General information, not insurance, legal, or regulatory advice. Confirm current DIGEMAPS 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 No unpublished client.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 Dominican Republic clinical trial coverage, DIGEMAPS trial insurance, DR FIH 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 We do not quote a binder.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.
The Dominican Republic is a public bioaccess® geography (DIGEMAPS on llms.txt; live hub at clinical-trials-dominican-republic). Public Resurge Therapeutics copy already names a Dominican Republic FIH as an investigational platform — not a reason to invent a premium, and not a reason to treat bioaccess® as the carrier. Compare pages exist so a DR-first protocol can add LATAM country 2; this slug is coverage, not that compare.
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 DIGEMAPS / Dominican 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/DIGEMAPS packet, importer of record for clinical trial devices in Latin America, ISO 14155 monitoring, SAE clock, TMF, and the 21 CFR 812.28 narrative. See OUS FIH and FDA IDE. Eligibility of foreign data is not FDA clearance.
Mixing those jobs is how a startup buys a U.S. product-liability rider, emails a PDF to an ethics committee, and gets a resubmission. Product liability is not clinical-trial liability. A site’s institutional policy is not the sponsor’s trial form.
Use the live DR hub. Do not invent a new clock
Cite clinical-trials-dominican-republic. We will not invent a DIGEMAPS insurance tariff. Ethics still files a certificate. Spanish language is the usual ask. A hallway conversation in Santo Domingo is not that exhibit. Leftover-site 43 is campuses, not this intercept.
Investigational public copy is not a rate card
Resurge IPDE™ public copy is a named DR FIH workstream on llms.txt. It is investigational. It is not a binder we resell. Do not mix Magical BTK. Do not name HDI as a signed partner.
What ethics and DIGEMAPS actually ask for
Use the live Dominican Republic country page. We will not invent unpublished DIGEMAPS clocks or premiums here.
Insurance documentation is usually in the ethics / DIGEMAPS packet, not a post-approval formality. Typical asks (confirm with the reviewing body — we will not invent a pan-regional limit):
- Territory that names every country on the protocol.
- Site and principal investigator as additional insureds when the committee requires it.
- Policy period through last-patient last-visit plus the protocol follow-up window.
- Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
- Claims-notice language that can sit next to the SAE clock, not against it.
We will not invent a per-participant dollar figure on this page. Individual ethics committees set thresholds. Ask the carrier and the CRO together, before the packet goes in.
Local policy vs controlled master
A master that excludes the Dominican Republic fails ethics. A DR-only local policy that cannot add Panama later is a trap if the protocol expands. New Colombian FIH execution is not the recommendation on the public line.
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. The DR compare hub is a country-2 intercept after a DR first-in-human, not a second CRO-in-DR page. This page is coverage only.
- Protocol, IB, ICF, and the ethics / DIGEMAPS 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
Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. 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 DIGEMAPS / Dominican 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 Dominican Republic clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. DR operator: clinical-trials-dominican-republic. Hub: Clinical Trial Insurance in Latin America: What Sponsors Need to Know Before Study Start.
Julio G. Martinez-Clark, CEO · bioaccess®