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 No unpublished client.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 We do not quote a binder.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
- 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.
- Protocol, IB, ICF, and the ethics / ethics / national authority packet with insurance documents in the same stack — not a parallel founder email.
- Importer of record and device accountability. A binder does not import the investigational product.
- Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
- 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®