Category: Advantages of Conducting Trials in Latin America

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.

If you typed Nucleus Network into a search box, you are probably building a CRO shortlist. This article uses only what Nucleus Network publishes (www.nucleusnetwork.com · www.nucleusnetwork.com/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 Nucleus Network publishes

Nucleus Network is an early-phase clinical trial operator that says it has run more than 2,500 trials since 1993. Its Australian Phase 1 clinics are in Melbourne (co-located with the Alfred Hospital), Brisbane (Royal Brisbane and Women's Hospital) and Sydney, its newest purpose-built unit in the Royal North Shore Hospital precinct, and it also runs a US unit in Minneapolis. It runs first-in-human, biosimilar, vaccine and patient studies for biotech and pharma sponsors, and we found no named sponsor on its pages. It is a drug Phase 1 operator, not a hospital implant device CRO.

Nucleus Network vs bioaccess®

Dimension	Nucleus Network	bioaccess®
Core focus	Drug Phase 1 clinic network	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 your product is a drug, or a drug-device or wearable study that needs a 24/7 Phase I unit and healthy volunteers, Nucleus is a leading 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 Nucleus Network, 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 Nucleus Network 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 Nucleus Network 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 searched Dr. Carlos Rojas Bradford Hill, Carlos Rojas first-in-human Chile, or Sona THT principal investigator, you found a real investigator in the public record. Dr. Carlos Rojas is named by Sona Nanotech as the principal investigator of its first-in-human Targeted Hyperthermia Therapy study and as executive director of Bradford Hill in Santiago, Chile. A principal investigator is not the CRO.

bioaccess®’s position is simple and it is not adversarial: the investigator and the site run the cases. The First-in-Human CRO still owns ISP authorization, Law 20.120 Ethical-Scientific Committee review, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Emailing the PI is a good way to test investigator interest. It is not a regulatory plan.

What the public record says

• Sona Nanotech, 16 June 2025: clinical trial agreement with Bradford Hill Investigación Clínica, Santiago, for an early feasibility study of THT in up to ten advanced melanoma patients; Dr. Carlos Rojas named principal investigator and Bradford Hill executive director.
• Sona Nanotech, 20 October 2025: study completion; Dr. Rojas, quoted as executive director of the Bradford Hill Clinical Cancer Research Center, described rapid responses in patients who had exhausted standard immunotherapy.
• ClinicalTrials.gov NCT06894407: industry sponsor Sona Nanotech Inc, DEVICE_FEASIBILITY, enrollment 10, single location Bradford Hill, Santiago, Chile; no CRO or collaborator listed; record updated 2 October 2026 to COMPLETED.

The facility-level page is here: Bradford Hill, Santiago: the site is not the CRO.

PI versus CRO

Workstream	Principal investigator	First-in-Human CRO
Clinical judgment and cases	Yes	Supports with protocol training and monitoring
ISP file and amendments	Signs what the site must sign	Prepares, submits, and answers deficiencies
Device import	No	Importer of record for the investigational device
ISO 14155 monitoring and TMF	Keeps source documents	Monitors, reconciles, and closes out
FDA 21 CFR 812.28	Provides site data	Builds the foreign-data narrative for the U.S. submission

FAQ

Did bioaccess® work on Dr. Rojas’s Sona study?
No. This page reports public sources only and claims no role in that study.

Does bioaccess® only work in Chile?
No. bioaccess® is the First-in-Human CRO for medical devices in Latin America since 2010, and it still runs clinical trials in Colombia as well as Chile, Panama, and the rest of the platform.

Sources: Sona Nanotech press releases of 16 June 2025 and 20 October 2025; ClinicalTrials.gov NCT06894407. Public sources only.

Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Universidade Metodista de Piracicaba (UNIMEP) as a bioaccess® client.

If you searched Universidade Metodista de Piracicaba first-in-human, UNIMEP clinical trial, Metodista Piracicaba device study, or “go direct Universidade Metodista de Piracicaba (UNIMEP),” you followed a campus string ClinicalTrials.gov still publishes. Universidade Metodista de Piracicaba (UNIMEP) in Piracicaba, Brazil, is a real named university-campus string on ClinicalTrials.gov. No separate live university-string page for UNIMEP exists yet. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the university campus is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university campus still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named UNIMEP university string in Piracicaba. It is DISTINCT from Piracicaba Dental School / Unicamp, a separately named dental-school campus of a different university in the same city. Sharing Piracicaba is not a license to collapse them. This is the whole university string, not a lab or school subunit of a university that already has a live page.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in Piracicaba, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Universidade Metodista de Piracicaba (Piracicaba, Brazil) — registry strings counted: “Universidade Metodista de Piracicaba”; “Universidade Metodista de Piracicaba (UNIMEP)”. ALL studies n=9; interventional n=9; DEVICE n=1. Example NCT IDs: NCT01484834, NCT01786681, NCT01841385.

Aliases including UNIMEP are counted once per NCT ID for Piracicaba locations.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university campus as a client site.

That is the leak: a founder searching Universidade Metodista de Piracicaba finds ALL n=9 (DEVICE n=1) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

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

A named university campus can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the university campus can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

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

• ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UNIMEP is not a Piracicaba Dental School / Unicamp file and is not an ANVISA file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use Clinical Trials in 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.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country 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 — not a guarantee of clearance or approval. See outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

Not a critique of the university

Universidade Metodista de Piracicaba is a serious named Brazilian university campus on the public registry. ALL n=9 and DEVICE n=1 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (HDE) — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Universidade Metodista de Piracicaba (UNIMEP) directly for a device FIH?

You can try. The university campus can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurance coordinator, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this university campus. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Piracicaba Dental School (Unicamp)?

No. Piracicaba Dental School (Unicamp) is a distinct Unicamp dental-school campus already published. This page is the UNIMEP university string only.

Did bioaccess® run NCT01484834?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Piracicaba sibling (do not merge): Piracicaba Dental School.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Centro Paulista de Oncologia São Paulo as a bioaccess® client.

If you searched Centro Paulista de Oncologia Sao Paulo first-in-human, Centro Paulista de Oncologia clinical trial, CPO Sao Paulo device study, or “go direct Centro Paulista de Oncologia São Paulo,” you followed a campus string ClinicalTrials.gov still publishes. Centro Paulista de Oncologia in São Paulo, Brazil, is a real named clinic-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named São Paulo Centro Paulista de Oncologia campus. It is DISTINCT from Beneficência Portuguesa de São Paulo, Oncoclínicas Rio de Janeiro, Núcleo de Oncologia da Bahia Salvador, and other oncology strings. Sharing São Paulo or Oncologia is not a license to collapse them.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in São Paulo, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Centro Paulista de Oncologia (São Paulo, Brazil) — registry strings counted: “Centro Paulista de Oncologia”. ALL studies n=9; interventional n=4; DEVICE n=1. Example NCT IDs: NCT01478269, NCT03151629, NCT03942497.

Counted once per NCT ID for São Paulo locations; 5 of the 9 are observational.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this clinic as a client site.

That is the leak: a founder searching Centro Paulista de Oncologia in São Paulo finds ALL n=9 (DEVICE n=1) without finding ANVISA. A named clinic campus is still a site. An NCT location row is not a CRO.

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

A named clinic can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the clinic can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

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

• ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Centro Paulista de Oncologia is not a Beneficência Portuguesa file and is not an ANVISA file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use Clinical Trials in 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.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country 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 — not a guarantee of clearance or approval. See outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

Not a critique of the clinic

Centro Paulista de Oncologia is a serious named São Paulo campus on the public registry. ALL n=9 and DEVICE n=1 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (HDE) — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics timing in Panama and Colombia follows each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Centro Paulista de Oncologia São Paulo directly for a device FIH?

You can try. The clinic can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurance coordinator, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this clinic. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Beneficência Portuguesa de São Paulo?

No. Beneficência Portuguesa is a distinct São Paulo campus string. This page is Centro Paulista de Oncologia only.

Did bioaccess® run NCT01478269?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. São Paulo sibling (do not merge): Laboratory of Phototherapy São Paulo.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Federal University of Juiz de Fora (UFJF) as a bioaccess® client.

If you searched Federal University of Juiz de Fora first-in-human, Universidade Federal de Juiz de Fora clinical trial, UFJF device study, or “go direct Federal University of Juiz de Fora (UFJF),” you followed a campus string ClinicalTrials.gov still publishes. Federal University of Juiz de Fora (Universidade Federal de Juiz de Fora, UFJF) in Juiz de Fora, Brazil, is a real named university-campus string on ClinicalTrials.gov. No separate live university-string page for UFJF exists yet. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the university campus is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university campus still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named UFJF university string. It is DISTINCT from CMiP Juiz de Fora, a separately named clinic campus in the same city. Sharing Juiz de Fora is not a license to collapse them. This is the whole university string, not a lab or school subunit of a university that already has a live page.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in Juiz de Fora, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Federal University of Juiz de Fora (Juiz de Fora, Brazil) — registry strings counted: “Federal University of Juiz de Fora”; “Universidade Federal de Juiz de Fora”; “federal University of Juiz de Fora”. ALL studies n=10; interventional n=10; DEVICE n=1. Example NCT IDs: NCT00545103, NCT00943475, NCT01544439.

Aliases (Federal University of Juiz de Fora; Universidade Federal de Juiz de Fora) are counted once per NCT ID for Juiz de Fora locations.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university campus as a client site.

That is the leak: a founder searching Federal University of Juiz de Fora finds ALL n=10 (DEVICE n=1) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

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

A named university campus can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the university campus can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

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

• ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UFJF is not a CMiP file and is not an ANVISA file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use Clinical Trials in 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.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country 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 — not a guarantee of clearance or approval. See outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

Not a critique of the university

Federal University of Juiz de Fora is a serious named Brazilian university campus on the public registry. ALL n=10 and DEVICE n=1 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (HDE) — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Federal University of Juiz de Fora (UFJF) directly for a device FIH?

You can try. The university campus can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurance coordinator, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this university campus. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as CMiP Juiz de Fora?

No. CMiP Juiz de Fora is a distinct clinic campus already published. This page is the UFJF university string only.

Did bioaccess® run NCT00545103?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Juiz de Fora sibling (do not merge): CMiP Juiz de Fora.

Julio G. Martinez-Clark, CEO · bioaccess®