You picked the Dominican Republic. The hub already publishes institutional REC review on a timeline that varies by study (we confirm it per protocol) and CONABIOS-level review on a timeline that varies by study (we confirm it per protocol). DIGEMAPS is the named regulator. We will not invent a new DR median and we will not invent a Miami–DR flight-hour figure. Ask for a study-specific calendar. If you need country 2 — Panama, El Salvador, Chile, Brazil, or another jurisdiction we already run — bioaccess® is the same First-in-Human CRO on that next file. First-patient timing varies by study (we confirm it per protocol) and ethics in a median of 4–8 weeks are the published LATAM figures. A public hop exists: Dominican Republic, then Australia, then Canada, then an FDA conversation. We describe the pattern. We do not name the sponsor.
| Metric | bioaccess® | Dominican Republic |
|---|---|---|
| Role on this page | Country 2 / the rescue or expansion path — the same First-in-Human CRO on the next LATAM file | Country 1 — the Dominican Republic you already picked. The CRO hub is /clinical-trials-dominican-republic, not this compare |
| Start-up clock | First-patient timing varies by study (we confirm it per protocol) and ethics in a median of 4–8 weeks on the wider LATAM list. Country-2 clocks are asked as a study-specific calendar | Hub clocks only: institutional REC (varies by study; we confirm per protocol); CONABIOS (varies by study; we confirm per protocol). We will not invent a new DR median |
| Regulator already named | INVIMA, COFEPRIS, ANVISA, ANMAT, ISP, MINSA, DIGEMAPS and the other authorities already on the country hubs — matched to the second country | DIGEMAPS (Ministry of Public Health) and CONABIOS — already on the DR hub. We will not invent a second regulator |
| Per-patient / program cost | Budget depends on study design; we provide a study-specific quote. | The DR hub already publishes No new figure here |
| Entity | None to stand up for the trial file on this intercept. Contract and start | This page does not invent a Dominican clinical-trial legal entity. The market-access page already states a Dominican entity for the Authorized Representative / registration-holder role — that is a second file |
| FDA acceptance & data applicability | Data conducted under GCP (ISO 14155 for devices; ICH E6 for drugs) is eligible for FDA submission and review under 21 CFR 812.28 or 312.120. Eligibility is not clearance or approval | The hub already states the same 21 CFR 812.28 eligibility for Dominican Republic data when GCP, ethics, and consent are met |
| Distance & time zone from the U.S. | Same or adjacent U.S. time zones; ~3–8 hour flights on the published LATAM compare (Australia page) | The hub already publishes direct US flights and US East Coast time-zone alignment. We will not invent a Miami–DR flight-hour figure |
| Where the hub is the better page | Country 2 — Panama, El Salvador, Chile, Brazil, or another jurisdiction we already run | CRO in the Dominican Republic / CRO en República Dominicana — that category lives on /clinical-trials-dominican-republic |
Comparison uses widely-known category facts about Dominican Republic and published US/EU benchmark ranges — not Dominican Republic-specific figures. bioaccess® figures reflect our FIH-12™ operating model.
You picked the Dominican Republic. The CRO-in-DR hub already answers that category: Miami headquarters, DIGEMAPS, CONABIOS, REC (varies by study; we confirm per protocol), CONABIOS (varies by study; we confirm per protocol). This compare does not duplicate that hub. If you only need the Dominican Republic file, go there.
This page is country 2. Another Latin American jurisdiction after a DR first-in-human, or a hop out of region. bioaccess® is the same First-in-Human CRO on that next file. We do not invent a Dominican clinical-trial legal entity here. We do not invent a Miami–DR flight-hour figure. Direct US flights and US East Coast time-zone alignment are already on the hub.
A public hop exists: Dominican Republic, then Australia, then Canada, then an FDA conversation. We describe the pattern. We do not name the sponsor, the device, or commercial terms. bioaccess® is built for the Latin American legs of a hop like that.
Foreign device data is eligible for FDA submission and review under 21 CFR 812.28 when GCP / ISO 14155, ethics, and consent are met. Eligibility is not clearance or approval. Ask for a study-specific calendar. We will not invent a new DR median on this intercept.
No. The hub is /clinical-trials-dominican-republic. That page owns CRO in the Dominican Republic / CRO en República Dominicana, DIGEMAPS, CONABIOS, and the REC and CONABIOS review steps (timing varies by study; we confirm per protocol). This compare is the country-2 intercept after a DR first-in-human.
The hub already publishes institutional REC review on a timeline that varies by study (we confirm it per protocol) and CONABIOS-level review on a timeline that varies by study (we confirm it per protocol). This intercept will not invent a new median. Ask for a study-specific calendar.
We will not invent a Miami–DR flight-hour figure. The hub already publishes direct US flights and US East Coast time-zone alignment. That is the published fact.
A public multi-country hop exists: a first-in-human start in the Dominican Republic, then Australia, then Canada, then an FDA conversation. We describe the pattern. We do not name the sponsor, the device, or commercial terms. bioaccess® is built for the Latin American legs of a hop like that.
You only need the CRO-in-Dominican-Republic category — DIGEMAPS, CONABIOS, sites already named on that hub, and the published clocks. Go to /clinical-trials-dominican-republic. Use this compare when country 1 is the Dominican Republic and you need country 2.
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