You picked the Czech Republic. Keep it if it is moving. If you need a second country, bioaccess® runs first-in-human across Latin America from Miami: 6–8 week FIH starts (illustrative), ethics in a median of 4–8 weeks, per-patient $15K–$35K versus $40K–$75K typical US/EU. Headline ~40% faster / ~30% lower per-patient cost is experience since 2010, not a formal study. We will not invent a Czech start-up median. Ask for a study-specific calendar. This page does not claim that RQM+ last first-in-human was in the Czech Republic. 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.
| Metric | bioaccess® | Czech Republic |
|---|---|---|
| Role on this page | Country 2 / the rescue path — U.S. regulatory anchoring + Latin American execution from Miami | Country 1 — the destination you already picked. This is not a CRO-in-Czech-Republic page |
| Start-up clock | 6–8 week FIH starts (illustrative). Ethics 4–8 weeks median. Argentina ANMAT review is capped by Disposition 7516/2025 (Annex III) at ~35 technical + 10 administrative business days (≈45) for Phase I / non-low-risk studies — ~30 for low-risk — with ethics in parallel; queries pause the clock | We will not invent a Czech start-up median. Ask for a study-specific calendar |
| Per-patient cost | $15K–$35K in Latin America. Headline ~30% lower versus typical US/EU is experience since 2010, not a formal study | We will not invent a Czech per-patient figure. US/EU benchmark on this site is $40K–$75K |
| Entity | None to stand up — contract and start | bioaccess® does not invent a Czech legal entity on this page |
| 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 | Also eligible when GCP, ethics, and consent are met. FDA and PMDA assess data applicability case-by-case, regardless of whether the trial runs in Latin America, Australia, or Canada |
| Distance & time zone from the U.S. | Same or adjacent U.S. time zones; ~3–8 hour flights (already published on the Australia compare) | We will not invent a Miami–Czech Republic flight-hour figure |
| Where it is genuinely stronger | Lowest cash-basis LATAM cost, no foreign entity, same region for later patient-phase work | It is the country you already picked. If your later pivotal is EU-bound and that file is moving, stay. This page does not claim a named CRO last ran first-in-human there |
Comparison uses widely-known category facts about Czech Republic and published US/EU benchmark ranges — not Czech Republic-specific figures. bioaccess® figures reflect our FIH-12™ operating model.
You picked the Czech Republic. That is country 1. This page does not talk you out of it. It does not invent a Czech start-up median. It does not claim that RQM+ last first-in-human was in the Czech Republic. That claim is not on this page.
bioaccess® is the First-in-Human CRO. Miami headquarters. U.S. regulatory anchoring plus Latin American execution. We do not invent a Czech legal entity. Ask for a study-specific calendar. The clocks we will repeat are already public: 6–8 week FIH starts (illustrative), ethics in a median of 4–8 weeks, per-patient $15K–$35K versus $40K–$75K typical US/EU. ~40% faster / ~30% lower per-patient cost is experience since 2010, not a formal study.
If you need EU MDR/IVDR regulatory-and-quality work across the device lifecycle, that is a different job than this intercept. The live RQM+ compare already frames that category. This page does not reopen it as a Czech first-in-human claim.
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. If the Czech file is moving, stay. If you need country 2, Latin America is the rescue path.
No. This is a destination intercept. You already picked the Czech Republic as country 1. bioaccess® is the First-in-Human CRO — Miami headquarters, U.S. regulatory anchoring plus Latin American execution. We do not invent a Czech legal entity on this page.
We will not invent a Czech start-up median. Ask for a study-specific calendar. The clocks we publish are Latin American: 6–8 week FIH starts (illustrative) and ethics in a median of 4–8 weeks.
This page does not publish that claim. The live RQM+ compare frames RQM+ as a MedTech regulatory, quality, clinical, and reimbursement firm anchored in the U.S. and EU. It does not state a last first-in-human country. We will not invent one here.
Foreign clinical data from either region can support a U.S. submission when it meets the applicable requirements (21 CFR 812.28 for devices, 21 CFR 312.120 for drugs, conducted under GCP). Acceptance is determined by the FDA case-by-case. Eligibility is not clearance or approval.
The Czech Republic is the only geography your protocol and regulatory plan will accept, and that file is moving. Stay. bioaccess® is the better fit when you need a second country on a startup runway without inventing a Czech clock we do not have.
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