Category: Preparing for First-In-Human Studies

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 No unpublished client.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 Australia-only NCT medical device, second country Latin America FIH, CTN only device trial add LATAM, 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.

Some device protocols sit on ClinicalTrials.gov with Australia as the only country. That row is country 1. It is not a reason the next n has to wait on another CTN. Country 2 is Latin America: Panama, Chile, Brazil, Mexico, or El Salvador as the device needs. This page is not an Avania, Novotech, or GreenLight Clinical duplicate. Those operators have separate pages. This page is the geography pattern.

This page is not a hospital site page and not an insurance page. distinct page. 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

An Australia-only NCT location list is a snapshot, not a regulatory strategy. TGA/CTN does not import into MINSA, ISP, ANVISA, or COFEPRIS territory. A second Australian private hospital is not country 2. We will not scrape a new named sponsor list onto this page from CT.gov. We will not invent enrollment counts from a LATAM-only registry pull. If your protocol is already Australia-only, the operator question is whether the next amendment or the next protocol should add Latin America.

Do not use Australian campuses as the pitch

Site pages are a different topic. Do not email an Australian NCT facility and ask them to become a Latin American site. Do not treat R&DTI as a substitute for ISO 14155 monitoring in Panama. Nanochon stays HOLD.

Historic Alessa is not this page

NCT04284761 (Alessa Biolen-PC) listed Australia + New Zealand and later a US site; it is completed. Mentioned only as historic next-protocol context on the Avania AU page. It is not an Australia-only live steal and not a mail we send from here.

Country 2 is LATAM. It is not a second Australian CTN

Add country 2 before the protocol is frozen if the FDA-bridge story needs more n, more anatomy, or a backup geography when ANZ slots fill. Use the live clocks below. Colombia is an option too: bioaccess® runs first-in-human studies in Colombia now.

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

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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 in El Salvador). We will not invent a new Salvadoran clock here.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

A Bogotá hospital NCT row is facility evidence, not a CRO. If Colombia is country 2, bioaccess® runs first-in-human studies in Colombia now.

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. Published first-in-human device case studies 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 topics have their own pages. We do not underwrite. We do not name HDI as a partner here.

Can Colombia be country 2?

Yes. bioaccess® runs first-in-human studies in Colombia now. INVIMA registro is a separate service. See the Colombia paragraph above.

Next step

If the search that brought you here was Australia-only device NCT → LATAM as country 2, start as the operator: contact bioaccess® or book from First-in-Human CRO. Operator CROs in this cluster: Avania, Novotech, GreenLight Clinical.

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 JSS Medical Research Canada FIH CRO, JSS Montréal medical device trial, JSS LATAM device 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.

JSS Medical Research (Montréal HQ; Bogotá office via the 2013 LatAm Clinical Trials buy) sells Phase I–IV including medical devices and LATAM ops. That LATAM language is why device founders type the name. It is still not a public named FIH protocol. A capability sentence is not ISO 14155 hospital implant evidence. We will not pad this page with an invented valve, embolic, or robot study just to look even with Avania’s Remedy N1 keeper. Locked 28 Aug and 1 Sep 2026: no case-study / success-story pages and no named device protocol found. Empty device cases stay empty. We will not invent a named device study to fill this page.

This page is not a hospital site page and not an insurance page. distinct page. 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

The search is still real. Canadian device founders type JSS because the shop already speaks LATAM. A Bogotá office is not a reason to book a new INVIMA FIH from this cluster. Country 2 for new FIH execution is Panama, Chile, Brazil, Mexico, or El Salvador. Colombia stays INVIMA registro / market access.

What the public site does not give us

Service copy is not a protocol. Logo walls without a device FIH/EFS case are not stealable rows. We will not borrow Avania’s Remedy N1 onto JSS. We will not borrow Pi-Cardia onto JSS. We will not add extra CRO brands.

Watch, do not fabricate

If JSS later publishes a named device FIH/EFS, that is a monthly refresh. Until then this page answers the query and sends the founder to an operator who actually runs hospital implant FIH in Latin America. Do not treat a Montréal MSA as ISO 14155 in Panama.

Country 2 is LATAM. It is not a second Australian CTN

Canada-only NCT geography shares a page with Israel-only — not a ninth page. JSS-the-brand is this page.

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

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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 in El Salvador). We will not invent a new Salvadoran clock here.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

A Bogotá hospital NCT row is facility evidence, not a CRO. If Colombia is country 2, bioaccess® runs first-in-human studies in Colombia now.

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. Published first-in-human device case studies 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 topics have their own pages. We do not underwrite. We do not name HDI as a partner here.

Can Colombia be country 2?

Yes. bioaccess® runs first-in-human studies in Colombia now. INVIMA registro is a separate service. See the Colombia paragraph above.

Next step

If the search that brought you here was JSS Medical Research Canada as the FIH CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Siblings: Avania Canada, Israel- or Canada-only NCT.

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 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 hospital site page and not an insurance page. distinct page. 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 page 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

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 can also be Colombia, where bioaccess® runs first-in-human studies now.

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

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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 in El Salvador). We will not invent a new Salvadoran clock here.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

A Bogotá hospital NCT row is facility evidence, not a CRO. If Colombia is country 2, bioaccess® runs first-in-human studies in Colombia now.

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. Published first-in-human device case studies 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 topics have their own pages. We do not underwrite. We do not name HDI as a partner here.

Can Colombia be country 2?

Yes. bioaccess® runs first-in-human studies in Colombia now. INVIMA registro is a separate service. 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 hospital site page and not an insurance page. distinct page. 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 page 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.

Avania, Novotech, and GreenLight Clinical are separate

Avania publishes unnamed AU device FIH cases. Novotech publishes drug FIH cases. GreenLight Clinical publishes capability plus a named drug client. Three pages. Three jobs.

Country 2 is LATAM. It is not a second Australian CTN

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

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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 in El Salvador). We will not invent a new Salvadoran clock here.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

A Bogotá hospital NCT row is facility evidence, not a CRO. If Colombia is country 2, bioaccess® runs first-in-human studies in Colombia now.

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. Published first-in-human device case studies 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 topics have their own pages. We do not underwrite. We do not name HDI as a partner here.

Can Colombia be country 2?

Yes. bioaccess® runs first-in-human studies in Colombia now. INVIMA registro is a separate service. 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 hospital site page and not an insurance page. distinct page. 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 page.

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 page. Avania is the AU shop actually publishing device FIH cases. The three brands are separate.

Country 2 is LATAM. It is not a second Australian CTN

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. Colombia is an option too: bioaccess® runs first-in-human studies in Colombia now.

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

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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 in El Salvador). We will not invent a new Salvadoran clock here.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

A Bogotá hospital NCT row is facility evidence, not a CRO. If Colombia is country 2, bioaccess® runs first-in-human studies in Colombia now.

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. Published first-in-human device case studies 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 topics have their own pages. We do not underwrite. We do not name HDI as a partner here.

Can Colombia be country 2?

Yes. bioaccess® runs first-in-human studies in Colombia now. INVIMA registro is a separate service. 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 hospital site page and not an insurance page. distinct page. 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

Canada-only NCT rows are the sibling page. This page is the Avania-Canada operator.

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

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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 in El Salvador). We will not invent a new Salvadoran clock here.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

A Bogotá hospital NCT row is facility evidence, not a CRO. If Colombia is country 2, bioaccess® runs first-in-human studies in Colombia now.

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. Published first-in-human device case studies 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 topics have their own pages. We do not underwrite. We do not name HDI as a partner here.

Can Colombia be country 2?

Yes. bioaccess® runs first-in-human studies in Colombia now. INVIMA registro is a separate service. 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 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 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 hospital site page and not an insurance page. distinct page. 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. We 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 page). 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

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 timed to each committee’s meeting schedule and COFEPRIS timing study-specific, set by the protocol and each regulator’s review. No AU entity. No R&DTI wait. Do not book a second CTN just because Avania is already in Melbourne.

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

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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 in El Salvador). We will not invent a new Salvadoran clock here.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

A Bogotá hospital NCT row is facility evidence, not a CRO. If Colombia is country 2, bioaccess® runs first-in-human studies in Colombia now.

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. Published first-in-human device case studies 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 topics have their own pages. We do not underwrite. We do not name HDI as a partner here.

Can Colombia be country 2?

Yes. bioaccess® runs first-in-human studies in Colombia now. INVIMA registro is a separate service. 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. Related page: Avania Canada. Country-2 NCT page: Australia-only NCT → LATAM.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not insurance, legal, or regulatory advice. Confirm current ethics-committee, regulatory, import and coverage rules with qualified advisers and a licensed broker. This page does not quote premiums, limits or carrier rates.

What the law says (verified 29 October 2026)

Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country sets out each country’s rule with links to the primary text. Recent rule changes and the primary-law rules that matter most for this topic:

• Mexico: under the COFEPRIS simplification Acuerdo of 24 April 2025 (DOF 28 April 2025), art. 5, the study insurance (policy or certificate) or a current financial fund is no longer part of the initial COFEPRIS application. It must be filed within 15 business days after the protocol is authorized, or the authorization can be revoked. This changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve. No-risk observational studies are exempt. NOM-012-SSA3-2012 §5.14 still requires the fund for compensation. See Mexico’s 15-business-day rule.
• Argentina: ANMAT Disposición 7516/2025 (in force 1 December 2025, replacing Disp. 6677/2010), Annex II §3.14, says a study may start only once the sponsor has contracted a “seguro constituido en el país” (insurance taken out in Argentina). The consent form must name the insurer and its address. This applies to clinical pharmacology studies of medicines. ANMAT’s device rule (Disp. 969/1997) has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there (Ley 3301, art. 12), and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved (Decreto 3389/2024, art. 8).
• Panama: Decreto Ejecutivo 21 of 23 April 2026, art. 67(2), requires the investigator to obtain from the sponsor “financial provisions” for compensating possible damage and to attach that agreement to the bioethics submission. We did not find an explicit insurance-policy mandate in the decree; a certificate of insurance is the usual way to document the provision, and committees may ask for one.
• Brazil: Lei 14.874/2024 (arts. 23 and 26 XV) makes the sponsor responsible for indemnifying participants and for their trial-related care. The statute itself does not require an insurance policy, and its regulating Decreto 12.651/2025 adds none that we found. CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). Under Lei Complementar 126/2007, art. 19, insurance bought by Brazil-resident people or Brazil-domiciled companies for risks in Brazil must be placed in Brazil, with narrow exceptions in art. 20.
• Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.
• Costa Rica: Ley 9234 art. 31 and Decreto 39061-S art. 14 require a civil liability policy enforceable in Costa Rica, from an insurer with a branch or service center in the country. Under the decree it runs at least two years after the final report is delivered to the ethics committee (art. 14(a)) and three years after each participant’s participation ends (art. 14(b)); Ley 9234 art. 31 sets a floor of two years after participation ends. Each participant receives proof of the policy (art. 32). See Costa Rica under Ley 9234.

None of these rules sets a minimum dollar limit. Limits come from contracts and underwriting. Insurers price a specific protocol, so see what insurers need before they’ll quote.

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. The earlier “before first site” page covers country-and-specimen sequencing. This page is the SIV clock: bind and certificate before anyone flies to the site.

This page is separate from Clinical Trial Liability Insurance in Latin America: Requirements by Country. That hub sets out each country’s legal requirement with primary-law citations. This page’s topic: binder-before-SIV sequencing for a US device startup. 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-committee and national authority submission, 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. A hospital corridor is not a binder.

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.

What ethics committees and the national authority actually ask for

Use Clinical Trials in 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 in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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-committee and national authority submission, not a post-approval formality. Two exceptions: in Mexico the policy goes to COFEPRIS within 15 business days after authorization, and in Brazil CEP/CONEP don’t ask for proof of insurance. Typical asks (confirm with the reviewing body):

• 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.

None of the national rules or ethics-committee documents we read sets a per-participant dollar minimum. 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-committee and national authority submission 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. An introduction is not a partnership or a quote.

The firm was founded in 2010. Published first-in-human device case studies show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting.

Colombia is still on the map

A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® runs first-in-human studies in Colombia now. bioaccess® has a local entity and office in Colombia, with headquarters in Miami. Ethics timing in Panama and Colombia follows each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. 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.

Is this the same article as the LATAM insurance hub?

No. The hub is Clinical Trial Liability Insurance in Latin America: Requirements by Country. This page is binder-before-SIV sequencing for a US device startup.

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.

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-committee, regulatory, import and coverage rules with qualified advisers and a licensed broker. This page does not quote premiums, limits or carrier rates.

What the law says (verified 29 October 2026)

Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country sets out each country’s rule with links to the primary text. Recent rule changes and the primary-law rules that matter most for this topic:

• Mexico: under the COFEPRIS simplification Acuerdo of 24 April 2025 (DOF 28 April 2025), art. 5, the study insurance (policy or certificate) or a current financial fund is no longer part of the initial COFEPRIS application. It must be filed within 15 business days after the protocol is authorized, or the authorization can be revoked. This changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve. No-risk observational studies are exempt. NOM-012-SSA3-2012 §5.14 still requires the fund for compensation. See Mexico’s 15-business-day rule.
• Argentina: ANMAT Disposición 7516/2025 (in force 1 December 2025, replacing Disp. 6677/2010), Annex II §3.14, says a study may start only once the sponsor has contracted a “seguro constituido en el país” (insurance taken out in Argentina). The consent form must name the insurer and its address. This applies to clinical pharmacology studies of medicines. ANMAT’s device rule (Disp. 969/1997) has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there (Ley 3301, art. 12), and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved (Decreto 3389/2024, art. 8).
• Panama: Decreto Ejecutivo 21 of 23 April 2026, art. 67(2), requires the investigator to obtain from the sponsor “financial provisions” for compensating possible damage and to attach that agreement to the bioethics submission. We did not find an explicit insurance-policy mandate in the decree; a certificate of insurance is the usual way to document the provision, and committees may ask for one.
• Brazil: Lei 14.874/2024 (arts. 23 and 26 XV) makes the sponsor responsible for indemnifying participants and for their trial-related care. The statute itself does not require an insurance policy, and its regulating Decreto 12.651/2025 adds none that we found. CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). Under Lei Complementar 126/2007, art. 19, insurance bought by Brazil-resident people or Brazil-domiciled companies for risks in Brazil must be placed in Brazil, with narrow exceptions in art. 20.
• Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.
• Costa Rica: Ley 9234 art. 31 and Decreto 39061-S art. 14 require a civil liability policy enforceable in Costa Rica, from an insurer with a branch or service center in the country. Under the decree it runs at least two years after the final report is delivered to the ethics committee (art. 14(a)) and three years after each participant’s participation ends (art. 14(b)); Ley 9234 art. 31 sets a floor of two years after participation ends. Each participant receives proof of the policy (art. 32). See Costa Rica under Ley 9234.

None of these rules sets a minimum dollar limit. Limits come from contracts and underwriting. Insurers price a specific protocol, so see what insurers need before they’ll quote.

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 (separate page). That page is whose form. This page is whose name is on the form.

This page is separate from Clinical Trial Liability Insurance in Latin America: Requirements by Country. That hub sets out each country’s legal requirement with primary-law citations. This page’s topic: who must appear as named/additional insured. 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-committee and national authority submission, 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, for a Brazilian site that asks for one, Portuguese) certificates must match the legal names in the ethics packet. Confirm with the reviewing body and the broker. bioaccess® coordinates the packet. We do not issue endorsements.

What ethics committees and the national authority actually ask for

Use Clinical Trials in 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 in Peru. INS (under DS 021-2017-SA) 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. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. The Peru country page cites experience-based costs about ~30% lower than in the US.

Insurance documentation is usually in the ethics-committee and national authority submission, not a post-approval formality. Two exceptions: in Mexico the policy goes to COFEPRIS within 15 business days after authorization, and in Brazil CEP/CONEP don’t ask for proof of insurance. Typical asks (confirm with the reviewing body):

• 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.

None of the national rules or ethics-committee documents we read sets a per-participant dollar minimum. 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. Site-page 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-committee and national authority submission 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. An introduction is not a partnership or a quote.

The firm was founded in 2010. Published first-in-human device case studies show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting.

Colombia is still on the map

A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® runs first-in-human studies in Colombia now. bioaccess® has a local entity and office in Colombia, with headquarters in Miami. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. 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.

Is this the same article as the LATAM insurance hub?

No. The hub is Clinical Trial Liability Insurance in Latin America: Requirements by Country. This page is who must appear as named/additional insured.

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.

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. Related pages: site vs sponsor policy, investigator vs sponsor.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not insurance, legal, or regulatory advice. Confirm current ethics-committee, regulatory, import and coverage rules with qualified advisers and a licensed broker. This page does not quote premiums, limits or carrier rates.

What the law says (verified 29 October 2026)

Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country sets out each country’s rule with links to the primary text. Recent rule changes and the primary-law rules that matter most for this topic:

• Mexico: under the COFEPRIS simplification Acuerdo of 24 April 2025 (DOF 28 April 2025), art. 5, the study insurance (policy or certificate) or a current financial fund is no longer part of the initial COFEPRIS application. It must be filed within 15 business days after the protocol is authorized, or the authorization can be revoked. This changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve. No-risk observational studies are exempt. NOM-012-SSA3-2012 §5.14 still requires the fund for compensation. See Mexico’s 15-business-day rule.
• Argentina: ANMAT Disposición 7516/2025 (in force 1 December 2025, replacing Disp. 6677/2010), Annex II §3.14, says a study may start only once the sponsor has contracted a “seguro constituido en el país” (insurance taken out in Argentina). The consent form must name the insurer and its address. This applies to clinical pharmacology studies of medicines. ANMAT’s device rule (Disp. 969/1997) has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there (Ley 3301, art. 12), and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved (Decreto 3389/2024, art. 8).
• Panama: Decreto Ejecutivo 21 of 23 April 2026, art. 67(2), requires the investigator to obtain from the sponsor “financial provisions” for compensating possible damage and to attach that agreement to the bioethics submission. We did not find an explicit insurance-policy mandate in the decree; a certificate of insurance is the usual way to document the provision, and committees may ask for one.
• Brazil: Lei 14.874/2024 (arts. 23 and 26 XV) makes the sponsor responsible for indemnifying participants and for their trial-related care. The statute itself does not require an insurance policy, and its regulating Decreto 12.651/2025 adds none that we found. CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). Under Lei Complementar 126/2007, art. 19, insurance bought by Brazil-resident people or Brazil-domiciled companies for risks in Brazil must be placed in Brazil, with narrow exceptions in art. 20.
• Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.
• Costa Rica: Ley 9234 art. 31 and Decreto 39061-S art. 14 require a civil liability policy enforceable in Costa Rica, from an insurer with a branch or service center in the country. Under the decree it runs at least two years after the final report is delivered to the ethics committee (art. 14(a)) and three years after each participant’s participation ends (art. 14(b)); Ley 9234 art. 31 sets a floor of two years after participation ends. Each participant receives proof of the policy (art. 32). See Costa Rica under Ley 9234.

None of these rules sets a minimum dollar limit. Limits come from contracts and underwriting. Insurers price a specific protocol, so see what insurers need before they’ll quote.

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 separate from Clinical Trial Liability Insurance in Latin America: Requirements by Country. That hub sets out each country’s legal requirement with primary-law citations. This page’s topic: participant injury versus TPL/CGL. 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-committee and national authority submission, 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.

Subject injury is the grant ethics named

A separate page already covers LATAM subject injury (Device FIH Subject-Injury Coverage in Latin America). 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.

What ethics committees and the national authority actually ask for

Use CRO in Colombia. Colombia ethics timing depends on each committee’s meeting schedule. Published comparison already on the Panama country page: per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email is not INVIMA clearance. Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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-committee and national authority submission, not a post-approval formality. Two exceptions: in Mexico the policy goes to COFEPRIS within 15 business days after authorization, and in Brazil CEP/CONEP don’t ask for proof of insurance. Typical asks (confirm with the reviewing body):

• 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.

None of the national rules or ethics-committee documents we read sets a per-participant dollar minimum. 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. bioaccess® still runs trials in Colombia.
2. Protocol, IB, ICF, and the ethics-committee and national authority submission 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. An introduction is not a partnership or a quote.

The firm was founded in 2010. Published first-in-human device case studies show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting.

Colombia is still on the map

A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® runs first-in-human studies in Colombia now. bioaccess® has a local entity and office in Colombia, with headquarters in Miami. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. 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.

Is this the same article as the LATAM insurance hub?

No. The hub is Clinical Trial Liability Insurance in Latin America: Requirements by Country. This page is participant injury versus TPL/CGL.

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.

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®