Author: Julio Martinez-Clark

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 No unpublished client.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 We do not quote a binder.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®

General information, not insurance, legal, or regulatory advice. Confirm current Uruguayan ethics / national file 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 Uruguay clinical trial coverage, buy trial insurance Uruguay device FIH, Uruguay trial liability, 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.

Uruguay is on the public bioaccess® countries list (llms.txt; live hub at clinical-trials-uruguay). That is enough to intercept the search. It is not enough to invent a Uruguayan statutory insurance tariff, a ministry acronym we have not footed, or a week-count we have not published. Confirm current ethics and coverage rules with qualified advisers. bioaccess® is not the carrier.

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 Uruguay insurance exhibit (public country page only) 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/Uruguayan ethics / national file 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.

Public geography is not a rate card

Cite clinical-trials-uruguay and the countries hub. We will not invent a new Uruguayan clock on this page. We will not pretend Uruguay is Argentina or Brazil. ANMAT and ANVISA intercepts are separate slugs (batch 2). If Uruguay is on the protocol, the liability exhibit still needs territory, period, named insureds, and a language the committee can file — the same operator logic as the hub, not a clone of CMS 95591.

Do not skip Colombia because someone Googled Uruguay

A Uruguay search is not a withdrawal from Colombia. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs. A Uruguayan certificate does not replace an INVIMA exhibit. A leftover-site hospital page is not this intercept.

What ethics and Uruguayan ethics / national file actually ask for

Use the live Uruguay country page. We will not invent unpublished ministry clocks, PAHO standing, or premiums here. Ask the reviewing ethics body and a licensed broker what certificate they will stamp.

Insurance documentation is usually in the ethics / Uruguayan ethics / national file 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 carrier’s master excludes Uruguay, say so before you freeze the country list. If local admitted paper is required, a manuscript certificate may fail. Get it in writing. Introduction is not a quote. No signed carrier partnership on this page.

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. Uruguay sits on the same public LATAM map as Panama, Chile, and Colombia. Insurance territory has to match the protocol, not a 115-country brochure.
2. Protocol, IB, ICF, and the ethics / Uruguayan ethics / national file 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 Uruguay insurance exhibit (public country page only). 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 Uruguay clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Uruguay operator: clinical-trials-uruguay. Sibling 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 CONIS / Ministry of Health 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 Costa Rica clinical trial coverage, CONIS trial insurance, Ley 9234 clinical trial liability, 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.

Costa Rica’s biomedical-research stack sits under Ley N.° 9234. An accredited CEC reviews first; then CONIS / the Ministry of Health registers the study. Combined ethics + regulatory clocks on the live country page are typically ~30–90 days. A 3% CONIS canon on the study budget is a legal charge, not a CRO fee, and not an insurance premium. We do not invent a Costa Rican legal entity. We do not underwrite.

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 Costa Rica CONIS / Ley 9234 insurance exhibit 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/CONIS / Ministry of Health 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.

The 3% canon is not trial liability

Founders mix the CONIS budget canon with “coverage.” They are different objects. The canon is a published legal charge on the study budget. Subject-injury paper is a carrier form. Paying the canon does not indemnify the participant. Filing a carrier certificate does not pay the canon. bioaccess® explains both. We sell neither.

CEC first, CONIS second, certificate in the stack

An NCT location row is not CONIS registration. A hallway conversation at a Costa Rican clinic is not that registration. ICIMED, CIMCA, and other Costa Rica leftover-site pages are campuses — not insurers. Named-insured and Spanish-language asks still belong to the carrier and the clerk. We will not invent a CONIS insurance minimum.

What ethics and CONIS / Ministry of Health actually ask for

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 / CONIS / Ministry of Health 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 excludes Costa Rica fails CONIS-side filing. A Costa Rica-only local policy that cannot add Colombia later is a trap if the protocol expands. bioaccess® still runs trials in Colombia.

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. We pick the country the device needs. Costa Rica is on the public countries hub. It is not a reason to skip INVIMA when Colombia is the indication.
2. Protocol, IB, ICF, and the ethics / CONIS / Ministry of Health 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 Costa Rica CONIS / Ley 9234 insurance exhibit. 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 Costa Rica clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Costa Rica operator: clinical-trials-costa-rica. Sibling 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 DNM / CNEIS 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 El Salvador clinical trial coverage, CNEIS trial insurance, buy FIH liability El Salvador, 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.

El Salvador is a public bioaccess® geography (DNM — Dirección Nacional de Medicamentos — on llms.txt; live hub at clinical-trials-el-salvador). Watershed and Avantec public case-study copy already name El Salvador as a study-conduct country. None of that makes bioaccess® a carrier. CNEIS-side ethics still wants paper.

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 El Salvador DNM/CNEIS insurance exhibit 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/DNM / CNEIS 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.

Use the live El Salvador hub. Do not invent a new clock

Cite clinical-trials-el-salvador and CRO in El Salvador. The insurance hub (CMS 95591) already noted SRS/CNEIS includes insurance review and that the policy period should align with study duration plus a post-study window. This page does not clone that hub. We will not invent a Salvadoran premium or a CNEIS minimum limit.

Public FIH copy is not a rate card

Avantec/Sangria™ public copy says bioaccess® ran FIH across El Salvador, Mexico, and Colombia including placing a $10M clinical-trial insurance policy as a workstream. That is coordination, not underwriting, not a SKU, not a number we resell here. Watershed public copy is regulatory/ethics approvals in El Salvador and Panama — still not a binder.

What ethics and DNM / CNEIS actually ask for

Use the live El Salvador country page rather than a pan-regional invention. Requirements are generally discussed next to Panama on the insurance hub; confirm with CNEIS and a licensed broker. We will not invent a new Salvadoran clock on this page.

Insurance documentation is usually in the ethics / DNM / CNEIS 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 excludes El Salvador fails the packet. A Salvadoran local policy that cannot later add Panama or Colombia is a protocol constraint. bioaccess® still runs trials in Colombia. We pick the country the device needs.

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. El Salvador is not a leftover-site hospital page. Do not mix Cediul or The Panama Clinic into this intercept.
2. Protocol, IB, ICF, and the ethics / DNM / CNEIS 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 El Salvador DNM/CNEIS insurance exhibit. 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 El Salvador clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. El Salvador operator: clinical-trials-el-salvador. Sibling 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 how startups buy trial liability before first site, bind clinical trial insurance before site selection 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.

Boards ask for insurance before they approve a country. Ethics asks for a named site on the certificate. Those two clocks fight. The move is not to skip paper. The move is a binder or a specimen with territory and a named-insured endorsement path, then a certificate once the site exists. bioaccess® sequences that. We do not sell the binder.

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 binding paper before site selection 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 wait for SIV to start the insurance workstream

The live hub already said: start insurance with protocol development, not after the protocol is frozen. This page is the startup version. You may not have a PI yet. You may still be choosing Panama versus Colombia. You still need a carrier who will write investigational-device trial liability in those countries. Specimen wording, territory, period, and additional-insured mechanics can be negotiated before the MSA. The named site goes on when the site is real.

Do not buy a site to unlock a policy

Picking a leftover NCT campus because “they have insurance” is the wrong object. See leftover-site kill pages — they are not carriers. Do not sign a hospital MSA to inherit institutional coverage. Do not let a broker delay the quote until after first-patient. Country first (the device’s country), specimen second, site third, certificate fourth, SIV fifth. We will not invent a week-count for a binder here.

What ethics and ethics / national authority actually ask for

Use live hubs to pick geography first: Panama, Colombia, Chile, Mexico, Brazil. Then ask the carrier whether they can certificate that country. bioaccess® still runs trials in Colombia.

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 startup can live on a master with certificates as countries and sites appear — if the carrier will actually issue them. A local-only policy in the wrong first country is wasted premium we will not estimate. Introduction is 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. Regulatory-fit, not tourism. One campus is not a reason to bind the wrong territory.
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 binding paper before site selection. 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 startups buy trial liability before the first site, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling who-writes: who writes FIH liability. Operator: First-in-Human CRO.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not insurance, legal, or regulatory advice. Confirm current ethics / national device 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 device FIH subject injury coverage LATAM, participant injury insurance investigational device, subject injury clinical trial Latin America, 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.

Subject injury is the sentence ethics actually cares about: who pays medical costs if the investigational device hurts the participant. That is not third-party premises liability. That is not the hospital’s malpractice. That is not product liability for a marketed widget. It is a trial form. bioaccess® does not write 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 subject-injury (participant) coverage for an investigational device 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 device 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.

What subject-injury language has to survive

A device FIH can include a procedure, an implant, a follow-up window, and explant or revision if the protocol requires it. The form has to follow the IB, not a drug-trial template. Medical expenses for trial-related events, sometimes beyond the participant’s social security or private health cover, are the usual ask. We will not invent a per-participant dollar or peso limit. Committees set thresholds. Confirm with the reviewing body and a licensed broker.

What subject-injury is not

It is not the site’s institutional policy. It is not the PI’s malpractice. It is not a U.S. GL policy with a silent OUS exclusion. It is not “we’re a Delaware C-corp so we self-insure” unless ethics accepted a financial guarantee in writing — and we will not invent that substitute here. Public Avantec/Sangria™ copy mentions a $10M clinical-trial insurance policy as a workstream bioaccess® coordinated. That is not a SKU. That is not underwriting.

What ethics and ethics / national device 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 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.

Insurance documentation is usually in the ethics / ethics / national device 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

Subject-injury can sit on a local admitted policy or on a master with a local certificate. The object has to name the country and the protocol period. A 115-country brochure does not treat a participant in Panama.

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. If the protocol adds Colombia, the exhibit has to name Colombia. bioaccess® still runs trials there. Do not flip the public line.
2. Protocol, IB, ICF, and the ethics / ethics / national device 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 subject-injury (participant) coverage for an investigational device. 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 device FIH subject-injury coverage in Latin America, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling: international device trial liability. 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 ISO trial policy vs local admitted, Crowe clinical trial insurance, ISO form clinical trial liability 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.

Founders search “ISO trial policy” and “Crowe” because a broker slide used those words. ISO here is an insurance-manuscript problem, not ISO 14155. Crowe is a name people type for international placement. Neither is a bioaccess® product. We do not name a signed broker or carrier partnership on this page. We run the trial. A licensed broker places paper. A carrier binds 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 manuscript/ISO-style international form versus local admitted exhibit 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.

ISO 14155 is the quality system. ISO-style paper is a different object

bioaccess® device protocols run under ISO 14155. That is monitoring, TMF, SAE, and the 21 CFR 812.28 narrative. It is not a liability form. An “ISO” trial policy in broker slang is usually a manuscript written on an international program. Local admitted paper is what some Latin American clerks will actually stamp. Do not mix the acronyms on a board slide.

Admitted vs manuscript is not master vs local

The local-vs-controlled-master intercept is CMS 95976. This page is the form language: a non-admitted or freedom-to-contract manuscript versus a locally admitted policy in the country of the ethics committee. Some countries will file a certificate from a manuscript. Some will not. Ask the clerk and the broker. We will not invent a country-by-country admitted-paper statute here. We will not invent Crowe or HDI rates.

What ethics and ethics / national authority actually ask for

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. 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.

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 committee wants admitted local paper, a London manuscript without a local certificate is a resubmission. If the committee will file a certificate from a master, do not buy a second local policy just because a slide said “admitted.” Get the requirement in writing. bioaccess® can introduce a specialty carrier or broker. Introduction is not a quote and not a partnership announcement.

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. Paper has to follow the protocol’s countries, including Colombia if Colombia is on the map. 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 manuscript/ISO-style international form versus local admitted exhibit. 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 ISO-style trial policy vs local admitted paper, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling (do not clone): local vs controlled master.

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 investigator vs sponsor policy OUS, PI malpractice clinical trial insurance, investigator indemnification 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.

Investigators have malpractice. Sponsors need trial-liability. Ethics wants the sponsor form, often with the PI named as additional insured. Filing the PI’s malpractice certificate as if it were the trial form is how you lose a calendar month. This is not the site-MSA intercept (CMS 95980). That page is hospital institutional coverage. This page is the investigator’s own policy.

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 investigator malpractice versus sponsor trial form 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.

What malpractice is built to do

Malpractice covers the clinician’s professional acts in ordinary care. It is not written for an investigational device that has never been in a human, a protocol-defined follow-up window, or a Delaware sponsor who imported the product. Some policies explicitly exclude research. Read the exclusion. Do not invent a workaround on a WhatsApp with the PI.

What the sponsor form has to add for the PI

Additional-insured status when the committee requires it. Indemnity in the clinical trial agreement that matches the policy. A claims-notice path that can sit next to the SAE clock. Territory that names the country. The CRO coordinates that stack. The carrier issues the endorsement. bioaccess® does not underwrite the PI and does not sell a PI rider.

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-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

Do not let a master “cover investigators” in a brochure replace the additional-insured endorsement the clerk asked for. Do not let the PI’s local malpractice replace the sponsor form. Both objects can exist. One does not eat the other.

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. Going direct to a PI to “use their insurance” is how you confirm interest and still fail ethics. Contract the CRO. Introduce a carrier for the sponsor form.
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 investigator malpractice versus sponsor trial form. 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 investigator vs sponsor policy for OUS FIH, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling (do not clone): site vs sponsor policy.

Julio G. Martinez-Clark, CEO · bioaccess®