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 No unpublished client.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 Bioforum Israel FIH device CRO, Bioforum medical device first-in-human, Bioforum Pi-Cardia LATAM, you were looking for a first-in-human / early-feasibility medical-device CRO in Israel. 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.
Bioforum is on the named AU/IL/CA set because it is a data-focused CRO with a Melbourne office and an Israel base. Locked device-adjacent cases are biometrics, not bioaccess®-style hospital FIH ops. Pi-Cardia ShortCut™ (leaflet-modification for valve-in-valve TAVR) is named, FDA-cleared, Breakthrough Device; Bioforum’s published role is data / stats / FDA package; EU → US site expansion on that page; not an Australia ops case. ShortCut itself is cleared — do not pitch a redo. Steal is Pi-Cardia’s next leaflet / valve-in-valve / next-gen EFS operations in LATAM if that protocol exists. We will not invent it onto this page as if it were already signed.
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 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
Ibex Prostate Detect is a named AI/SaMD 510(k) client (stats + data management + site monitoring on Bioforum’s congratulations page; Ibex also notes TGA and ANVISA registrations on its own clearance copy). Already cleared. Steal would be a LATAM clinical-performance / next-indication study, and only if that study is a true early device protocol — not a 510(k) follow-on we pad into a five-trial goal. MeMed BV® on MeMed Key® is a named host-response IVD (FDA 510(k) Sep 2021); Bioforum role is EDC + CEC + CSR. Country of APOLLO sites is not stated on the Bioforum page. Asset already cleared.
What is excluded on purpose
Abiomed Impella post-approval data partnership (from Jun 2019; PAS figures are Abiomed’s published numbers, not a Bioforum FIH). Dren Bio DR-01 is a drug EDC case. Neither is an Israel hospital-implant FIH we can steal. We will not add extra CRO brands. We will not name NextLife.
Israel-only NCT rows are the sibling page
This intercept is the Bioforum operator. Israel-only or Canada-only device NCT geography is the combined second-country page — one page, not a ninth. Do not split it.
Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA
A data CRO package does not import an investigational implant into Panama. If the next protocol needs ISO 14155 field-clinical in Latin America, that is a different operator. Country 2 is not a new Colombian FIH CTA.
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 Bioforum Israel as the FIH device CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling NCT page: Israel- or Canada-only NCT → LATAM.
Julio G. Martinez-Clark, CEO · bioaccess®