You picked the Dominican Republic. The hub already publishes institutional REC review at ~30 days and CONABIOS-level review at ~45 days (up to 120 depending on complexity). 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. 6–8 week FIH starts (illustrative) and ethics in a median of 4–8 weeks are the published LATAM figures. Per-patient $15K–$35K versus $40K–$75K typical US/EU; the DR hub also publishes ~30% lower program cost versus US/EU as experience since 2010, not a formal study. 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 | 6–8 week FIH starts (illustrative) 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 ~30 days; CONABIOS ~45 days (up to 120 depending on complexity). 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 | $15K–$35K per patient versus $40K–$75K typical US/EU. Headline ~40% faster / ~30% lower per-patient cost is experience since 2010, not a formal study | The DR hub already publishes ~30% lower program cost versus US/EU as experience since 2010, not a formal study. 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 ~30 days, CONABIOS ~45 days (up to 120). 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 published REC ~30 / CONABIOS ~45 (up to 120) clocks. This compare is the country-2 intercept after a DR first-in-human.
The hub already publishes institutional REC review at ~30 days and CONABIOS-level review at ~45 days (up to 120 depending on complexity). 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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