You picked New Zealand. 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 New Zealand start-up median. Ask for a study-specific calendar. We will not invent a Miami–New Zealand flight-hour figure. 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. Australia's 43.5% R&D tax offset is an Australia fact — it is not restated here as a New Zealand incentive.
| Metric | bioaccess® | New Zealand |
|---|---|---|
| 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-New-Zealand page and not the Australia compare |
| 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 New Zealand or Medsafe 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 New Zealand per-patient figure. US/EU benchmark on this site is $40K–$75K. We will not move Australia's rebate onto this page |
| Entity | None to stand up — contract and start | bioaccess® does not invent a New Zealand 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–New Zealand flight-hour figure. The Australia compare already states ~14–20+ hour travel and a 14–18 hour time difference for that region |
| Where it is genuinely stronger | Lowest cash-basis LATAM cost, no foreign entity, same region for later patient-phase work | English-language operations in the country you already picked. If that file is moving, stay. For the Australian rebate, use /compare/australia |
Comparison uses widely-known category facts about New Zealand and published US/EU benchmark ranges — not New Zealand-specific figures. bioaccess® figures reflect our FIH-12™ operating model.
You picked New Zealand. That is country 1. This page does not talk you out of it and it does not steal Australia's R&D tax incentive. The 43.5% refundable offset on /compare/australia is an Australia fact. We will not restate it as a New Zealand incentive.
bioaccess® is the First-in-Human CRO. Miami headquarters. U.S. regulatory anchoring plus Latin American execution. We do not invent a New Zealand legal entity. We will not invent a Medsafe clock. 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.
We will not invent a Miami–New Zealand flight-hour figure. The Australia compare already publishes ~14–20+ hour travel and a 14–18 hour time difference for that region. Latin America adds same- or near-U.S. time zones and ~3–8 hour flights — those figures are already on the Australia page.
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 New Zealand is moving, stay. If you need country 2, Latin America is the rescue path.
No. This is a destination intercept. You already picked New Zealand 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 New Zealand legal entity on this page.
We will not invent a Medsafe or New Zealand 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 will not say that. The 43.5% refundable R&D tax offset is an Australia fact on /compare/australia. We will not move it onto New Zealand.
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. FDA and PMDA assess data applicability case-by-case regardless of whether the trial runs in Latin America, Australia, or Canada. Eligibility is not clearance or approval.
New Zealand is the only geography your protocol and regulatory plan will accept, and that file is moving. Stay. If you came for the Australian rebate, go to /compare/australia. bioaccess® is the better fit when you need a second country on a startup runway without inventing a New Zealand clock we do not have.
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