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Category: Preparing for First-In-Human Studies

Offers insights and best practices for Medtech, Biopharma, and Radiopharma companies preparing for their first-in-human clinical trials.

  • Nucleus Network Phase I vs a Latin America First-in-Human Device CRO (bioaccess®)

    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.

  • Salud Solutions LATAM FSP vs a First-in-Human Device CRO (bioaccess®)

    If you typed Salud Solutions into a search box, you are probably building a CRO shortlist. This article uses only what Salud Solutions publishes (salud-solutions.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 Salud Solutions publishes

    Salud Solutions is a family-owned Buenos Aires boutique CRO dedicated to Latin America since 1999. It specializes in Phase IV, observational and real-world evidence studies, plus functional-service (FSP) support. It has local CRAs in Argentina, Peru and Brazil, with additional coverage in Chile, Ecuador, Colombia, Mexico, and Central America and the Caribbean, and it handles import licenses for investigational product, kits and equipment, with local representation when the sponsor has no entity in the country. It says eight of its last fourteen studies were Phase IV, focused on oncology and respiratory. We found no device page on its site.

    Salud Solutions vs bioaccess®

    Dimension Salud Solutions bioaccess®
    Core focus LATAM late-phase / real-world evidence boutique CRO and FSP First-in-human and early feasibility studies for medical devices
    Geography Local CRAs in Argentina, Peru and Brazil; coverage in Chile, Ecuador, Colombia, Mexico, Central America and the Caribbean 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-authorization studies, patient registries and real-world evidence Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need a late-phase, observational or real-world study in South America, or extra monitoring capacity on a regional study, Salud Solutions 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 Salud Solutions, 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.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

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

    Competitor facts from the Salud Solutions 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.

  • Sayani Peru CRO vs a First-in-Human Device CRO (bioaccess®)

    If you typed Sayani Latin America CRO into a search box, you are probably building a CRO shortlist. This article uses only what Sayani Latin America CRO publishes (sayanibpo.com/es/inicio) 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 Sayani Latin America CRO publishes

    Sayani is a small Lima-based CRO whose Spanish homepage refers to the development of medicines and medical devices. Its services are Phase II–IV operations, medical writing, pharmacovigilance and late-phase / real-world evidence.

    Sayani Latin America CRO vs bioaccess®

    Dimension Sayani Latin America CRO bioaccess®
    Core focus Peru late-phase ops, medical writing, PV First-in-human and early feasibility studies for medical devices
    Geography Lima, Peru; says it has local and regional presence in Latin America 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 Pharmacovigilance listed Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need Peruvian late-phase operations, pharmacovigilance or medical writing, Sayani's services match.

    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 Sayani Latin America 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.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

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

    Competitor facts from the Sayani Latin America 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.

  • CIDEPRO Colombia Preclinical and Clinical CRO vs bioaccess®

    If you typed CIDEPRO into a search box, you are probably building a CRO shortlist. This article uses only what CIDEPRO publishes (cideprocolombia.org/cidepro) 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 CIDEPRO publishes

    CIDEPRO is a Colombian organization offering preclinical and clinical research services to the pharmaceutical, biotechnology and medical device industries, with a tilt toward tropical and public-health product development. We found no named device study on its site.

    CIDEPRO vs bioaccess®

    Dimension CIDEPRO bioaccess®
    Core focus Colombia preclinical + clinical services First-in-human and early feasibility studies for medical devices
    Geography Medellín, Colombia 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 consulting and product development listed Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need preclinical work in Colombia, or a public-health product program, CIDEPRO's mix is the right shape.

    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 CIDEPRO, 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.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

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

    Competitor facts from the CIDEPRO 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.

  • ZEED Pharmaceutical Solutions Mexico vs a First-in-Human Device CRO (bioaccess®)

    If you typed ZEED Pharmaceutical Solutions into a search box, you are probably building a CRO shortlist. This article uses only what ZEED Pharmaceutical Solutions publishes (zeed.com.mx) 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 ZEED Pharmaceutical Solutions publishes

    ZEED Pharmaceutical Solutions is a Mexico City firm that plans and follows clinical research for new pharmaceutical products and medical devices. It emphasizes NOM-012, COFEPRIS and independent monitoring, and advertises Phase I PK, bioavailability and bioequivalence studies.

    ZEED Pharmaceutical Solutions vs bioaccess®

    Dimension ZEED Pharmaceutical Solutions bioaccess®
    Core focus Mexico BE / PK and independent monitoring First-in-human and early feasibility studies for medical devices
    Geography Mexico (Mexico City) 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 Intensive pharmacovigilance (farmacovigilancia intensiva) listed Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If the need is independent monitoring or a bioequivalence package for COFEPRIS, ZEED 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 ZEED Pharmaceutical Solutions, 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.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

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

    Competitor facts from the ZEED Pharmaceutical Solutions 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.

  • Avant Santé Monterrey vs a First-in-Human Device CRO (bioaccess®)

    If you typed Avant Santé Research Center into a search box, you are probably building a CRO shortlist. This article uses only what Avant Santé Research Center publishes (www.avantsante.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 Avant Santé Research Center publishes

    Avant Santé Research Center is based in San Pedro Garza García, Monterrey. It runs a Phase I unit for new chemical entities and BA/BE studies and promotes drug and device development on LinkedIn. Dr. Sitaramaraju Yarramraju is founder and CEO. Its device experience is less documented than its early-phase drug work.

    Avant Santé Research Center vs bioaccess®

    Dimension Avant Santé Research Center bioaccess®
    Core focus Mexico Phase I / BA-BE unit, drug-primary First-in-human and early feasibility studies for medical devices
    Geography Monterrey HQ; operations in Latin America and the USA 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 consulting and pharmacovigilance listed Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need a Mexican Phase I or bioequivalence unit for a drug, Avant Santé is a fit.

    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 Avant Santé Research Center, 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.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

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

    Competitor facts from the Avant Santé Research Center 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.

  • EPIC Research CRO Mexico vs a First-in-Human Device CRO (bioaccess®)

    If you typed EPIC Research CRO into a search box, you are probably building a CRO shortlist. This article uses only what EPIC Research CRO publishes (epic-cro.com · epic-cro.com/who_we_are.html) 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 EPIC Research CRO publishes

    EPIC Research CRO is based in Coyoacán, Mexico City. Its who-we-are page describes full-range clinical development, regulatory and post-approval services for the pharmaceutical, biotech, medical device and nutraceutical industries in Latin America. Annette G. Ortiz Austin is Director General.

    EPIC Research CRO vs bioaccess®

    Dimension EPIC Research CRO bioaccess®
    Core focus Mexico full-range CRO across product classes First-in-human and early feasibility studies for medical devices
    Geography Mexico City; Latin America 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-approval services, per its who-we-are page Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need Mexican clinical development plus post-approval support under one roof, EPIC publishes that menu.

    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 EPIC Research 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.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

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

    Competitor facts from the EPIC Research 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.

  • CREOS CRO Argentina vs a First-in-Human Device CRO (bioaccess®)

    If you typed CREOS into a search box, you are probably building a CRO shortlist. This article uses only what CREOS publishes (www.creoscro.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 CREOS publishes

    CREOS is a Buenos Aires CRO offering "solutions in clinical research to the pharmaceutical, biotechnology and medical devices industry": Phase I–III, bioequivalence, adaptive, basket and umbrella designs, and real-world evidence. Its co-founders are Daniel Livio, MD, and Néstor Flaster, MD, a former ANMAT evaluator.

    CREOS vs bioaccess®

    Dimension CREOS bioaccess®
    Core focus Argentine drug / RWE CRO with devices listed First-in-human and early feasibility studies for medical devices
    Geography Buenos Aires HQ; works across Latin America with local experts in each country 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 / real-world studies and a full pharmacovigilance service, including post-marketing Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If the study is an Argentine Phase II–III, a bioequivalence study or a real-world evidence project, CREOS fits the brief.

    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 CREOS, 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.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

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

    Competitor facts from the CREOS 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.

  • Avanti Pesquisa Clínica Brazil vs a First-in-Human Device CRO (bioaccess®)

    If you typed Avanti Pesquisa Clínica into a search box, you are probably building a CRO shortlist. This article uses only what Avanti Pesquisa Clínica publishes (avantipc.com.br/en) 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 Avanti Pesquisa Clínica publishes

    Avanti Pesquisa Clínica is a São Paulo ARO/CRO that serves pharmaceutical, biotechnology, biosimilar and medical device companies across Phases I–IV, with clinical supplies and device storage among its services. We found no named device study on its site.

    Avanti Pesquisa Clínica vs bioaccess®

    Dimension Avanti Pesquisa Clínica bioaccess®
    Core focus Brazil ARO/CRO + clinical supplies First-in-human and early feasibility studies for medical devices
    Geography Brazil (São Paulo); describes itself as a Latin American ARO 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 a Brazilian partner for study execution plus clinical-supply logistics, Avanti covers both.

    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 Avanti Pesquisa Clínica, 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.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

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

    Competitor facts from the Avanti Pesquisa Clínica 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.

  • Azidus / AZD CRO Brazil vs a First-in-Human Device CRO (bioaccess®)

    If you typed Azidus (AZD CRO) into a search box, you are probably building a CRO shortlist. This article uses only what Azidus (AZD CRO) publishes (azidusbrasil.com.br) 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 Azidus (AZD CRO) publishes

    Azidus Brasil (AZD CRO) is based in Valinhos, São Paulo state, and cites 25 years of experience, with partnerships it lists in Argentina, Colombia, Uruguay, Mexico, Canada and the US. It offers First in Human, proof-of-concept and Phase I work, and its solutions cover health products alongside synthetics, biologics, cell therapy, vaccines, cosmetics and food. Dra. Luciana Ferrara is CEO. Its client list is mostly pharma.

    Azidus (AZD CRO) vs bioaccess®

    Dimension Azidus (AZD CRO) bioaccess®
    Core focus Brazil early-phase CRO, drug and health products First-in-human and early feasibility studies for medical devices
    Geography Brazil (Valinhos, SP); partnerships in Argentina, Colombia, Uruguay, Mexico, Canada and the US 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 Product registration support (its homepage pairs clinical studies with product registration) Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need Brazilian Phase I or proof-of-concept for a drug, biologic or cosmetic, Azidus 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 Azidus (AZD 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.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

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

    Competitor facts from the Azidus (AZD 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.