You picked Israel. 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 an Israel start-up median. Ask for a study-specific calendar. 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® | Israel |
|---|---|---|
| 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-Israel 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 an Israel 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 an Israel per-patient figure. US/EU benchmark on this site is $40K–$75K |
| Entity | None to stand up — contract and start | bioaccess® does not invent an Israeli 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 — the same rule applies if country 1 is Israel |
| 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–Israel 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 that file is moving, stay on it |
Comparison uses widely-known category facts about Israel and published US/EU benchmark ranges — not Israel-specific figures. bioaccess® figures reflect our FIH-12™ operating model.
You picked Israel. That is a real first-in-human destination. This page does not talk you out of it. It answers the next question: what if country 1 stalls, queues, or does not give you a dataset you can take to FDA or to a raise.
bioaccess® is the First-in-Human CRO. Miami headquarters. U.S. regulatory anchoring plus Latin American execution. We do not invent an Israeli legal entity. We do not invent an Israel start-up median. 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.
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. 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, and it does not turn on Israel either.
If Israel is moving, stay. If you need country 2, Latin America is the rescue path. Book a 30-minute feasibility call. You leave with a country, a timeline, and a budget read — not a pitch.
No. This is a destination intercept. You already picked Israel as country 1. bioaccess® is the First-in-Human CRO — Miami headquarters, U.S. regulatory anchoring plus Latin American execution. Latin America is country 2 / the rescue path. We do not invent an Israeli legal entity on this page.
We will not invent an Israel 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.
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, not by the country of origin. Eligibility is not clearance or approval. FDA and PMDA assess data applicability case-by-case regardless of whether the trial runs in Latin America, Australia, or Canada — the same rule applies if country 1 is Israel.
Israel 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 — cash-basis LATAM cost, no foreign entity, 6–8 week illustrative FIH starts — without inventing an Israel clock we do not have.
All CRO comparisons · First-in-Human CRO · Clinical Trials in Panama · Book a free 30-min strategy call