Category: Navigating Regulatory Landscapes in Latin America

General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.

If you searched Bioforum Israel FIH device CRO, Bioforum medical device first-in-human, Bioforum Pi-Cardia LATAM, you were looking for a first-in-human / early-feasibility medical-device CRO in Israel. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.

Bioforum is on the named AU/IL/CA set because it is a data-focused CRO with a Melbourne office and an Israel base. Locked device-adjacent cases are biometrics, not bioaccess®-style hospital FIH ops. Pi-Cardia ShortCut™ (leaflet-modification for valve-in-valve TAVR) is named, FDA-cleared, Breakthrough Device; Bioforum’s published role is data / stats / FDA package; EU → US site expansion on that page; not an Australia ops case. ShortCut itself is cleared — do not pitch a redo. Steal is Pi-Cardia’s next leaflet / valve-in-valve / next-gen EFS operations in LATAM if that protocol exists. We will not invent it onto this page as if it were already signed.

This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Israel if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.

What this search is actually buying

Ibex Prostate Detect is a named AI/SaMD 510(k) client (stats + data management + site monitoring on Bioforum’s congratulations page; Ibex also notes TGA and ANVISA registrations on its own clearance copy). Already cleared. Steal would be a LATAM clinical-performance / next-indication study, and only if that study is a true early device protocol — not a 510(k) follow-on we pad into a five-trial goal. MeMed BV® on MeMed Key® is a named host-response IVD (FDA 510(k) Sep 2021); Bioforum role is EDC + CEC + CSR. Country of APOLLO sites is not stated on the Bioforum page. Asset already cleared.

What is excluded on purpose

Abiomed Impella post-approval data partnership (from Jun 2019; PAS figures are Abiomed’s published numbers, not a Bioforum FIH). Dren Bio DR-01 is a drug EDC case. Neither is an Israel hospital-implant FIH we can steal. We will not add extra CRO brands. We will not name NextLife.

Israel-only NCT rows are the sibling page

This intercept is the Bioforum operator. Israel-only or Canada-only device NCT geography is the combined second-country page — one page, not a ninth. Do not split it.

Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA

A data CRO package does not import an investigational implant into Panama. If the next protocol needs ISO 14155 field-clinical in Latin America, that is a different operator. Country 2 is not a new Colombian FIH CTA.

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

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

Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.

Colombia stays market access

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.

What bioaccess® still owns on the steal

1. ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
2. Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
3. Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
4. 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
5. No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.

The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.

Frequently asked questions

Is bioaccess® trying to replace the incumbent CRO on a live protocol?

No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.

Do you sell clinical trial insurance on this page?

No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.

Is Colombia the country-2 default?

No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.

Next step

If the search that brought you here was Bioforum Israel as the FIH device CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling NCT page: Israel- or Canada-only NCT → LATAM.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.

If you searched GreenLight Clinical Australia FIH CRO, GreenLight Clinical Sydney medical device, GreenLight Clinical first-in-human, you were looking for a first-in-human / early-feasibility medical-device CRO in Australia. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.

GreenLight Clinical is the Sydney CRO. This page is never Greenlight Guru, never Christine, never an EDC SKU. Locked 28 Aug and 1 Sep 2026: the therapeutic-areas page claims medical-device + FIH experience. The homepage names Surface Ophthalmics (C-100-001 / C-200-001) — ophthalmic drug (SURF-100/200). No named device case study and no sponsor+device URL was found. Capability copy is not a stealable hospital-implant FIH.

This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Australia if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.

What this search is actually buying

Device founders land here because “GreenLight” + “Australia” + “FIH” is a crowded query. If you meant the eQMS/EDC vendor, you are on the wrong site and we will not route you there. If you meant the Sydney CRO for a device EFS, there is no public named device protocol to steal from. The intercept is still country 2: Latin America for the protocol that capability copy cannot show.

Named client on the public site is drug

Surface Ophthalmics is not an implant EFS. We will not recast SURF-100/200 as a device. We will not invent a GreenLight Clinical neurovascular or structural-heart case. We will not scrape Guru Clinical customer stories (Loop Medical, InnoCon, Medartis) onto this AU CRO page — those are not AU/IL/CA FIH steal targets for this job.

Do not merge Avania, Novotech, and GreenLight Clinical

Avania publishes unnamed AU device FIH cases. Novotech publishes drug FIH cases. GreenLight Clinical publishes capability plus a named drug client. Three slugs. Three jobs. Do not write a mega-CRO smear. Do not add extra brands.

Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA

A Sydney capability page is not MINSA clearance and not ISO 14155 monitoring in Panama. If the device still needs first human data that can travel toward an FDA IDE, use the live LATAM hubs. Do not wait for a GreenLight device case study to appear.

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

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

Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.

Colombia stays market access

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.

What bioaccess® still owns on the steal

1. ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
2. Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
3. Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
4. 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
5. No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.

The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.

Frequently asked questions

Is bioaccess® trying to replace the incumbent CRO on a live protocol?

No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.

Do you sell clinical trial insurance on this page?

No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.

Is Colombia the country-2 default?

No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.

Next step

If the search that brought you here was GreenLight Clinical Australia as the FIH CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Siblings: Novotech AU, Avania AU.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.

If you searched Novotech Australia FIH CRO, Novotech first-in-human medical device Australia, Novotech Sydney device EFS, you were looking for a first-in-human / early-feasibility medical-device CRO in Australia. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.

Novotech is a Sydney-founded regional mega-CRO. Device sponsors type the name because Australia-as-country-1 is a slide they have already seen. Honest hedge, locked on 28 Aug 2026 and re-checked 1 Sep 2026: Novotech’s public case-study hub is drug FIH. 2026 pages include a complex GMO oncology trial (AU + US, FPFD 2 Dec 2025), FIH mRNA immunotherapy across APAC, and Phase I/II oncology start-up in Australia for a China biotech (May 2026). Older DiaMedica Phase I is drug. No device case study was found on the hub. This page still exists because the search is real. We will not invent a Novotech device FIH to fill the gap.

This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Australia if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.

What this search is actually buying

If you are a drug sponsor, this is the wrong operator. If you are a device sponsor who Googled Novotech because CTN + R&DTI is the Australia story, country 2 is a Latin American hospital-implant stack, not a second Novotech work order we invent. Do not count GMO, mRNA, or DiaMedica toward a device five-trial goal.

What we will not do with Novotech’s named drug FIHs

ReveraGen, PharmAbcine, DiaMedica, Botanix and other names that appear on drug case pages are not medical-device EFS. We will not re-skin them as implants. We will not imply Novotech ran an unnamed stent, valve, or liquid embolic in Australia. If a future public Novotech page names a true device FIH/EFS, that is a later refresh — not this intercept.

Why a device founder still uses this search

Australia-first is sold on speed and incentives. A device still needs ISO 14155, implant or interventional sites, import, and a 21 CFR 812.28 story. A mega-CRO drug Phase I unit is not that. GreenLight Clinical is a different AU CRO intercept. Avania is the AU shop actually publishing device FIH cases. Do not merge the three brands.

Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA

Keep Australia if it is already running. Add Panama, Chile, Brazil, Mexico, or El Salvador for the n that will not wait on another CTN. Do not default to a new Colombian FIH.

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

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

Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.

Colombia stays market access

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.

What bioaccess® still owns on the steal

1. ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
2. Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
3. Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
4. 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
5. No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.

The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.

Frequently asked questions

Is bioaccess® trying to replace the incumbent CRO on a live protocol?

No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.

Do you sell clinical trial insurance on this page?

No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.

Is Colombia the country-2 default?

No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.

Next step

If the search that brought you here was Novotech Australia as the FIH CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Siblings: Avania AU, GreenLight Clinical AU.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.

If you searched Avania Canada FIH device CRO, Avania Unity Health Toronto Remedy N1, Avania Health Canada first-in-human, you were looking for a first-in-human / early-feasibility medical-device CRO in Canada. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.

The only named Avania-Canada device FIH we will put on a public page from the locked 1 Sep 2026 keeper is Remedy Robotics and the investigational Remedy N1 endovascular surgical robot. FIH at Unity Health Toronto: St. Michael’s Hospital (patients) and St. Joseph’s Health Centre (operator), led publicly by Vitor Mendes Pereira, MD. Company and press describe fully remote neurointerventional FIH (Oct 2025) and an earlier Nov 2024 fully robotic neurointerventional procedure in a human. Avania’s success-stories page is the CRO + Health Canada / FDA submissions partner (David Bell testimonial). Device still investigational / not for sale. We will not invent other named Canadian Avania sponsors onto this page.

This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Canada if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.

What this search is actually buying

You searched Avania Canada because a hospital-robot or neurointerventional FIH is already sitting in Toronto. The steal is not ripping Unity Health out of a live protocol. The steal is the next geography, the pivotal n, or a Latin American satellite that does not wait on another Health Canada CTA cycle. bioaccess® does not claim the Remedy study. We do not email from this page. Existing jmclark outreach to that company is a separate HOLD — not a public CTA.

Locked facts only

Legal name Remedy Robotics, Inc. HQ described as San Francisco on the Oct 6, 2025 PR Newswire and company jobs copy. Device: Remedy N1, remotely operable endovascular surgical robot (neuro / cardiovascular). CRO: Avania, clinical trial with Unity Health; Health Canada + FDA submissions. We will not treat aggregator street addresses as verified HQ. We will not publish a mailbox on this page. We will not add Turing Medical, SoundBite, or anonymous Avania blurbs as if they were Canadian named FIHs.

What country 2 looks like for a remote endovascular robot

A second-country protocol still needs ethics, import, radiation/cath-lab credentialing where the device needs it, ISO 14155 monitoring, and an SAE clock. Unity Health is not a Latin American importer of record. A Health Canada authorization is not MINSA, ISP, ANVISA, or COFEPRIS. If the next n is in Panama, Chile, Brazil, Mexico, or El Salvador, that is a new stack. We will not invent a Canadian clock here. Use the live LATAM hubs cited below.

Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA

Canada-only NCT rows are the sibling intercept. This page is the Avania-Canada operator. Do not clone leftover-site hospital pages. Do not mix Magical BTK. Do not name HDI.

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

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

Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.

Colombia stays market access

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.

What bioaccess® still owns on the steal

1. ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
2. Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
3. Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
4. 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
5. No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.

The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.

Frequently asked questions

Is bioaccess® trying to replace the incumbent CRO on a live protocol?

No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.

Do you sell clinical trial insurance on this page?

No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.

Is Colombia the country-2 default?

No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.

Next step

If the search that brought you here was Avania Canada as the FIH device CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling: Avania Australia. Combined IL/CA NCT intercept: Israel- or Canada-only NCT → LATAM.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.

If you searched Avania Australia FIH medical device CRO, Avania Melbourne Sydney first-in-human implant, cSDH liquid embolic FIH Australia, you were looking for a first-in-human / early-feasibility medical-device CRO in Australia. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.

Avania is a global MedTech CRO with Melbourne and Sydney offices. It is on this page because it is the shop actually publishing Australian hospital-implant FIH cases — not because we invented a boutique. Public Avania neurovascular copy describes a liquid-embolic cSDH first-in-human with Australia ethics and regulatory “within 3 months” (company claim) and multicenter expansion started. The sponsor on that page is unnamed. We will not infer it. The steal is the expansion, the next neurovascular FIH, or the next implant protocol that would otherwise stay in ANZ because Avania already ran the first cases.

This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Australia if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.

What this search is actually buying

You are not buying an Australian tax incentive. You are buying ISO 14155 hospital implant ops, ethics, import, and an n that can travel toward an FDA IDE. Avania’s public pitch on the unnamed PDAC implantable paclitaxel-device FIH is KOLs plus tax incentives and an Australia-first start that later “advanced to global Phase II.” Current Phase I is locked. Steal is Phase II LATAM sites or the next implant-combo protocol. Do not invent that sponsor either — several paclitaxel-device programs exist; similarity is not proof.

What the locked Avania AU cases actually say

Locked source: the 28 Aug 2026 CRO case-study steal list, public Avania therapeutic-area pages. Rank 1 is the unnamed cSDH liquid-embolic FIH (Australia ethics/regulatory + enrollment stated). Rank 2 is the unnamed PDAC implantable FIH labelled FIH / Phase I, Australia initial study. Rank 3 is the only named-sponsor AU implant FIH in that month’s set: Alessa Therapeutics Biolen-PC (bicalutamide-eluting silicone implant), NCT04284761, AU+NZ, primary completion 3 May 2023 on ClinicalTrials.gov. That study is finished. It is historic next-protocol only. We will not flip Alessa into a live steal mail from this page. USANZ named Avania on that study; Alessa’s own enrollment release did not. Quote the public pages, not a hallway.

What we will not invent

We will not name the cSDH sponsor. We will not name the PDAC sponsor. We will not infer Capstan, Versa, or any other public TMVR onto Avania’s unnamed TMVR EFS (that case is Europe + United States on Avania’s cardiovascular page — not this Australia intercept). We will not add NextLife. We will not add Greenlight Guru. Avania’s late/post-market rows (flow-diverter PMA, Quanta 510(k), hydrogel embolic stats) are not FIH steals. Nanochon stays HOLD.

Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA

If Australia already enrolled the first n, country 2 is a Latin American satellite or the next protocol — Panama ethics typically 3–5 weeks and protocol-to-first-patient 6–8 weeks on the live Panama hub; Chile ISP on the order of 30 business days for study review; Brazil combined ethics + ANVISA typically 6–10 weeks under Law 14874 / RDC 837/2023; Mexico ethics 4–6 weeks and COFEPRIS 4–8 weeks after ethics on the live Mexico hub. No AU entity. No R&DTI wait. Do not book a second CTN just because Avania is already in Melbourne.

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

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

Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.

Colombia stays market access

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.

What bioaccess® still owns on the steal

1. ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
2. Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
3. Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
4. 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
5. No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.

The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.

Frequently asked questions

Is bioaccess® trying to replace the incumbent CRO on a live protocol?

No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.

Do you sell clinical trial insurance on this page?

No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.

Is Colombia the country-2 default?

No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.

Next step

If the search that brought you here was Avania Australia as the FIH medical-device CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling (do not clone): Avania Canada. Country-2 NCT intercept: Australia-only NCT → LATAM.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not insurance, legal, or regulatory advice. Confirm current ethics / national authority ethics, import, and coverage rules with qualified advisers and a licensed broker. We do not invent premiums, limits, or carrier rates on this page. We do not claim a named carrier as a signed bioaccess® partner here. No patient data. No unpublished client. Always bioaccess®.

If you searched how US startup binds trial coverage before first LATAM SIV, insurance before site initiation visit FIH, bind clinical trial policy before SIV, you were looking for someone who would write international clinical-trial coverage for an investigational device. bioaccess® is a first-in-human medical-device CRO. We are not an insurance carrier. We do not underwrite policies. We do not sell premiums. We do not quote a binder. OUS and Latin American device trials still need trial-specific liability — local admitted paper, a master with local certificates, or both. We run the trial under ISO 14155. We can introduce a specialty carrier. That introduction is not a signed partnership on this page, and it is not a quote.

SIV is site initiation. It is late. Ethics already met. Import may already be in process. A US startup that waits for SIV to bind trial-liability has already missed the certificate gate. Batch 2’s “before first site” page is country-and-specimen sequencing. This page is the SIV clock: bind and certificate before anyone flies to the site.

This page is not a clone of Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. That hub is the country-snapshot checklist (territory, named insureds, language, runoff). This page is the binder-before-SIV sequencing for a US device startup intercept. Distinct slug. Distinct title. Same operator: the CRO runs the trial; a carrier writes the paper.

The CRO is not the carrier

Founders type “buy clinical trial insurance” and land on CROs, brokers, and hospital MSAs in the same result set. Those are three jobs:

• Carrier. Underwrites participant injury, medical expenses for trial-related events, defense, and site/investigator indemnification — if the form matches the protocol. A hallway conversation is not a binder.
• Broker. Places the form, translations, additional-insured endorsements, and territory wording. Licensed where the paper has to sit.
• CRO. Protocol, IB, ICF, ethics/ethics / national authority packet, importer of record for clinical trial devices in Latin America, ISO 14155 monitoring, SAE clock, TMF, and the 21 CFR 812.28 narrative. See OUS FIH and FDA IDE. Eligibility of foreign data is not FDA clearance.

Mixing those jobs is how a startup buys a U.S. product-liability rider, emails a PDF to an ethics committee, and gets a resubmission. Product liability is not clinical-trial liability. A site’s institutional policy is not the sponsor’s trial form.

SIV is not the insurance milestone

Typical order that actually works: protocol and IB, carrier specimen, ethics packet with certificate, approval, import, SIV, first patient. Flipping the last two with insurance is the failure mode. Trainers on site cannot invent a certificate. A hospital corridor is not a binder. We will not invent a day-count from bind to SIV.

What “bind” means — and who does it

Bind is the carrier’s yes, usually via a licensed broker. bioaccess® does not bind. We do not sell policies. We tell you the certificate has to exist before SIV because ethics already asked for it. A US CGL “worldwide” footer is not a bind for Panama. A Delaware self-insurance letter is not a bind unless the committee accepted a guarantee in writing — we will not invent that yes. Exploratory carrier introductions stay exploratory until Julio says otherwise. No HDI partnership claim. No invented rates.

What ethics and ethics / national authority actually ask for

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance. Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

Insurance documentation is usually in the ethics / ethics / national authority packet, not a post-approval formality. Typical asks (confirm with the reviewing body — we will not invent a pan-regional limit):

• Territory that names every country on the protocol.
• Site and principal investigator as additional insureds when the committee requires it.
• Policy period through last-patient last-visit plus the protocol follow-up window.
• Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
• Claims-notice language that can sit next to the SAE clock, not against it.

We will not invent a per-participant dollar figure on this page. Individual ethics committees set thresholds. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

If the master binds in the US, the local certificate still has to exist before the ethics date, which is before SIV. If local admitted paper binds in-country, start that workstream at protocol lock, not at flight booking.

A “controlled master” that never issues a local certificate is a slide, not a submission. A local-only policy that cannot travel to a second Latin American country is a one-country trap. The operator chooses geography for the device; the paper has to follow the protocol, not the other way around.

What bioaccess® still owns after you have a quote

1. Regulatory-fit, not tourism. First LATAM SIV may be Panama, Colombia, Mexico, or Chile. Territory on the bind has to name that country. bioaccess® still runs trials in Colombia. Do not skip INVIMA paper because SIV is in Panama.
2. Protocol, IB, ICF, and the ethics / ethics / national authority packet with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. Introducing a specialty carrier when the founder does not already have admitted paper. Introduction is not a signed partnership on this page. We do not invent rates.

The firm was founded in 2010. Public device case studies (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as already published) show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting. We will not invent a premium from those pages.

Colombia is still on the map

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

A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. That does not flip the public line. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs.

Frequently asked questions

Does bioaccess® sell clinical trial insurance?

No. We are the FIH CRO. We can introduce a carrier. We do not underwrite. We do not bind. We do not invent a rate card on this page.

Is this the same article as the LATAM insurance hub?

No. The hub is Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. This page is binder-before-SIV sequencing for a US device startup. Do not treat them as clones.

Can a U.S. product-liability policy cover a LATAM device FIH?

Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.

Did bioaccess® underwrite the Avantec / Sangria™ $10M policy mentioned on public pages?

No. Public llms.txt copy says bioaccess® ran FIH execution that included placing a $10M clinical-trial insurance policy as an operational workstream. That is CRO coordination, not underwriting. It is not a SKU. It is not a rate we invent here.

Next step

If the search that brought you here was how a US startup binds coverage before the first LATAM SIV, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling: before the first site. Operator: First-in-Human CRO.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not insurance, legal, or regulatory advice. Confirm current ethics / national authority ethics, import, and coverage rules with qualified advisers and a licensed broker. We do not invent premiums, limits, or carrier rates on this page. We do not claim a named carrier as a signed bioaccess® partner here. No patient data. No unpublished client. Always bioaccess®.

If you searched admitted local paper vs freedom of services clinical trial, FoS certificate LATAM trial insurance, non-admitted trial policy ethics, you were looking for someone who would write international clinical-trial coverage for an investigational device. bioaccess® is a first-in-human medical-device CRO. We are not an insurance carrier. We do not underwrite policies. We do not sell premiums. We do not quote a binder. OUS and Latin American device trials still need trial-specific liability — local admitted paper, a master with local certificates, or both. We run the trial under ISO 14155. We can introduce a specialty carrier. That introduction is not a signed partnership on this page, and it is not a quote.

European freedom-of-services certificates and non-admitted manuscripts show up in LATAM ethics folders because a European or London broker already had them. A CNBI, CONEP, or INVIMA-side clerk did not ask for FoS. They asked for a certificate they can file. FoS is an EEA passporting story. Latin America is not the EEA. bioaccess® will not pretend otherwise.

This page is not a clone of Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. That hub is the country-snapshot checklist (territory, named insureds, language, runoff). This page is the local admitted paper versus FoS/non-admitted certificates intercept. Distinct slug. Distinct title. Same operator: the CRO runs the trial; a carrier writes the paper.

The CRO is not the carrier

Founders type “buy clinical trial insurance” and land on CROs, brokers, and hospital MSAs in the same result set. Those are three jobs:

• Carrier. Underwrites participant injury, medical expenses for trial-related events, defense, and site/investigator indemnification — if the form matches the protocol. A hallway conversation is not a binder.
• Broker. Places the form, translations, additional-insured endorsements, and territory wording. Licensed where the paper has to sit.
• CRO. Protocol, IB, ICF, ethics/ethics / national authority packet, importer of record for clinical trial devices in Latin America, ISO 14155 monitoring, SAE clock, TMF, and the 21 CFR 812.28 narrative. See OUS FIH and FDA IDE. Eligibility of foreign data is not FDA clearance.

Mixing those jobs is how a startup buys a U.S. product-liability rider, emails a PDF to an ethics committee, and gets a resubmission. Product liability is not clinical-trial liability. A site’s institutional policy is not the sponsor’s trial form.

Do not import EEA passporting onto a Panama packet

Freedom of services lets some EEA carriers certificate across member states. It does not automatically create a Panamanian, Colombian, Brazilian, or Mexican admitted policy. If the committee wants locally admitted paper, an FoS PDF is a resubmission. If the committee will accept a certificate from a non-admitted or manuscript program, get that in writing. We will not invent a country-by-country admitted-paper table here.

This is not the ISO-manuscript intercept and not the master intercept

Batch 2 ISO-style vs local admitted is CMS slug iso-trial-policy-vs-local-admitted. Batch 1 master vs local is 95976. This page is FoS/passporting versus admitted. Three distinct buyer searches. Same rule: the CRO is not the carrier; we do not bind; we do not name HDI or Crowe as partners.

What ethics and ethics / national authority actually ask for

Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams. Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

Insurance documentation is usually in the ethics / ethics / national authority packet, not a post-approval formality. Typical asks (confirm with the reviewing body — we will not invent a pan-regional limit):

• Territory that names every country on the protocol.
• Site and principal investigator as additional insureds when the committee requires it.
• Policy period through last-patient last-visit plus the protocol follow-up window.
• Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
• Claims-notice language that can sit next to the SAE clock, not against it.

We will not invent a per-participant dollar figure on this page. Individual ethics committees set thresholds. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

Ask the broker which license the paper sits on in the country of ethics. If they answer with an EEA directive, ask again for Latin America. Introduction to a specialty carrier who will certificate the protocol country is an operator step, not a quote.

A “controlled master” that never issues a local certificate is a slide, not a submission. A local-only policy that cannot travel to a second Latin American country is a one-country trap. The operator chooses geography for the device; the paper has to follow the protocol, not the other way around.

What bioaccess® still owns after you have a quote

1. Regulatory-fit, not tourism. Colombia still wants financial responsibility on INVIMA-side ethics. That is not FoS. bioaccess® still runs trials in Colombia.
2. Protocol, IB, ICF, and the ethics / ethics / national authority packet with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. Introducing a specialty carrier when the founder does not already have admitted paper. Introduction is not a signed partnership on this page. We do not invent rates.

The firm was founded in 2010. Public device case studies (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as already published) show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting. We will not invent a premium from those pages.

Colombia is still on the map

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

A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. That does not flip the public line. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs.

Frequently asked questions

Does bioaccess® sell clinical trial insurance?

No. We are the FIH CRO. We can introduce a carrier. We do not underwrite. We do not bind. We do not invent a rate card on this page.

Is this the same article as the LATAM insurance hub?

No. The hub is Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. This page is local admitted paper versus FoS/non-admitted certificates. Do not treat them as clones.

Can a U.S. product-liability policy cover a LATAM device FIH?

Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.

Did bioaccess® underwrite the Avantec / Sangria™ $10M policy mentioned on public pages?

No. Public llms.txt copy says bioaccess® ran FIH execution that included placing a $10M clinical-trial insurance policy as an operational workstream. That is CRO coordination, not underwriting. It is not a SKU. It is not a rate we invent here.

Next step

If the search that brought you here was admitted local paper vs freedom-of-services for LATAM FIH, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling: ISO-style vs local admitted. Hub: Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not insurance, legal, or regulatory advice. Confirm current ethics / national authority ethics, import, and coverage rules with qualified advisers and a licensed broker. We do not invent premiums, limits, or carrier rates on this page. We do not claim a named carrier as a signed bioaccess® partner here. No patient data. No unpublished client. Always bioaccess®.

If you searched named insured site vs sponsor clinical trial, additional insured PI ethics committee, certificate of insurance named insured FIH, you were looking for someone who would write international clinical-trial coverage for an investigational device. bioaccess® is a first-in-human medical-device CRO. We are not an insurance carrier. We do not underwrite policies. We do not sell premiums. We do not quote a binder. OUS and Latin American device trials still need trial-specific liability — local admitted paper, a master with local certificates, or both. We run the trial under ISO 14155. We can introduce a specialty carrier. That introduction is not a signed partnership on this page, and it is not a quote.

Ethics often wants the site and the PI on the certificate, not only the Delaware HoldCo. Sponsors hear “named insured” and add the wrong legal entity. This is not site-policy versus sponsor-policy (95980). That page is whose form. This page is whose name is on the form.

This page is not a clone of Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. That hub is the country-snapshot checklist (territory, named insureds, language, runoff). This page is the who must appear as named/additional insured intercept. Distinct slug. Distinct title. Same operator: the CRO runs the trial; a carrier writes the paper.

The CRO is not the carrier

Founders type “buy clinical trial insurance” and land on CROs, brokers, and hospital MSAs in the same result set. Those are three jobs:

• Carrier. Underwrites participant injury, medical expenses for trial-related events, defense, and site/investigator indemnification — if the form matches the protocol. A hallway conversation is not a binder.
• Broker. Places the form, translations, additional-insured endorsements, and territory wording. Licensed where the paper has to sit.
• CRO. Protocol, IB, ICF, ethics/ethics / national authority packet, importer of record for clinical trial devices in Latin America, ISO 14155 monitoring, SAE clock, TMF, and the 21 CFR 812.28 narrative. See OUS FIH and FDA IDE. Eligibility of foreign data is not FDA clearance.

Mixing those jobs is how a startup buys a U.S. product-liability rider, emails a PDF to an ethics committee, and gets a resubmission. Product liability is not clinical-trial liability. A site’s institutional policy is not the sponsor’s trial form.

Sponsor is the insured. Site is often additional insured

The sponsor buys the trial-liability form because the protocol is the sponsor’s. The committee still may require the institution and the investigator as additional insureds so a claim does not bounce between MSA indemnity and a policy that never named them. Endorsements take calendar time. Start them with protocol development, not the week of the CEC meeting.

Wrong entity, wrong country, wrong period

Naming a US parent when the CTA is with a subsidiary, naming a hospital system when the site is a foundation, or naming last year’s PI, are classic resubmissions. Spanish or Portuguese certificates must match the legal names in the ethics packet. We will not invent a naming statute. Confirm with the reviewing body and the broker. bioaccess® coordinates the packet. We do not issue endorsements.

What ethics and ethics / national authority actually ask for

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance. Use clinical-trials-peru. INS (DIIS, formerly OGITT) authorizes trials. A published statutory target on that hub is 40 business days in the drug-trial framework, and 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. We will not invent a new Peruvian clock on this page. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. The Peru hub already cites experience-based cost on the order of ~30% lower versus US/EU — that is a country-page figure, not a campus quote we invent here. We do not invent a Peruvian legal entity on this page.

Insurance documentation is usually in the ethics / ethics / national authority packet, not a post-approval formality. Typical asks (confirm with the reviewing body — we will not invent a pan-regional limit):

• Territory that names every country on the protocol.
• Site and principal investigator as additional insureds when the committee requires it.
• Policy period through last-patient last-visit plus the protocol follow-up window.
• Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
• Claims-notice language that can sit next to the SAE clock, not against it.

We will not invent a per-participant dollar figure on this page. Individual ethics committees set thresholds. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

A master that cannot add additional insureds in-country is the wrong master. A local policy that names only the site and not the sponsor is also the wrong object. Ask for a specimen showing both before you bind.

A “controlled master” that never issues a local certificate is a slide, not a submission. A local-only policy that cannot travel to a second Latin American country is a one-country trap. The operator chooses geography for the device; the paper has to follow the protocol, not the other way around.

What bioaccess® still owns after you have a quote

1. Regulatory-fit, not tourism. Leftover-site campuses are names on a certificate, not sellers of one. Do not email Favaloro or a Recife hospital to “be the insured” instead of buying sponsor paper.
2. Protocol, IB, ICF, and the ethics / ethics / national authority packet with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. Introducing a specialty carrier when the founder does not already have admitted paper. Introduction is not a signed partnership on this page. We do not invent rates.

The firm was founded in 2010. Public device case studies (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as already published) show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting. We will not invent a premium from those pages.

Colombia is still on the map

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

A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. That does not flip the public line. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs.

Frequently asked questions

Does bioaccess® sell clinical trial insurance?

No. We are the FIH CRO. We can introduce a carrier. We do not underwrite. We do not bind. We do not invent a rate card on this page.

Is this the same article as the LATAM insurance hub?

No. The hub is Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. This page is who must appear as named/additional insured. Do not treat them as clones.

Can a U.S. product-liability policy cover a LATAM device FIH?

Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.

Did bioaccess® underwrite the Avantec / Sangria™ $10M policy mentioned on public pages?

No. Public llms.txt copy says bioaccess® ran FIH execution that included placing a $10M clinical-trial insurance policy as an operational workstream. That is CRO coordination, not underwriting. It is not a SKU. It is not a rate we invent here.

Next step

If the search that brought you here was named insured site vs sponsor on the FIH certificate, start as the operator: contact bioaccess® or book from First-in-Human CRO. Siblings (do not clone): site vs sponsor policy, investigator vs sponsor.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not insurance, legal, or regulatory advice. Confirm current ethics / national authority ethics, import, and coverage rules with qualified advisers and a licensed broker. We do not invent premiums, limits, or carrier rates on this page. We do not claim a named carrier as a signed bioaccess® partner here. No patient data. No unpublished client. Always bioaccess®.

If you searched subject injury vs third party liability clinical trial, TPL vs participant injury FIH, CGL vs trial liability device, you were looking for someone who would write international clinical-trial coverage for an investigational device. bioaccess® is a first-in-human medical-device CRO. We are not an insurance carrier. We do not underwrite policies. We do not sell premiums. We do not quote a binder. OUS and Latin American device trials still need trial-specific liability — local admitted paper, a master with local certificates, or both. We run the trial under ISO 14155. We can introduce a specialty carrier. That introduction is not a signed partnership on this page, and it is not a quote.

Boards buy general liability because they already have it. Ethics asks who pays if the investigational device injures the participant. Those are different grants. Third-party liability is premises and operations. Subject injury is the protocol. Mixing them is how a CGL PDF lands in a CNBI folder and comes back.

This page is not a clone of Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. That hub is the country-snapshot checklist (territory, named insureds, language, runoff). This page is the participant injury versus TPL/CGL intercept. Distinct slug. Distinct title. Same operator: the CRO runs the trial; a carrier writes the paper.

The CRO is not the carrier

Founders type “buy clinical trial insurance” and land on CROs, brokers, and hospital MSAs in the same result set. Those are three jobs:

• Carrier. Underwrites participant injury, medical expenses for trial-related events, defense, and site/investigator indemnification — if the form matches the protocol. A hallway conversation is not a binder.
• Broker. Places the form, translations, additional-insured endorsements, and territory wording. Licensed where the paper has to sit.
• CRO. Protocol, IB, ICF, ethics/ethics / national authority packet, importer of record for clinical trial devices in Latin America, ISO 14155 monitoring, SAE clock, TMF, and the 21 CFR 812.28 narrative. See OUS FIH and FDA IDE. Eligibility of foreign data is not FDA clearance.

Mixing those jobs is how a startup buys a U.S. product-liability rider, emails a PDF to an ethics committee, and gets a resubmission. Product liability is not clinical-trial liability. A site’s institutional policy is not the sponsor’s trial form.

Third-party / CGL is the wrong exhibit

CGL and TPL can cover a visitor who slips in a corridor. They typically exclude professional services, clinical research, and investigational products. Territory may exclude Latin America. Additional insureds may not include the PI. Filing CGL as “our insurance” wastes the ethics cycle. We will not invent a TPL limit that substitutes for subject injury.

Subject injury is the grant ethics named

Batch 2 already has a LATAM subject-injury intercept (device-fih-subject-injury-coverage-latam). This page is the contrast: TPL versus that grant. Medical expenses for trial-related events, defense on a protocol claim, indemnification that matches the CTA — that is trial-liability. A warehouse policy is not. Public Avantec $10M copy is a trial-policy workstream, not a CGL SKU.

What ethics and ethics / national authority actually ask for

Use CRO in Colombia. Published comparison already on the Panama country page: Colombia ethics typically 4–6 weeks; per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email in Montería is not INVIMA clearance. Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

Insurance documentation is usually in the ethics / ethics / national authority packet, not a post-approval formality. Typical asks (confirm with the reviewing body — we will not invent a pan-regional limit):

• Territory that names every country on the protocol.
• Site and principal investigator as additional insureds when the committee requires it.
• Policy period through last-patient last-visit plus the protocol follow-up window.
• Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
• Claims-notice language that can sit next to the SAE clock, not against it.

We will not invent a per-participant dollar figure on this page. Individual ethics committees set thresholds. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

A master CGL with a worldwide footer is still CGL. Ask the carrier for the trial-liability form, then for a local certificate if ethics wants one. Do not rename TPL in a cover letter.

A “controlled master” that never issues a local certificate is a slide, not a submission. A local-only policy that cannot travel to a second Latin American country is a one-country trap. The operator chooses geography for the device; the paper has to follow the protocol, not the other way around.

What bioaccess® still owns after you have a quote

1. Regulatory-fit, not tourism. Colombia still wants financial responsibility for participant injury. That does not flip the public line. bioaccess® still runs trials in Colombia.
2. Protocol, IB, ICF, and the ethics / ethics / national authority packet with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. Introducing a specialty carrier when the founder does not already have admitted paper. Introduction is not a signed partnership on this page. We do not invent rates.

The firm was founded in 2010. Public device case studies (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as already published) show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting. We will not invent a premium from those pages.

Colombia is still on the map

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

A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. That does not flip the public line. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs.

Frequently asked questions

Does bioaccess® sell clinical trial insurance?

No. We are the FIH CRO. We can introduce a carrier. We do not underwrite. We do not bind. We do not invent a rate card on this page.

Is this the same article as the LATAM insurance hub?

No. The hub is Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. This page is participant injury versus TPL/CGL. Do not treat them as clones.

Can a U.S. product-liability policy cover a LATAM device FIH?

Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.

Did bioaccess® underwrite the Avantec / Sangria™ $10M policy mentioned on public pages?

No. Public llms.txt copy says bioaccess® ran FIH execution that included placing a $10M clinical-trial insurance policy as an operational workstream. That is CRO coordination, not underwriting. It is not a SKU. It is not a rate we invent here.

Next step

If the search that brought you here was subject injury vs third-party liability for FIH, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling: device FIH subject-injury coverage.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not insurance, legal, or regulatory advice. Confirm current ethics committee / IRB ethics, import, and coverage rules with qualified advisers and a licensed broker. We do not invent premiums, limits, or carrier rates on this page. We do not claim a named carrier as a signed bioaccess® partner here. No patient data. No unpublished client. Always bioaccess®.

If you searched EC IRB insurance certificate to start, ethics committee certificate of insurance clinical trial, IRB trial insurance LATAM, you were looking for someone who would write international clinical-trial coverage for an investigational device. bioaccess® is a first-in-human medical-device CRO. We are not an insurance carrier. We do not underwrite policies. We do not sell premiums. We do not quote a binder. OUS and Latin American device trials still need trial-specific liability — local admitted paper, a master with local certificates, or both. We run the trial under ISO 14155. We can introduce a specialty carrier. That introduction is not a signed partnership on this page, and it is not a quote.

Start-up is often blocked on one PDF: a certificate of insurance the ethics committee will file. Not a binder number on Slack. Not a broker email that says “in process.” A certificate: named insureds, territory, period, language. bioaccess® puts it in the packet. We do not issue it.

This page is not a clone of Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. That hub is the country-snapshot checklist (territory, named insureds, language, runoff). This page is the the ethics-committee certificate as a start-up gate intercept. Distinct slug. Distinct title. Same operator: the CRO runs the trial; a carrier writes the paper.

The CRO is not the carrier

Founders type “buy clinical trial insurance” and land on CROs, brokers, and hospital MSAs in the same result set. Those are three jobs:

• Carrier. Underwrites participant injury, medical expenses for trial-related events, defense, and site/investigator indemnification — if the form matches the protocol. A hallway conversation is not a binder.
• Broker. Places the form, translations, additional-insured endorsements, and territory wording. Licensed where the paper has to sit.
• CRO. Protocol, IB, ICF, ethics/ethics committee / IRB packet, importer of record for clinical trial devices in Latin America, ISO 14155 monitoring, SAE clock, TMF, and the 21 CFR 812.28 narrative. See OUS FIH and FDA IDE. Eligibility of foreign data is not FDA clearance.

Mixing those jobs is how a startup buys a U.S. product-liability rider, emails a PDF to an ethics committee, and gets a resubmission. Product liability is not clinical-trial liability. A site’s institutional policy is not the sponsor’s trial form.

What the clerk actually stamps

Committees in Panama (CNBI-registered), Chile (Law 20.120), Colombia, Brazil (CEP/CONEP), Mexico, Peru, Costa Rica, and El Salvador all vary. The common pattern from the live hub: insurance is a condition of approval, not a post-approval souvenir. Missing additional insureds, English-only certificates, and periods that die before follow-up are the usual resubmissions. We will not invent a pan-regional template.

Certificate versus binder versus MSA

A binder is the carrier’s temporary yes. A certificate is what ethics files. An MSA is the site contract. Start-up needs the certificate in the ethics PDF, not the MSA’s indemnity paragraph. Do not clone site-vs-sponsor (95980) or investigator-vs-sponsor (batch 2). This page is the start-up gate itself.

What ethics and ethics committee / IRB actually ask for

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance. Use clinical-trials-costa-rica. Costa Rica’s biomedical-research stack sits under Ley N.° 9234. An accredited CEC reviews the protocol first; then the study is registered with CONIS / the Ministry of Health. Combined ethics + regulatory clocks on the live country page are typically ~30–90 days. Confirm the current calendar with qualified advisers; an NCT location row is not CONIS registration. A statutory 3% CONIS canon on the study budget is published as a legal charge — not a CRO fee, and not a clinic markup we invent here. bioaccess® does not invent a Costa Rican legal entity on this page.

Insurance documentation is usually in the ethics / ethics committee / IRB packet, not a post-approval formality. Typical asks (confirm with the reviewing body — we will not invent a pan-regional limit):

• Territory that names every country on the protocol.
• Site and principal investigator as additional insureds when the committee requires it.
• Policy period through last-patient last-visit plus the protocol follow-up window.
• Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
• Claims-notice language that can sit next to the SAE clock, not against it.

We will not invent a per-participant dollar figure on this page. Individual ethics committees set thresholds. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

If the master cannot produce a certificate in time for the ethics calendar, you do not have paper. If local admitted paper is slower than the CEC date, say so before you book the meeting. bioaccess® sequences the packet. The carrier prints the exhibit.

A “controlled master” that never issues a local certificate is a slide, not a submission. A local-only policy that cannot travel to a second Latin American country is a one-country trap. The operator chooses geography for the device; the paper has to follow the protocol, not the other way around.

What bioaccess® still owns after you have a quote

1. Regulatory-fit, not tourism. Do not delay the certificate until after SIV. SIV is late. Ethics is early. bioaccess® still runs trials in Colombia — INVIMA-side ethics wants the same class of exhibit.
2. Protocol, IB, ICF, and the ethics / ethics committee / IRB packet with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. Introducing a specialty carrier when the founder does not already have admitted paper. Introduction is not a signed partnership on this page. We do not invent rates.

The firm was founded in 2010. Public device case studies (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as already published) show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting. We will not invent a premium from those pages.

Colombia is still on the map

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

A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. That does not flip the public line. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs.

Frequently asked questions

Does bioaccess® sell clinical trial insurance?

No. We are the FIH CRO. We can introduce a carrier. We do not underwrite. We do not bind. We do not invent a rate card on this page.

Is this the same article as the LATAM insurance hub?

No. The hub is Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. This page is the ethics-committee certificate as a start-up gate. Do not treat them as clones.

Can a U.S. product-liability policy cover a LATAM device FIH?

Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.

Did bioaccess® underwrite the Avantec / Sangria™ $10M policy mentioned on public pages?

No. Public llms.txt copy says bioaccess® ran FIH execution that included placing a $10M clinical-trial insurance policy as an operational workstream. That is CRO coordination, not underwriting. It is not a SKU. It is not a rate we invent here.

Next step

If the search that brought you here was EC/IRB insurance certificate to start, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling hub: Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. Operator: First-in-Human CRO.

Julio G. Martinez-Clark, CEO · bioaccess®