Category: Preparing for First-In-Human Studies

Sources: Arissa Medical press release of 8 October 2026 (arissamedical.com), NeuroNews International coverage of 8 October 2026 and 22 January 2024, and a ClinicalTrials.gov search run 15 October 2026. Public sources only. This page does not claim that bioaccess® ran, monitored, or advised on the Syntra study, and it does not claim the institute or its investigators as bioaccess® clients. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers.

If you searched Instituto de Neurocirugía Asenjo first-in-human, Instituto de Neurocirugía Dr. Alfonso Asenjo clinical trial, INCA Santiago neurovascular study, or “go direct to the Asenjo institute for an aneurysm device,” you found a real site. The Instituto de Neurocirugía Dr. Alfonso Asenjo in Santiago, Chile, is the public neurosurgery institute Arissa Medical names as the only site of its Syntra™ intrasaccular-device pilot. It is a serious neurovascular center. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package, plus the option to add another Latin American country if one neurovascular center is not enough. Sponsors who skip the CRO and email the cath lab still have to rebuild that stack.

What the public record says

• NeuroNews International, 22 January 2024: Arissa Medical enrolled the first patients in its first-in-human, early feasibility Syntra study for wide-necked sidewall and bifurcation cerebral aneurysms. Initial cases were done at the Instituto de Neurocirugía Dr. Alfonso Asenjo in Santiago by interventional neuroradiology principal investigator Dr. Juan Gabriel Sordo. Source.
• Arissa Medical, 8 October 2026: 12-month digital subtraction angiography follow-up was complete for all 16 patients in the prospective, single-arm pilot. The release reports 100% technical success, adequate occlusion (Raymond-Roy I–II) in 15 of 16 patients, zero retreatments, and zero device-related serious adverse events. It names the institute as the pilot site and Dr. Sordo as principal investigator, and it thanks Dr. Rodrigo Rivera, Chief of Neuroradiology, and the institute’s catheterization lab staff. Source; NeuroNews coverage.
• Study oversight named in the release: a UCLA-affiliated independent medical monitor and a blinded core lab. The release names no CRO. Arissa says it will seek FDA Breakthrough Device designation after the pilot closes. Syntra is limited to investigational use.
• ClinicalTrials.gov: a search on 15 October 2026 found no Syntra or Arissa record. The institute’s name does appear on older registry rows, such as the CHUM-sponsored TOBAS (NCT02098252) and PRET (NCT00626912) studies. We cite them only as facility evidence.

That is the leak: a founder reads a 16-patient neurovascular feasibility result, sees one Santiago institute and one PI, and no CRO, and concludes the hospital ran the whole study. It did not run the regulatory stack on its own. Something always owns import, insurance, monitoring, and the dataset an FDA reviewer will ask about.

The site is the site. The CRO is the operator.

What a neurovascular institute can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether the aneurysm caseload fits the protocol.
• Share institutional ethics and research-office calendars.
• Run the cases in its biplane cath lab with its neuroradiology team.

What the institute is not built to own for an investigational device:

• ISP and ethics. The investigational-device import and study authorization file, plus the Law 20.120 committee packet and every amendment.
• Investigational import. Permits, customs, and device accountability. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review once GCP and ethics documentation is in place. Eligibility is not clearance, and a site agreement does not produce it.

How ISP actually works (the short version)

Use clinical trials in Chile and Chile ISP: device vs. drug clinical trials. The Instituto de Salud Pública (ISP) governs investigational-device import and study authorization in Chile. An accredited Ethical-Scientific Committee under Law 20.120 still has to review the protocol, and a public hospital adds its own institutional authorization and research-office steps. Commercial ISP registration is a different file. Do not put trial authorization and commercial registration on one Gantt labeled “Chile.”

All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis. Eligibility is not a guarantee of clearance or approval. See OUS FIH data and the FDA IDE.

Not a critique of the hospital

The Instituto de Neurocirugía Dr. Alfonso Asenjo is one of Chile’s reference neurosurgery centers, and the Syntra pilot shows its team can run a first-in-human neurovascular program. Use the site when the protocol fits. Hire the operator. This page is distinct from Clínica Santa María Santiago, where Dr. Sordo has also been listed, and from Clínica Alemana de Santiago. Sharing Santiago is not a license to merge them. The investigator-level page is Dr. Juan Gabriel Sordo: a Chile FIH principal investigator is not the CRO.

bioaccess® still runs clinical trials in Colombia

bioaccess® is the First-in-Human CRO for medical devices in Latin America, founded in 2010, with Miami headquarters and its own CRO in Colombia. bioaccess® still runs clinical trials in Colombia as well as Chile, Panama, and the rest of the platform. We pick the country the device needs.

Frequently asked questions

Can I contract the Instituto de Neurocirugía Asenjo directly for a device FIH?

You can start the conversation there. The institute can discuss investigator interest, caseload, and ethics calendars. It does not become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because it hosted a pilot. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® work on the Arissa Syntra study?

No. This page reports public sources only and claims no role in that study.

Is Syntra on ClinicalTrials.gov?

Not as of a 15 October 2026 search. A sponsor-named site with no CRO in the story is exactly why this page exists.

Next step

If the search that brought you here was this institute, start with the operator: contact bioaccess® or see First-in-Human CRO.

Julio G. Martinez-Clark, CEO · bioaccess®

If you typed George Clinical (Emerald Clinical) into a search box, you are probably building a CRO shortlist. This article uses only what George Clinical (Emerald Clinical) publishes (georgesclinical.com/therapeutic-expertise/medical-devices-cro · emeraldclinical.com · emeraldclinical.com/about-us) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What George Clinical (Emerald Clinical) publishes

George Clinical came out of The George Institute in Australia and in 2025 became Emerald Clinical Trials, which says it is headquartered in Singapore. George Clinical's medical device page covers feasibility, pilot, Class II/III pivotal and post-market studies, and describes it as a specialized CRO in Asia-Pacific and the USA. Emerald says it has completed 600+ trials across 70+ geographies over more than 25 years, with strength in renal, cardiovascular and oncology research.

George Clinical (Emerald Clinical) vs bioaccess®

Dimension	George Clinical (Emerald Clinical)	bioaccess®
Core focus	APAC-origin full-service CRO, late-phase strength	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Post-market studies and surveillance, plus regulatory and pharmacovigilance services	Live multi-country sanitary registration and in-country holder service

Where each one fits

If the device program is a large pivotal or post-market study across Asia-Pacific, George / Emerald is a capable choice.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including George Clinical (Emerald Clinical), for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not George Clinical (Emerald Clinical) features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the George Clinical (Emerald Clinical) public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Biointelect into a search box, you are probably building a CRO shortlist. This article uses only what Biointelect publishes (www.biointelect.com/cro) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Biointelect publishes

Biointelect is a Sydney consultancy founded in 2011 that added a CRO. It lists medical devices among its therapeutic areas, plus first-in-human, Phase I–II and high-risk inpatient studies, and leans toward strategy, local sponsor and regulatory work. Leah Goodman is CEO.

Biointelect vs bioaccess®

Dimension	Biointelect	bioaccess®
Core focus	Australian consulting + CRO + local sponsor	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Australian market entry support: legal local sponsor, TGA submissions, Resident Director services and R&D Tax Incentive coordination	Live multi-country sanitary registration and in-country holder service

Where each one fits

If what you need is an Australian entity, local sponsor and R&D tax-incentive coordination around a Phase I unit, Biointelect fits.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Biointelect, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Biointelect features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Biointelect public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Datapharm Australia into a search box, you are probably building a CRO shortlist. This article uses only what Datapharm Australia publishes (datapharmaustralia.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Datapharm Australia publishes

Datapharm Australia, in Drummoyne, Sydney, calls itself Australia's original full-service CRO, founded in 1987. Its therapeutic list includes devices, diagnostics and first-in-humans, and its cardiovascular page cites implants and stents. Helen Allars and John Edington are its co-founders.

Datapharm Australia vs bioaccess®

Dimension	Datapharm Australia	bioaccess®
Core focus	Mid-market single-country Australian CRO, drug and device	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Phase IV post-marketing and observational studies, and pharmacovigilance services	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need a single-country Australian device or first-in-human study with a long-established local CRO, Datapharm fits.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Datapharm Australia, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Datapharm Australia features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Datapharm Australia public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed iNGENū CRO into a search box, you are probably building a CRO shortlist. This article uses only what iNGENū CRO publishes (ingenucro.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What iNGENū CRO publishes

iNGENū CRO is a Melbourne, physician-led biotech CRO led by CEO Dr Sud Agarwal. It sells fixed-milestone pricing, claims costs 80–90% below US CROs and 30–60% below other Australian CROs, and about four-week ethics. In September 2025 it was named CRO for Sapu Nano's Sapu003 human trials.

iNGENū CRO vs bioaccess®

Dimension	iNGENū CRO	bioaccess®
Core focus	Lean Australian biotech CRO, drug-primary	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	FDA regulatory services and Phase 1–4 trials listed	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you are a lean US biotech looking for a low-cost Australian Phase 1, iNGENū is built for that.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including iNGENū CRO, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not iNGENū CRO features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the iNGENū CRO public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Accelagen into a search box, you are probably building a CRO shortlist. This article uses only what Accelagen publishes (accelagen.com.au) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Accelagen publishes

Accelagen is a Melbourne regulatory and clinical firm founded in 2010 that can act as local sponsor. It markets to first-time and seed-stage sponsors of devices and small molecules. It publishes a case of ethics approval in 42 days for a US medical device company after two earlier rejections (sponsor not named), and first-in-human cases including Memo Therapeutics' anti-BKV therapy.

Accelagen vs bioaccess®

Dimension	Accelagen	bioaccess®
Core focus	Australian RA + CRO + local sponsor	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Regulatory strategy, approvals and lifecycle-management planning across Asia-Pacific and North America	Live multi-country sanitary registration and in-country holder service

Where each one fits

If this is your first Australian trial and you want regulatory, local sponsor and CRO in one boutique, Accelagen fits.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Accelagen, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Accelagen features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Accelagen public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Southern Star Research into a search box, you are probably building a CRO shortlist. This article uses only what Southern Star Research publishes (southernstarresearch.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Southern Star Research publishes

Southern Star Research is a Sydney CRO founded in 2010 that runs full-service Phase I–IV work, positioned around early-phase biotech plus medical device clients. It claims 4–8 week start-up through Phase I unit relationships. Lloyd Prescott is CEO and Dr David Lloyd is founder and Managing Director. We found no named sponsor first-in-human press release on its site.

Southern Star Research vs bioaccess®

Dimension	Southern Star Research	bioaccess®
Core focus	Boutique Australian Phase I–IV CRO	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Continuity from first-in-human through Phase II and pivotal Phase III	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you are a seed-to-Series B sponsor wanting an Australian specialist rather than a large CRO, Southern Star is a fair choice.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Southern Star Research, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Southern Star Research features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Southern Star Research public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Avance Clinical into a search box, you are probably building a CRO shortlist. This article uses only what Avance Clinical publishes (www.avancecro.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Avance Clinical publishes

Avance Clinical is an Adelaide-headquartered biotech CRO, formerly the clinical arm of CPR Pharma, with operations in Australia, New Zealand, Asia, North America and Europe. In January 2025 Avance said it was CRO of record on more than 52% of active Phase I trials on ANZCTR and that more than 80% of its clients are US biotechs. It runs an Early Phase Center of Excellence that places studies into Australian Phase I units.

Avance Clinical vs bioaccess®

Dimension	Avance Clinical	bioaccess®
Core focus	Biotech full-service CRO, early phase	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you are a US biotech running an Australian Phase I drug trial, Avance is one of the most established choices.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Avance Clinical, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Avance Clinical features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Avance Clinical public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Linear Clinical Research into a search box, you are probably building a CRO shortlist. This article uses only what Linear Clinical Research publishes (www.linear.org.au · linear.org.au/about-us · linear.org.au/partner-with-us) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Linear Clinical Research publishes

Linear Clinical Research is a not-for-profit early-phase organization in Perth, founded in 2010 by the Harry Perkins Institute of Medical Research with the WA Departments of Health and Commerce. It runs the Nedlands and Joondalup clinical trial centres and an Advanced Clinical Trial Centre, and says it has conducted more than 500 trials, including first-in-human, oncology and haematology studies. Its sponsor pages say 93% of its early-phase trials gained ethics approval in 4–6 weeks and 94.5% of its healthy-volunteer trials were dosed on time. We found no device study on its pages.

Linear Clinical Research vs bioaccess®

Dimension	Linear Clinical Research	bioaccess®
Core focus	Drug Phase I + first-in-patient oncology / haematology	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you are a drug or cell-therapy sponsor that wants a fast Australian Phase I, Linear is a strong option.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Linear Clinical Research, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Linear Clinical Research features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Linear Clinical Research public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed CMAX Clinical Research into a search box, you are probably building a CRO shortlist. This article uses only what CMAX Clinical Research publishes (www.cmax.com.au · www.cmax.com.au/about) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What CMAX Clinical Research publishes

CMAX Clinical Research is an Adelaide early-phase unit established in 1993 at 21–24 North Terrace in the BioMed precinct. It says it has experience in more than 800 early-phase trials, specializes in first-time-in-human studies, and lists work ranging from cancer treatments to early-warning bio-devices. In 2025 CMAX and its Fusion Clinical Research division were acquired by New Zealand Clinical Research, and the combined NZCR Group reports more than 150 trial beds across New Zealand and Australia. CMAX publishes as a success story the first-ever human trial of Nacuity's NPI-001, run by its PI in 2017.

CMAX Clinical Research vs bioaccess®

Dimension	CMAX Clinical Research	bioaccess®
Core focus	Drug Phase I–II unit with unit-compatible device work	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need first-in-human for a drug or a simple device that needs confinement in a Phase I unit, CMAX is a credible choice.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including CMAX Clinical Research, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not CMAX Clinical Research features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the CMAX Clinical Research public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.