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 No unpublished client.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 Australia-only NCT medical device, second country Latin America FIH, CTN only device trial add LATAM, you were looking for a first-in-human / early-feasibility medical-device CRO in Australia. 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.
Some device protocols sit on ClinicalTrials.gov with Australia as the only country. That row is country 1. It is not a reason the next n has to wait on another CTN. Country 2 is Latin America: Panama, Chile, Brazil, Mexico, or El Salvador as the device needs. This page is not an Avania, Novotech, or GreenLight Clinical clone. Those operator intercepts are separate slugs. This intercept is the geography pattern.
This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Australia 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
An Australia-only NCT location list is a snapshot, not a regulatory strategy. TGA/CTN does not import into MINSA, ISP, ANVISA, or COFEPRIS territory. A second Australian private hospital is not country 2. We will not scrape a new named sponsor list onto this page from CT.gov. We will not invent enrollment counts from a LATAM-only dump. If your protocol is already Australia-only, the operator question is whether the next amendment or the next protocol should add Latin America.
Do not use leftover Australian campuses as the pitch
Leftover-site FIH hospital pages are a different cluster and batch 42 stays waiting. Do not email an Australian NCT facility and ask them to become a Latin American site. Do not treat R&DTI as a substitute for ISO 14155 monitoring in Panama. Do not add NextLife. Nanochon stays HOLD.
Historic Alessa is not this page
NCT04284761 (Alessa Biolen-PC) listed Australia + New Zealand and later a US site; it is completed. Mentioned only as historic next-protocol context on the Avania AU page. It is not an Australia-only live steal and not a mail we send from here.
Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA
Add country 2 before the protocol is frozen if the FDA-bridge story needs more n, more anatomy, or a backup geography when ANZ slots fill. Use the live clocks below. Do not default to a new Colombian FIH.
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 Australia-only device NCT → LATAM as country 2, start as the operator: contact bioaccess® or book from First-in-Human CRO. Operator CROs in this cluster: Avania, Novotech, GreenLight Clinical.
Julio G. Martinez-Clark, CEO · bioaccess®