General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.
If you searched Israel-only NCT device trial, Canada-only NCT medical device, second country Latin America FIH EFS, you were looking for a first-in-human / early-feasibility medical-device CRO in Israel or Canada. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.
One page, two geography patterns, not a ninth slug. Device protocols that sit only in Israel, or only in Canada, still have a country-2 problem: the next n does not have to wait on another Helsinki or Health Canada cycle if Latin America can run ISO 14155 hospital implant or interventional ops. We cover both on this slug. We do not split Israel and Canada into two posts until Julio asks.
This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Israel or Canada if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.
What this search is actually buying
Israel-only is not Bioforum. Canada-only is not Avania and not JSS. Those brands have their own intercepts. This page is the NCT geography. We will not invent a named Israeli or Canadian device study here beyond what the locked CRO files already allowed on sibling pages. Remedy N1 at Unity Health Toronto is named on the Avania Canada page because Avania published it; we do not duplicate that case as if it were an NCT-only steal. JSS still has zero public device cases — we will not fill that gap here.
What country 2 is for an Israel-only protocol
A Ministry of Health Israel authorization does not import an investigational device into Panama or Brazil. Ethics language, ICF, and insurance exhibits have to be rebuilt for the Latin American committee. Bioforum’s published device-adjacent work is data / FDA package / 510(k) — not a reason to skip field-clinical. Pi-Cardia ShortCut is cleared; do not redo it. Next early protocol only.
What country 2 is for a Canada-only protocol
Health Canada CTA is not MINSA, ISP, ANVISA, or COFEPRIS. Unity Health is not a Latin American site. A Montréal MSA (JSS or otherwise) is not ISO 14155 in Santiago or Panama City. If Avania already ran country 1 in Toronto, keep them on country 1; add Latin America for the expansion. Do not rip a live protocol. Do not mix Magical BTK. Do not name HDI.
Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA
Do not default country 2 to a new Colombian FIH. INVIMA registro remains. Use Panama, Chile, Brazil, Mexico, or El Salvador for new FIH execution on this cluster. Do not publish a ninth Israel-only hospital page or a ninth Canada-only hospital page from this brief.
Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.
Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.
Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.
Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.
El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.
Colombia stays market access
Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.
Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.
What bioaccess® still owns on the steal
- ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
- Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
- Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
- 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
- No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.
The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.
Frequently asked questions
Is bioaccess® trying to replace the incumbent CRO on a live protocol?
No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.
Do you sell clinical trial insurance on this page?
No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.
Is Colombia the country-2 default?
No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.
Next step
If the search that brought you here was Israel-only or Canada-only device NCT → LATAM as country 2, start as the operator: contact bioaccess® or book from First-in-Human CRO. Siblings: Bioforum Israel, Avania Canada, JSS Canada.
Julio G. Martinez-Clark, CEO · bioaccess®