov facility row. It does not claim that bioaccess® ran the study, that the facility is a client, or that the registry record is a first-in-human device authorization.

    When a sponsor searches a facility name, the search result can look like a complete clinical-development answer. It is not. A site can contribute investigators, rooms, coordinators, recruitment, and protocol-specific operations. The sponsor still needs the study strategy, contracts, ethics submission, data systems, monitoring, safety reporting, insurance, and the applicable regulatory file. A facility string is not a CRO.

    The public record used here is ClinicalTrials.gov study NCT06581068. The record describes an industry-sponsored study involving IVF-lab automation and lists facilities in Mexico City. The registry is evidence that the facility string appears in a public study record. It is not evidence of a bioaccess® engagement, an endorsement, a completed outcome, or a regulatory clearance.

    What the facility can do

    • Assess whether the protocol fits its patient flow, laboratory capability, staffing, and local research procedures.
    • Discuss investigator interest, site feasibility, visit logistics, and institutional review steps.
    • Provide site-specific costs and operational requirements for the work it will physically perform.

    What the facility row does not establish

    • It does not establish that the facility is the sponsor, CRO, importer of record, insurer, or regulatory applicant.
    • It does not establish the identity or qualifications of a principal investigator beyond whatever the public record itself displays.
    • It does not establish that a treatment-validation study is a first-in-human medical-device study.
    • It does not replace a protocol-specific feasibility review, agreement, or regulatory assessment.

    Mexico City is a site decision, not the whole start-up plan

    For work in Mexico, a sponsor should separate institutional ethics and operational planning from the COFEPRIS pathway. Trial authorization, investigational import, insurance, monitoring, electronic data capture, adverse-event reporting, and the later sanitary registration question are different workstreams. A site email can help answer a local feasibility question. It cannot by itself open the national file or create a quality system.

    bioaccess® can assess the country and protocol fit, coordinate the regulatory and site-start-up work, and keep the operating responsibilities explicit. The correct sequence is to confirm the protocol, identify the required site capabilities, document feasibility, agree the scope, and then activate the facility if it fits. The page is not a claim that either named facility is a signed bioaccess® partner.

    About the registry record

    NCT06581068 is cited here because it is the public source for the facility association. Registry records can change, use facility aliases, and describe a study purpose that is not the same as a sponsor’s later device-regulatory plan. Read the current record directly before making a decision. Do not infer clinical performance, patient outcomes, regulatory status, or commercial availability from a facility name.

    Frequently asked questions

    Did bioaccess® run NCT06581068?

    No. This page cites a public facility row only. We will not invent a client relationship, investigator role, outcome, or sponsor claim.

    Can a sponsor contract the facility directly?

    A sponsor can discuss site interest and local operations with a facility. That discussion is not a substitute for the CRO, regulatory, safety, data, insurance, and multi-country responsibilities the protocol may require.

    Is this a regulatory approval?

    No. A ClinicalTrials.gov listing is not COFEPRIS authorization, ethics approval, import permission, or sanitary registration.

    What is the next step?

    Start with a protocol-specific feasibility and country-fit review. Then define the regulatory, site, monitoring, data, safety, insurance, and import workstreams before activation.

    bioaccess® does not name either facility as a signed partner here. We use the public record to answer a search, not to invent a relationship.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • New Hope Fertility Centre Mexico City: The NCT Facility String Is Not the COFEPRIS File

    New Hope Fertility Centre Mexico City: The NCT Facility String Is Not the COFEPRIS File

    New Hope Fertility Centre in Mexico City, Mexico, is a named facility string in the public record.

    General information, not legal or regulatory advice. This page cites a public ClinicalTrials.gov facility row. It does not claim that bioaccess® ran the study, that the facility is a client, or that the registry record is a first-in-human device authorization.

    When a sponsor searches a facility name, the search result can look like a complete clinical-development answer. It is not. A site can contribute investigators, rooms, coordinators, recruitment, and protocol-specific operations. The sponsor still needs the study strategy, contracts, ethics submission, data systems, monitoring, safety reporting, insurance, and the applicable regulatory file. A facility string is not a CRO.

    The public record used here is ClinicalTrials.gov study NCT06581068. The record describes an industry-sponsored study involving IVF-lab automation and lists facilities in Mexico City. The registry is evidence that the facility string appears in a public study record. It is not evidence of a bioaccess® engagement, an endorsement, a completed outcome, or a regulatory clearance.

    What the facility can do

    • Assess whether the protocol fits its patient flow, laboratory capability, staffing, and local research procedures.
    • Discuss investigator interest, site feasibility, visit logistics, and institutional review steps.
    • Provide site-specific costs and operational requirements for the work it will physically perform.

    What the facility row does not establish

    • It does not establish that the facility is the sponsor, CRO, importer of record, insurer, or regulatory applicant.
    • It does not establish the identity or qualifications of a principal investigator beyond whatever the public record itself displays.
    • It does not establish that a treatment-validation study is a first-in-human medical-device study.
    • It does not replace a protocol-specific feasibility review, agreement, or regulatory assessment.

    Mexico City is a site decision, not the whole start-up plan

    For work in Mexico, a sponsor should separate institutional ethics and operational planning from the COFEPRIS pathway. Trial authorization, investigational import, insurance, monitoring, electronic data capture, adverse-event reporting, and the later sanitary registration question are different workstreams. A site email can help answer a local feasibility question. It cannot by itself open the national file or create a quality system.

    bioaccess® can assess the country and protocol fit, coordinate the regulatory and site-start-up work, and keep the operating responsibilities explicit. The correct sequence is to confirm the protocol, identify the required site capabilities, document feasibility, agree the scope, and then activate the facility if it fits. The page is not a claim that either named facility is a signed bioaccess® partner.

    About the registry record

    NCT06581068 is cited here because it is the public source for the facility association. Registry records can change, use facility aliases, and describe a study purpose that is not the same as a sponsor’s later device-regulatory plan. Read the current record directly before making a decision. Do not infer clinical performance, patient outcomes, regulatory status, or commercial availability from a facility name.

    Frequently asked questions

    Did bioaccess® run NCT06581068?

    No. This page cites a public facility row only. We will not invent a client relationship, investigator role, outcome, or sponsor claim.

    Can a sponsor contract the facility directly?

    A sponsor can discuss site interest and local operations with a facility. That discussion is not a substitute for the CRO, regulatory, safety, data, insurance, and multi-country responsibilities the protocol may require.

    Is this a regulatory approval?

    No. A ClinicalTrials.gov listing is not COFEPRIS authorization, ethics approval, import permission, or sanitary registration.

    What is the next step?

    Start with a protocol-specific feasibility and country-fit review. Then define the regulatory, site, monitoring, data, safety, insurance, and import workstreams before activation.

    bioaccess® does not name either facility as a signed partner here. We use the public record to answer a search, not to invent a relationship.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Dr. Juan Osorio, Chondrograft FIH Principal Investigator in Panamá: The Named PI Is Not the MINSA File

    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

    Workstream What the named investigator and hospital typically own What the CRO still owns
    Procedure Mini-arthrotomy or arthroscopic implantation, imaging, follow-up exams Protocol fit, training, implant accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by being named as PI MINSA / CNBI file
    Import Receiving and storage if contracted Importer of record for the investigational implant
    Quality Source documents from the cases performed ISO 14155 monitoring, EDC, AE reporting, TMF
    FDA conversation Clinical judgement and case data 21 CFR 812.28 narrative — eligibility, not clearance
    Scale-up One surgical team in Panama City Second country, pivotal readiness, Colombia (INVIMA) and the rest of the platform

    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.

  • Centro de Intervenciones Cardiovasculares Santiago de los Caballeros: Named Akura ATC Site, Not the DIGEMAPS File

    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

    Workstream What the Santiago centre (site) typically owns What the CRO still owns
    Procedure Cath lab, PE pathway, imaging, local staff Protocol fit, training, device accountability and resupply logistics
    Ethics Institutional REC calendar and local rules Packet, ICF, IB alignment, deficiency cycle under CONABIOS oversight
    National authority Not the permit holder by being listed on an NCT DIGEMAPS clinical-trial file
    Import Receiving and storage if contracted Importer of record for an unapproved, U.S.-exported system
    Quality Hospital quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One Santiago building (plus two São Paulo rows on the same NCT) Colombia (INVIMA), Panama, and the rest of the bioaccess® platform

    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.

  • Centro de Retina Médica y Quirúrgica Zapopan: Named Alcon Feasibility IOL Site, Not the COFEPRIS File

    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:

    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

    Workstream What the Zapopan retina centre (site) typically owns What the CRO still owns
    Procedure OR list, phacoemulsification, biometry, refractive follow-up, local staff Protocol fit, surgeon training, investigational IOL accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle (NOM-012-SSA3-2012)
    National authority Not the permit holder by being listed on an NCT COFEPRIS clinical-investigation file, in Spanish
    Import Receiving and storage if contracted Importer of record for an unapproved, U.S.-exported lens
    Quality Clinic quality and the case ISO 14155 monitoring, EDC, AE reporting, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One building on a six-site record Colombia (INVIMA) and the rest of the bioaccess® platform

    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.

  • Salauno Salud Mexico City: Named Alcon Feasibility IOL Site, Not the COFEPRIS File

    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:

    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

    Workstream What Salauno (site) typically owns What the CRO still owns
    Procedure OR list, phacoemulsification, biometry, refractive follow-up, local staff Protocol fit, surgeon training, investigational IOL accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle (NOM-012-SSA3-2012)
    National authority Not the permit holder by being listed on an NCT COFEPRIS clinical-investigation file, in Spanish
    Import Receiving and storage if contracted Importer of record for an unapproved, U.S.-exported lens
    Quality Clinic quality and the case ISO 14155 monitoring, EDC, AE reporting, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One building on a six-site record Colombia (INVIMA) and the rest of the bioaccess® platform

    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.

  • Asociación Para Evitar la Ceguera en México: Named Alcon Feasibility IOL Site, Not the COFEPRIS File

    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:

    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

    Workstream What the APEC campus (site) typically owns What the CRO still owns
    Procedure OR list, phacoemulsification, biometry, refractive follow-up, local staff Protocol fit, surgeon training, investigational IOL accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle (NOM-012-SSA3-2012)
    National authority Not the permit holder by being listed on an NCT COFEPRIS clinical-investigation file, in Spanish
    Import Receiving and storage if contracted Importer of record for an unapproved, U.S.-exported lens
    Quality Clinic quality and the case ISO 14155 monitoring, EDC, AE reporting, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One building on a six-site record Colombia (INVIMA) and the rest of the bioaccess® platform

    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.