Category: Navigating Regulatory Landscapes in Latin America

General information, not insurance, legal, or regulatory advice. Confirm current ANMAT 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 No unpublished client.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 Argentina ANMAT clinical trial liability, buy trial insurance Argentina device FIH, ANMAT trial coverage, 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 We do not quote a binder.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.

Argentina is a real device-trial geography. ANMAT trial authorization is a petition. Commercial registro is a different petition. Neither petition is a liability binder. bioaccess® files the operator stack. A carrier writes the 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 ANMAT / Argentine ethics 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/ANMAT 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 put trial authorization and registro on one insurance Gantt

A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs. That is a start-up clock, not a premium. We will not invent an ANMAT insurance tariff or a per-participant peso limit on this page. Ethics still wants financial responsibility for participant injury in the packet with the protocol and ICF. A Buenos Aires hospital MSA is not that exhibit. Leftover-site intercepts on this blog (Favaloro, Argerich, Finochietto, Independencia Munro) are campuses, not carriers.

Spanish certificate, named PI, named site

Argentine ethics will read Spanish. They will look for the sponsor, the investigator, and the site. They will look for a period that covers follow-up. A U.S. product-liability rider that excludes OUS research is a rejection waiting for a clerk. A master that cannot issue an Argentine certificate is a slide. Ask which object you are buying. bioaccess® can introduce a specialty carrier. We do not bind ANMAT risk. We do not name a signed partnership here.

What ethics and ANMAT actually ask for

Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.

Insurance documentation is usually in the ethics / ANMAT 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 local admitted Argentine policy can satisfy one committee and still fail if the protocol later adds Colombia or Panama. A master can sit behind certificates if the carrier will actually print them. Do not clone the local-vs-master intercept (CMS 95976); this page is Argentina-only.

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 Argentina is the wrong first country for this device, say so early. bioaccess® still runs trials in Colombia and the rest of the platform. Insurance territory has to match that map.
2. Protocol, IB, ICF, and the ethics / ANMAT 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 ANMAT / Argentine ethics 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 Argentina ANMAT trial liability, start as the operator: contact bioaccess® or book from First-in-Human CRO. Do not clone leftover-site campus pages. Sibling: who writes FIH liability.

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 115-country clinical trial coverage, 115 country trial insurance device startup, multinational 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.

Some specialty carriers market multinational clinical-trial liability with a large country count. Founders type that number because a slide or an ad used it. bioaccess® will not invent, confirm, or sell that number. We are not the carrier. If your protocol is one Latin American country this year, you do not need a poster of 115 flags. You need a certificate ethics will file.

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 multinational-territory search intercept 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 buy a country-count. Buy the exhibit for this protocol

A device FIH in Panama, Colombia, Chile, Mexico, or Brazil is a named-territory problem. A brochure that lists a three-digit country count is marketing. It is useful only if the carrier will actually issue a local certificate for the countries on your protocol, in the right language, with the PI and site named, through follow-up. If they will not, the number is decoration. We will not reprint a carrier’s country list here. We will not name a signed partnership. Exploratory introductions stay exploratory until Julio says otherwise.

What a startup actually needs in year one of FIH

One or two countries, ISO 14155, importer of record, an ethics packet, and paper that matches those countries. Plus a path to add a country without rebuilding the program. That path can be a master. It can be a second local policy. It is not a CRO pretending to be an insurer. It is not a hospital MSA. It is not a U.S. product-liability rider with “worldwide” in the footer and a silent OUS-research exclusion.

What ethics and ethics / national authority actually ask for

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

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

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

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

Local policy vs controlled master

If you already have a multinational master, bring the specimen certificate to the CRO before ethics. If you do not, we can introduce a specialty carrier. Introduction is not a quote. We do not invent rates. We do not bind 115 countries. We run the trial in the countries the device needs — including Colombia, where we still run trials.

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. Country-count marketing is not a regulatory strategy. bioaccess®’s map is the Latin American FIH platform and the 21 CFR 812.28 package. See OUS FIH and FDA IDE.
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 multinational-territory search intercept. 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 115-country trial coverage for a device startup, start as the operator: contact bioaccess® or book from First-in-Human CRO. If you still need the country-snapshot checklist, use the hub (do not clone it): 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 site insurance vs sponsor policy FIH, hospital MSA insurance clinical trial, does the site cover 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.

Sites have insurance. That sentence has wrecked more start-up calendars than a slow CEP. Institutional coverage is for the hospital’s operations. Sponsor trial-liability is for the investigational protocol. Ethics wants the second object. A CRO who lets you file the first object as if it were the second is not doing the job.

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 hospital MSA coverage 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 a site policy is built to do

A named hospital can carry malpractice, premises, and sometimes clinical-research riders for its employees. That is necessary for the MSA. It is not sufficient for a first-in-human device. The participant is in a sponsor protocol. The investigational product is the sponsor’s. Import, IB, and ISO 14155 monitoring are the sponsor’s stack. When a committee asks who pays if the device injures the participant, “the hospital is insured” is not an answer unless the hospital is actually the sponsor — and on a bioaccess® FIH it is not.

What the sponsor form has to add

Additional insureds (PI and site) when the committee requires it. Territory that names the country. Period through follow-up. Language the clerk can file. Indemnity in the MSA that matches the policy — not a hospital template that dumps every investigational risk onto a Delaware C-corp with no paper behind it. Leftover-site kill pages on this blog already say “clinical trial insurance is required; we will not invent a campus-only premium.” This page is the dedicated intercept for that sentence.

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

Do not let a site MSA “include insurance” replace a master or a local trial policy. Do not let a master ignore the site’s additional-insured ask. 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 campus to “use their insurance” is how you confirm a room and still fail ethics. Contract the CRO. Let the CRO activate the site if the site fits. 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 hospital MSA coverage 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 site insurance vs sponsor policy for FIH, start as the operator: contact bioaccess® or book from First-in-Human CRO. Do not clone leftover-site campus pages. For the operator path: First-in-Human CRO. 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 COFEPRIS 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 Mexico COFEPRIS clinical trial coverage, buy trial insurance Mexico device FIH, COFEPRIS liability policy, 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.

Mexico is a real FIH geography for devices. COFEPRIS review on the live hub is typically 4–8 weeks after ethics (ethics 4–6 weeks; 2.8-month median start-up). None of those clocks is a premium. Coverage still has to be in the ethics packet. bioaccess® is not the Mexican 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 COFEPRIS / Mexican ethics coverage 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/COFEPRIS 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 confuse registro sanitario with trial liability

The Mexico hub keeps trial clocks separate from registro sanitario (~30 working days on that hub). A commercial registro is not a clinical-trial form. A COFEPRIS trial authorization is not a 21 CFR 812.28 clearance. Buying “Mexico coverage” from a product-liability broker who has never seen an investigational IB is how you get a territory endorsement that still fails the committee. We will not invent a Mexican per-participant insurance minimum here.

Spanish certificate, named site, named PI

Mexican ethics will read Spanish. They will look for the site and the investigator. They will look for a period that covers follow-up. Guadalajara, Monterrey, Mexico City, Zapopan, and Veracruz campuses on our leftover-site series are sites — they are not insurers. Do not email a hospital asking them to “include insurance” and call it COFEPRIS-ready. The hospital’s institutional policy is not the sponsor’s trial form.

What ethics and COFEPRIS 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.

Insurance documentation is usually in the ethics / COFEPRIS 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 names “Mexico” in a 100-country schedule can still fail if it cannot issue a Spanish certificate for this protocol. A local Mexican policy can still fail if the protocol later adds Colombia. Ask which object you are buying. bioaccess® can introduce a specialty carrier. We do not bind COFEPRIS risk.

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. Mexico is not a substitute for Colombia or Panama. We pick the country the device needs. bioaccess® still runs trials in Colombia. A Mexican certificate does not replace an INVIMA exhibit.
2. Protocol, IB, ICF, and the ethics / COFEPRIS 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 COFEPRIS / Mexican ethics coverage 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 Mexico COFEPRIS clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Mexico operator pages: clinical-trials-mexico and CRO in Mexico. 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 ANVISA 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 Brazil ANVISA clinical trial liability, CONEP trial insurance, buy clinical trial coverage Brazil 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.

Brazil is a real device-trial geography. It is also a documentation geography. ANVISA, CEP, and CONEP do not accept “our U.S. broker said we’re covered.” They accept a file. bioaccess® prepares the file. A carrier writes the liability 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 ANVISA / CONEP / CEP 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/ANVISA 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.

ANVISA is the device dossier. Insurance is still in the ethics stack

Device investigations sit under RDC 837/2023 (Portuguese dossier: IB, protocol, ICF, insurance or equivalent financial guarantee, GMP evidence). CEP clocks on the live Brazil hub are capped at 30 business days; combined ethics + ANVISA is typically 6–10 weeks under Law 14874. Those are start-up clocks, not premiums. We will not invent a Brazilian insurance tariff or a CONEP minimum limit on this page. We will say the guarantee belongs in the packet on day one, not after CEP questions arrive.

Portuguese, period, and named insureds

A certificate that cannot be read in Portuguese is a delay. A period that dies before last-patient last-visit is a delay. A form that names only the Delaware HoldCo and not the site is a delay. Brazil is not always the first FIH country on a bioaccess® map — Panama and Chile are often faster — but when Brazil is on the protocol, the liability exhibit has to be Brazilian-grade. Do not copy a Panama CNBI certificate onto a CONEP upload and hope.

What ethics and ANVISA actually ask for

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

Insurance documentation is usually in the ethics / ANVISA 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

Some sponsors keep a master and issue a Brazilian certificate. Some buy local admitted paper. Either object has to survive CEP/CONEP. A master that excludes Brazil, or a local policy that cannot later add Colombia, is a protocol constraint — tell the CRO before you freeze the country list.

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 Brazil is the wrong first country for this device, say so early. bioaccess® still runs trials in Colombia and other Latin American countries. Insurance territory is not a reason to pretend Brazil is Panama.
2. Protocol, IB, ICF, and the ethics / ANVISA 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 ANVISA / CONEP / CEP 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 Brazil ANVISA clinical trial liability, start as the operator: contact bioaccess® or book from First-in-Human CRO. Brazil operator page: clinical-trials-brazil. 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 INVIMA 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 Colombia INVIMA clinical trial insurance, INVIMA trial liability coverage, buy trial insurance Colombia, 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.

Colombia is still on the bioaccess® map. That is not a slogan and it is not a reason to skip the insurance exhibit. INVIMA-side ethics still wants financial responsibility for participant injury. The CRO files the packet. A carrier writes the 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 INVIMA / Colombian ethics 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/INVIMA 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 this page is not

This page does not say bioaccess® left Colombia. That story is false. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country, Miami headquarters. FOSCAL, La Sabana, Cardioinfantil, and Fundación Neumológica Colombiana intercepts do not flip that line. This page also does not sell a Colombian policy. We do not underwrite INVIMA risk.

What the Colombian packet actually wants

INVIMA and institutional ethics (Resolución 8430/1993 still sits on the ethics/research side) review financial responsibility as part of start-up, not as a souvenir after first patient. Expect questions about territory (Colombia named), period (through follow-up), and who is insured (sponsor, PI, site). Resolución 2378 does not govern device clinical trials — do not import a drug-GCP resolution onto a device insurance exhibit. We will not invent a Colombian statutory premium or a per-patient insurance tariff here. Live country comparison on the Panama hub still cites Colombia ethics typically 4–6 weeks and per-patient $15,000–$25,000 as operational cost, not as an insurance limit.

What ethics and INVIMA 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.

Insurance documentation is usually in the ethics / INVIMA 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 U.S. master that excludes Colombia is a rejection waiting for a clerk. A Colombian local policy that cannot later add Panama or Brazil is a one-country trap if the protocol expands. Ask the carrier which object they will issue for INVIMA-side ethics, in Spanish, with the site named. bioaccess® can introduce that conversation. We do not bind it.

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. If that country is Colombia, the insurance exhibit is in the same stack as the INVIMA/ethics packet, the importer-of-record file, and ISO 14155 monitoring — not a founder WhatsApp to a Bogotá hospital.
2. Protocol, IB, ICF, and the ethics / INVIMA 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 INVIMA / Colombian ethics 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 Colombia INVIMA clinical trial insurance, start as the operator: contact bioaccess® or book from First-in-Human CRO. Colombia operator page (do not clone): CRO in Colombia. 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 OUS FIH local policy vs controlled master, local admitted clinical trial insurance vs master policy, 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 like “one global master.” Ethics committees like a certificate they can read. Both can be true. Neither is automatic. The failure mode is a master that never issues a local exhibit, or a local policy that cannot follow the protocol into a second country.

This page is not a clone of Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. That hub is the country-snapshot checklist (territory, named insureds, language, runoff). This page is the local admitted paper versus master certificate 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 “local” means in a LATAM device packet

Local, here, means the reviewing ethics committee and the national file can accept the document: language, named insureds, territory, period, and sometimes notarization. Panama CNBI, Chile ISP-adjacent ethics, INVIMA-side committees, CONEP, and COFEPRIS-side ethics do not share a template. A Miami PDF in English is a common resubmission. The CRO knows which packet the certificate sits in. The carrier issues the object. bioaccess® does not print the object.

What “controlled master” has to produce

A master is useful when the same sponsor will add countries, keep one underwriter, and issue certificates without rewriting the program. It is useless if the master excludes Latin America, excludes investigational devices, or cannot name a PI as additional insured. “Controlled” is a carrier word. Ask what certificate they will actually issue for the first country on the protocol, in the language the committee uses, with a period that covers follow-up. If the answer is a slide, you do not have paper.

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-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

Use both when the protocol needs both: a master for the board and the second country; a local certificate for the first ethics clerk. Do not pay twice for the same limit without asking. Do not skip the local certificate because the master “covers 100+ countries” in a brochure. We will not invent or certify a country count here.

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. Start in the country the device needs. Add Colombia or Brazil only if the indication and the paper can follow. bioaccess® still runs trials in Colombia — that is operator geography, not a reason to skip INVIMA-side financial-responsibility exhibits.
2. Protocol, IB, ICF, and the ethics / ethics / national authority packet with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. Introducing a specialty carrier when the founder does not already have admitted paper. Introduction is not a signed partnership on this page. We do not invent rates.

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

Colombia is still on the map

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

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

Frequently asked questions

Does bioaccess® sell clinical trial insurance?

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

Is this the same article as the LATAM insurance hub?

No. The hub is Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start. This page is local admitted paper versus master certificate. 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 local policy vs controlled master for OUS FIH, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country clocks live on the hubs, not on a carrier brochure. Start with Panama or Colombia.

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 international clinical trial liability medical device, investigational device trial insurance OUS, 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.

Drug-trial GL language is not a device FIH form. An investigational implant, catheter, or diagnostic that has never been in a human is a different risk sentence than a marketed pill. Carriers who write “clinical trials” still have to read the IB.

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 device-specific trial liability (not drug GL) 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.

Device FIH is not a protocol footnote on a drug policy

A first-in-human medical device study asks a participant to accept an investigational product that may stay in the body, may require a procedure, and may generate SAE clocks the FDA will later read under 21 CFR 812.28. The liability form has to follow that protocol: procedure-related injury, device malfunction language, explant or revision costs if the protocol requires them, and follow-up windows that are often longer than a three-visit drug trial. We will not invent a device-class tariff here. The carrier reads the IB. The CRO writes the IB.

OUS is a territory problem, not a slogan

“International” on a U.S. certificate often means “we have a London switchboard.” Ethics in Panama, Chile, Colombia, Brazil, or Mexico wants the country named. If the protocol later adds a second Latin American country, the endorsement has to move with it. bioaccess® picks geography for the device. The paper follows the protocol. A device startup that buys a U.S.-territory clinical-trial endorsement and then opens a Colombian site has bought the wrong object.

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 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 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

For a device FIH, local admitted paper is often what the ethics clerk files. A controlled master can sit behind it if the carrier will issue certificates in the right language with the PI and site named. Do not assume a master written for a 40-site drug program will print a one-site Panama device certificate next week. Ask. Get it in writing.

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 indication later needs Colombia, Brazil, or Mexico, the operator already runs those files. The carrier has to name them. bioaccess® still runs clinical trials in Colombia.
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 device-specific trial liability (not drug GL). 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 international clinical trial liability medical device, start as the operator: contact bioaccess® or book from First-in-Human CRO. Device-import sibling (do not clone): importer of record for clinical trial devices in Latin America.

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 buy international clinical trial coverage, who writes FIH clinical trial liability Latin America, HDI clinical trial insurance, 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.

Specialty carriers market multinational trial liability. Brokers place it. Hospitals photocopy a certificate. bioaccess® still has to put a device through ethics, import, and ISO 14155. Buying coverage is not starting the study.

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 writes the paper 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.

Why “buy coverage” searches land on a CRO

Google and LinkedIn do not separate “carrier,” “broker,” and “CRO.” A founder who has just been told “you need insurance before first patient” searches the phrase the board used. International. Clinical trial. Coverage. Liability. The ads and the blogs that answer are mixed. This page exists so that search does not treat bioaccess® as a binder. We introduce paper when the protocol needs it. We run the trial either way.

What you are actually buying

You are buying a form that ethics will file and that a later FDA reviewer can live with in the 21 CFR 812.28 package. You are not buying a CRO day-rate. You are not buying a hospital MSA. You are not buying a U.S. product-liability endorsement that silently excludes Panama, Colombia, Brazil, or Mexico. If a carrier’s marketing mentions a large country count, treat it as their marketing — not as a bioaccess® partnership and not as a number we will invent or certify here.

What ethics and ethics / national authority actually ask for

Use the live country hubs rather than a pan-regional invention: Panama MINSA/CNBI on clinical-trials-panama; Chile ISP on clinical-trials-chile; Brazil ANVISA/CEP on clinical-trials-brazil; Mexico COFEPRIS on clinical-trials-mexico; Colombia INVIMA on CRO in Colombia. Ethics typically wants the certificate in the same packet as the protocol and ICF.

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 local admitted policy can satisfy one ethics committee and still fail a second country. A master policy written in London, Munich, or New York can satisfy a board slide and still fail a CNBI or CONEP clerk who wants a local certificate in Spanish or Portuguese. Ask which of those two objects you are buying. Then ask who files it.

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. bioaccess® still runs trials in Colombia and the rest of the Latin American platform. Insurance territory has to match that map, not a U.S.-only endorsement.
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 writes the paper. 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 buy international clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling hub (do not clone): Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Clinica Privada Independencia first-in-human, Independencia Munro clinical trial, Independencia CRO, or “go direct Clínica Privada Independencia Munro,” you followed a campus string ClinicalTrials.gov still publishes. Clinica Privada Independencia in Munro, Argentina, is a real named private-clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This page is the named Munro Clínica Privada Independencia campus. It is not Sanatorio Finochietto (this batch), not Hospital Militar Cosme Argerich (CMS 95954), not Fundación Favaloro (CMS 95936), and not Hospital Universitario Austral Pilar (CMS 95926). Munro is Greater Buenos Aires, not CABA. Sharing a metro is not a license to collapse them.

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

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

Counts come from leftover unique strings after batch 40 (CMS 95958–95965 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Clinica Privada Independencia (Munro, Argentina) — canonical NCT string: ALL interventional n=6; DEVICE n=1. Example NCT IDs: NCT05084911, NCT07472517, NCT06097260. DEVICE example: NCT07544654.

Cite canonical ALL n=6 and DEVICE n=1. Do not clone Finochietto onto this slug.

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

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

That is the leak: a founder searching “Independencia Munro first-in-human” finds ALL n=6 (DEVICE n=1) without finding ANMAT. A named clinic is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation in Munro is not a Finochietto file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANMAT actually works (the short version)

Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.

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

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

Do not smear the hospital

Clínica Privada Independencia is a serious named Munro clinic on the public registry. ALL n=6 is registry volume, not a punchline. Do not invent a DEVICE n beyond 1. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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™.

Frequently asked questions

Can I contract Clínica Privada Independencia Munro directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Finochietto or Austral Pilar?

No. Sanatorio Finochietto is this batch. Hospital Universitario Austral Pilar is CMS 95926. This page is Independencia Munro only.

Did bioaccess® run NCT05084911?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Buenos Aires sibling (do not merge): Austral Pilar.

Julio G. Martinez-Clark, CEO · bioaccess®