General information, not insurance, legal, or regulatory advice. Confirm current ethics-committee, regulatory, import and coverage rules with qualified advisers and a licensed broker. This page does not quote premiums, limits or carrier rates.
What the law says (verified 29 October 2026)
Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country sets out each country’s rule with links to the primary text. The rule for this country, from the primary text:
- Colombia: Resolución 2378 de 2008 (GCP for research with medicines) lists the participant insurance policy among the documents the ethics committee reviews, and its sponsor checklist asks for contractual and extra-contractual cover sized “according to international standards”. For device studies, INVIMA’s inspection tool checks for a policy under Res. 8430/1993, art. 13. No trial rule requires a Colombian insurer, but foreign insurers may not sell cover in Colombia (EOSF art. 39).
None of these rules sets a minimum dollar limit. Limits come from contracts and underwriting. Insurers price a specific protocol, so see what insurers need before they’ll quote.
If you searched 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 We do not quote a binder.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 separate from Clinical Trial Liability Insurance in Latin America: Requirements by Country. That hub sets out each country’s legal requirement with primary-law citations. This page’s topic: INVIMA / Colombian ethics insurance exhibit. 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 pages 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. Colombia ethics timing depends on each committee’s meeting schedule, and the live country comparison on the Panama hub still cites 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. Colombia ethics timing depends on each committee’s meeting schedule. Published comparison already on the Panama country page: per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email is not INVIMA clearance.
Insurance documentation is usually in the ethics / INVIMA packet, not a post-approval formality. Two exceptions: in Mexico the policy goes to COFEPRIS within 15 business days after authorization, and in Brazil CEP/CONEP don’t ask for proof of insurance. Typical asks (confirm with the reviewing body):
- Territory that names every country on the protocol.
- Site and principal investigator as additional insureds when the committee requires it.
- Policy period through last-patient last-visit plus the protocol follow-up window.
- Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
- Claims-notice language that can sit next to the SAE clock, not against it.
None of the national rules or ethics-committee documents we read sets a per-participant dollar minimum. Ask the carrier and the CRO together, before the packet goes in.
Local policy vs controlled master
A 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
- 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.
- Protocol, IB, ICF, and the ethics / INVIMA 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. An introduction is not a partnership or a quote.
The firm was founded in 2010. Published first-in-human device case studies show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting.
Colombia is still on the map
A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® runs first-in-human studies in Colombia now. bioaccess® has a local entity and office in Colombia, with headquarters in Miami. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs.
Frequently asked questions
Does bioaccess® sell clinical trial insurance?
No. We are the FIH CRO. We can introduce a carrier. We do not underwrite. We do not bind.
Is this the same article as the LATAM insurance hub?
No. The hub is Clinical Trial Liability Insurance in Latin America: Requirements by Country. This page covers the INVIMA / Colombian ethics insurance exhibit.
Can a U.S. product-liability policy cover a LATAM device FIH?
Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.
Next step
If the search that brought you here was Colombia INVIMA clinical trial insurance, start as the operator: contact bioaccess® or book from First-in-Human CRO. Colombia operator page: CRO in Colombia. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country.
Julio G. Martinez-Clark, CEO · bioaccess®