You picked Canada. Health Canada may be named as the regulator — that name is already on live bioaccess® pages. We will not invent a Health Canada ITA/CTA median. Ask for a study-specific calendar. 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. FDA and PMDA assess data applicability case-by-case whether the trial runs in Latin America, Australia, or Canada. A public multi-country hop exists — Dominican Republic, then Australia, then Canada, then an FDA conversation. We describe the pattern. We do not name the sponsor.
| Metric | bioaccess® | Canada |
|---|---|---|
| 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. Health Canada is the named regulator. This is not a CRO-in-Canada 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 Health Canada ITA/CTA 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 Canada 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 Canadian 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) | Canada sits in the same North American time-zone conversation as Miami. We will not invent a flight-hour figure |
| Where it is genuinely stronger | Lowest cash-basis LATAM cost, no foreign entity, same region for later patient-phase work | Health Canada is a named reference regulator already used in this site's COFEPRIS reliance language. English-language North American operations. If that file is moving, stay |
Comparison uses widely-known category facts about Canada and published US/EU benchmark ranges — not Canada-specific figures. bioaccess® figures reflect our FIH-12™ operating model.
You picked Canada. Health Canada is the regulator already named on live bioaccess® pages — Mexico's COFEPRIS equivalence route lists FDA, Health Canada, and Japan as reference authorities. Naming Health Canada here is not a new claim. Inventing an ITA or CTA median would be. We will not do that. Ask for a study-specific calendar.
bioaccess® is the First-in-Human CRO. Miami headquarters. U.S. regulatory anchoring plus Latin American execution. We do not invent a Canadian legal entity. 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.
A public multi-country hop exists: Dominican Republic, then Australia, then Canada, then an FDA conversation. That is a pattern. We do not name the sponsor, the device, or commercial terms. If your program needs country 2 after Canada — or a LATAM hop before Canada — bioaccess® is built for the Latin American legs.
FDA and PMDA assess whether foreign data apply to their populations case-by-case. That question does not turn on whether you run in Latin America, Australia, or Canada. 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.
No. This is a destination intercept. You already picked Canada as country 1. Health Canada is named because that regulator is already on live bioaccess® pages. bioaccess® is the First-in-Human CRO — Miami headquarters, U.S. regulatory anchoring plus Latin American execution. We do not invent a Canadian legal entity on this page.
We will not invent a Health Canada ITA/CTA 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.
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.
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 — not as a claim that we ran every country on that path.
Canada is the only geography your protocol and regulatory plan will accept, Health Canada authorization is the milestone that funds the next step, and that file is moving. Stay. bioaccess® is the better fit when you need a second country on a startup runway without inventing a Health Canada clock we do not have.
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