If you search CRO in Honduras or CRO en Honduras, you should land on the First-in-Human CRO that already runs ARSA work — not a brochure that calls the country an “emerging destination” and stops there.
bioaccess® is that CRO. Headquarters in Miami. The Agencia de Regulación Sanitaria (ARSA) governs device sanitary control under Agreement No. 0631-ARSA-2023. FIH work still needs ARSA authorization, institutional ethics, and an investigational-device import permit. We run clinical trials in Honduras.
I am Julio Martinez-Clark, CEO of bioaccess®. This is the operator page for the query. Colombia, Chile, and Venezuela are sibling country categories. We still run trials in those countries. Honduras is not a replacement for any of them.
What “CRO in Honduras” has to mean
A Honduras CRO for first-in-human devices is not a Central America slide and a courier account. It is a company that can file with ARSA, sit an institutional ethics committee under ISO 14155, keep the investigational-device import permit moving, and stay in the room after first patient in.
That is why this page answers CRO in Honduras / CRO en Honduras as a category, and why it does not list a named Honduran company on the trial hub. The live Honduras ARSA market-access page already says bioaccess® acts as the Honduran representative through our own local entity. That is a registration fact. It is not a hospital we operate, and it is not a reason to mix a commercial file into a first-in-human quote. I am not naming that entity here.
- Miami headquarters — sponsor desk on US Eastern time. Honduras is Central American time, aligned with US Central, already published on the Honduras hub.
- ARSA — Agencia de Regulación Sanitaria, the national health regulation agency.
- Agreement No. 0631-ARSA-2023 — Regulation for the Sanitary Control of Medical Devices. Device registration and technovigilance. Not a standalone clinical-trial regime. Effective 28 December 2023 on the live market-access page.
- FIH pathway — ARSA authorization + institutional EC + investigational-device import permit + ISO 14155 / Helsinki.
- CNTV — National Center for Technovigilance, housed at ARSA, for post-market surveillance.
- ~30% lower versus typical US/EU programs — experience since 2010, not a formal study. Already on the hub.
- 21 CFR 812.28 — eligibility for FDA submission and review is not clearance or approval.
Global Phase 3 networks can list Honduras. They rarely hold the ARSA first-in-human file. A local correspondent can courier a package. That correspondent is not the CRO.
We run trials in Honduras
The category is: who is the CRO in Honduras, and are they actually running studies. We are. We still will. If you are choosing a CRO en Honduras in 2026, ask whether the firm owns the ARSA clock now — not whether someone called the market “emerging.”
ARSA review can move, stall, or come back with questions. First-in-human programs need a start date someone owns. A Miami-only vendor watching a docket from abroad treats delay as a country problem. The CRO that already works ARSA treats delay as responses, ethics alignment, import, and site activation on one timeline.
That is Global Trial Accelerators™ in practice: one accountable operating model across ARSA, institutional ethics, sites, insurance, importation, monitoring, and safety.
ARSA clinical trial: the file, not the myth
ARSA is the Agencia de Regulación Sanitaria. It is Honduras’s national health regulation agency. I am not inventing a PAHO/WHO Level 4 badge for ARSA. llms.txt Regulatory Agencies does not list ARSA. Level 4 is not on that list, and I will not put it here.
Agreement No. 0631-ARSA-2023 is the Regulation for the Sanitary Control of Medical Devices. It governs device registration and technovigilance under ARSA. It is not a standalone clinical-trial law. The live hub already says that. Sponsors who treat 0631 as “the trial regulation” then stall when they discover they still need institutional ethics and an investigational-device import permit.
What the file actually contains, already described on that hub: ARSA authorization, institutional ethics committee approval, an investigational device import permit, and ISO 14155 / Declaration of Helsinki compliance. Foreign sponsors still need someone who can sit the deficiency cycle. bioaccess® serves that role.
Those are authority-and-instrument names. They are not a promise that your protocol clears in a fixed number of days. Ask for a study-specific calendar. We will not publish an invented median on a category page.
Institutional ethics and CNTV
Clinical research in Honduras is reviewed by institutional ethics committees operating under ISO 14155 and the Declaration of Helsinki. Committees evaluate protocols for scientific merit, risk-benefit balance, informed consent adequacy, and patient protection. That paragraph is already on the hub. I am repeating it because sponsors skip ethics and then blame the country.
Ethics sits in front of first patient in. If the committee package is thin, the ARSA clock does not start in a useful way. That is a file problem.
ARSA houses a National Center for Technovigilance (CNTV) responsible for post-market device surveillance, including adverse event reporting. That channel is already on the hub. It is useful when an FIH program later needs a post-market file. It is not a substitute for the trial authorization.
We do not claim to operate a named Honduran hospital.
ARSA registration is a second file — keep it off the trial clock
Clinical-study authorization and commercial device registration are different files. The live Honduras ARSA market-access page already records that Acuerdo No. 0631-ARSA-2023 took effect on 28 December 2023 and requires a local legal representative domiciled in Honduras plus a responsible technical professional at the establishment. It also says bioaccess® acts as the Honduran representative through our own local entity. I am not naming that entity on this category page.
That market-access file is not a first-in-human permit and does not replace ARSA study authorization or institutional ethics. If you later want to sell in Honduras, say so at kickoff so the trial importer and any later representative role are not improvised after first implant. This article does not quote LATAM Launch subscription pricing. That SKU lives on the market-access pages, not on a first-in-human hub.
FDA use of Honduran first-in-human data
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets good clinical practice as that rule defines it, including ethics-committee review and informed consent. bioaccess® designs Honduras studies with that FDA conversation in mind — electronic data capture, structured safety reporting, source data verification — under ISO 14155 with ARSA authorization and institutional ethics approval.
Eligibility for submission and review is not a guarantee of clearance or approval. ISO 14155 is the device GCP standard we align the file to. It is not a stamp the FDA owes you.
Cost — use the number already on the hub
The Honduras hub already publishes ~30% lower versus a comparable US or EU program. I am not inventing a new band here. Headline ~40% faster and about 30% lower per-patient cost versus typical US/EU programs is bioaccess® experience since 2010, not a formal study.
The hub comparison table already publishes Agreement 0631-ARSA-2023 as the device regulation, institutional EC under ISO 14155 / Helsinki, and CNTV as the post-market channel. Those are operating facts. I will not invent a Honduras per-patient dollar band or a start-up week count the hub does not already print.
Questions a sponsor should ask any CRO in Honduras
- Are you running clinical trials in Honduras now — not “historically”?
- Who owns the ARSA clock when the file sits?
- Do you treat Agreement 0631-ARSA-2023 as a standalone trial law, or do you also file institutional ethics and the investigational-device import permit?
- Do you claim ARSA is PAHO/WHO Level 4, or do you stay with what is already published?
- Do you claim to operate a named Honduran hospital, or do you contract sites?
- Is ARSA registration a second file, or are you mixing it into the trial quote?
- Will the study file be built for 21 CFR 812.28, and do you understand that eligibility is not clearance?
bioaccess® answers: trials running; Miami HQ; ARSA and institutional ethics owned as a file problem; 0631 treated as device registration and technovigilance, not as a standalone trial law; no Level 4 invented for ARSA; no named Honduran hospital claimed; ARSA registration kept as a separate market-access file; FDA conversation designed in from day one.
How Honduras sits next to Colombia, Chile, and Venezuela
Do not read this as “leave Colombia.” We still run clinical trials in Colombia. That country has a local Colombian entity and its own hub. Chile has ISP and its own hub. Venezuela has INHRR and its own hub. Honduras is a sibling country category. INVIMA stays INVIMA. ISP stays ISP. INHRR stays INHRR. ARSA stays ARSA. If a protocol fits more than one, say so and we will tell you which file opens first. We will not flip one country into the other.
See clinical trials in Honduras, clinical trials in Chile, clinical trials in Colombia, and clinical trials in Venezuela. The other new category pages in this set: CRO in Uruguay, CRO in Guatemala, and CRO in Bolivia.
How to start
If you need a CRO in Honduras / CRO en Honduras for a first-in-human or early-feasibility device study — or you also need the separate ARSA registration file — contact bioaccess® through bioaccessla.com/contact.
Bring the protocol stage, device class, and whether you also need a Honduran market-access file. We will tell you how the ARSA clock would run. We will not tell you to leave the country. We will not invent a Level 4 badge, a hospital we operate, or a day-count we have not already published.