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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.

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

    If you typed ACLIRES into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about ACLIRES (LinkedIn company page) 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 ACLIRES publishes

    ACLIRES-PERU S.A.C. is the Peruvian entity linked to Aclires International, a boutique CRO whose public company profile describes drug clinical research services, including infectious disease. ACLIRES-PERU appears as ROIC-232 in the INS register of research organizations (OIC).

    ACLIRES vs bioaccess®

    Dimension ACLIRES bioaccess®
    Core focus Boutique drug CRO (Peru entity of Aclires International) First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) 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 boutique drug CRO with a Peru registration, ACLIRES’ published profile matches.

    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 or site on your list, including ACLIRES, 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.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS 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.

    Facts from the ACLIRES public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

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

    If you typed Genexion into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Genexion (INS register of research organizations (OIC)) 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 Genexion publishes

    Genexion S.A.C. (Genexion Perú) is a Lima-based (Miraflores) research organization registered in the INS register of research organizations (OIC) (ROIC-200/315). We did not find a current company website. Public INS trial listings associate it with Phase III drug research.

    Genexion vs bioaccess®

    Dimension Genexion bioaccess®
    Core focus Peru drug research organization (INS-registered) First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) 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 an INS-registered local organization for a Phase III drug study in Peru, Genexion’s public registration matches.

    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 or site on your list, including Genexion, 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.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS 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.

    Facts from the Genexion public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

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

    If you typed Impacta into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Impacta (impactaperu.org) 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 Impacta publishes

    Asociación Civil Impacta Salud y Educación is a Lima non-profit whose website centers on HIV research, education and community programs, and an institutional bioethics committee. It appears as ROIC-77 in the INS register of research organizations (OIC), and it is listed as a study site on ClinicalTrials.gov records for HIV prevention research with academic partners.

    Impacta vs bioaccess®

    Dimension Impacta bioaccess®
    Core focus Non-profit HIV prevention research site First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) 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 Lima site with long experience in HIV prevention research, Impacta’s public record matches.

    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 or site on your list, including Impacta, 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.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS 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.

    Facts from the Impacta public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

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

    If you typed Vía Libre into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Vía Libre (vialibre.org.pe) 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 Vía Libre publishes

    Asociación Vía Libre is a Lima non-profit focused on HIV. Its website describes a specialized health center, clinical laboratory, pharmacy, research activity and an institutional bioethics committee. It appears as ROIC-367 in the INS register of research organizations (OIC), and it is listed on ClinicalTrials.gov records for HIV research with academic partners.

    Vía Libre vs bioaccess®

    Dimension Vía Libre bioaccess®
    Core focus HIV NGO, research site and ethics committee First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) 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 Lima research site or ethics review for HIV-related studies, Vía Libre’s public record matches.

    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 or site on your list, including Vía Libre, 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.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS 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.

    Facts from the Vía Libre public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

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

    If you typed Científica CRO into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Científica CRO (cientificacro.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 Científica CRO publishes

    Científica CRO SAC is a Lima-based (Pueblo Libre) CRO. Its website lists protocol and essential-document writing, feasibility and project management, clinical monitoring, regulatory affairs, active and passive pharmacovigilance, quality management, data management and statistics, systematic reviews, scientific writing, training and translations. It appears as ROIC-337 in the INS register of research organizations (OIC).

    Científica CRO vs bioaccess®

    Dimension Científica CRO bioaccess®
    Core focus Peru monitoring, regulatory, PV, medical writing First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) 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 Peru-based monitoring, regulatory, pharmacovigilance or writing support, Científica CRO’s published 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 or site on your list, including Científica 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.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS 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.

    Facts from the Científica CRO public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

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

    If you typed Latamciencias into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Latamciencias (LinkedIn company page) 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 Latamciencias publishes

    Latinoamericana de Ciencias SAC (Latamciencias) is a Lima-based CRO. Its public company profile describes clinical monitoring, pharmacovigilance and regulatory affairs services. It appears as ROIC-289 in the INS register of research organizations (OIC).

    Latamciencias vs bioaccess®

    Dimension Latamciencias bioaccess®
    Core focus Peru monitoring, PV, regulatory First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) 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 Peru-based monitoring, pharmacovigilance or regulatory support, Latamciencias’ published 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 or site on your list, including Latamciencias, 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.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS 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.

    Facts from the Latamciencias public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

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

    If you typed INMENSA into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about INMENSA (ClinicalTrials.gov) 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 INMENSA publishes

    INMENSA (Investigaciones Médicas en Salud) is a non-profit research organization in Lince, Lima, focused on HIV and infectious-disease research. It appears as ROIC-166 in the INS register of research organizations (OIC), and it is listed as a study facility on ClinicalTrials.gov records that include ACTG network and industry-sponsored infectious-disease trials.

    INMENSA vs bioaccess®

    Dimension INMENSA bioaccess®
    Core focus Non-profit HIV and infectious-disease research site First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) 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 an experienced research site for HIV or infectious-disease trials in Lima, INMENSA’s public record matches.

    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 or site on your list, including INMENSA, 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.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS 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.

    Facts from the INMENSA public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Peruvian Clinical Research (PCR) Peru vs a First-in-Human Device CRO (bioaccess®)

    If you typed Peruvian Clinical Research (PCR) into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Peruvian Clinical Research (PCR) (pcr.pe) 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 Peruvian Clinical Research (PCR) publishes

    Peruvian Clinical Research describes itself on its Spanish-language site as a Peruvian company offering clinical research, a licensed drug warehouse (droguería), regulatory consulting and pharmacovigilance. It appears as registered research organization ROIC-117 in the INS register of research organizations (OIC). On ClinicalTrials.gov it is listed as sponsor or collaborator on studies that include a transcranial laser device study in major depressive disorder (NCT05435820, NCT06934135) and a CDC-led influenza vaccine study (NCT06054269).

    Peruvian Clinical Research (PCR) vs bioaccess®

    Dimension Peruvian Clinical Research (PCR) bioaccess®
    Core focus Peru clinical operations, droguería (importer/warehouse), PV and regulatory First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) 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 Peru-based team that combines study operations with local import and warehousing of investigational product, PCR’s published 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 or site on your list, including Peruvian Clinical Research (PCR), 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.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS 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.

    Facts from the Peruvian Clinical Research (PCR) public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

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

    If you typed Gotuzzo Asociados into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Gotuzzo Asociados (LinkedIn company page) 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 Gotuzzo Asociados publishes

    Gotuzzo Asociados S.A.C. is a Lima-based (Miraflores) clinical research services firm. Its public company profile describes services such as acting as legal representative before Peru’s INS, regulatory affairs, monitoring, investigational product import and translation. It appears as ROIC-96 in the INS register of research organizations (OIC).

    Gotuzzo Asociados vs bioaccess®

    Dimension Gotuzzo Asociados bioaccess®
    Core focus Peru legal representation, regulatory, monitoring First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) 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 an INS legal representative and local regulatory and monitoring support for a drug study in Peru, Gotuzzo Asociados’ published 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 or site on your list, including Gotuzzo Asociados, 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.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS 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.

    Facts from the Gotuzzo Asociados public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Your Australian First-in-Human Trial Is Enrolling Slowly: Adding a Latin American Cohort

    General information, not legal or regulatory advice. Sources checked on 25 October 2026. bioaccess® is not affiliated with any company named on this page, and describes other companies only by what they publish themselves.

    Signs you are behind

    • The registered primary completion date has passed and the study still shows recruiting.
    • Sites have been added mid-study.
    • Screen-failure rates are higher than the protocol assumed.

    For the underlying math, see catchment math for Australian recruitment.

    A same-protocol second country

    See adding a Latin American country to an Australia-only NCT, and our bioaccess® vs Australia comparison for the R&D tax incentive question.

    Standards and U.S. data acceptance

    The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study follows good clinical practice (GCP), has independent ethics review and informed consent, and FDA can validate the data. The rule is the same whether the sites are in Central Asia, the Caucasus or Latin America.

    How Latin America compares

    • Same FDA rule: 21 CFR 812.28.
    • Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination; our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
    • Time zone: 0–2 hours from U.S. Eastern.
    • U.S. continuity: bioaccess® is headquartered in Miami; its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
    • Trade-offs: Spanish or Portuguese documents and investigational import permits.

    More: FIH in Chile · FIH in El Salvador · Uzbekistan · Kazakhstan · Vantage Clinical comparison

    Frequently asked questions

    Can I add a Latin American country to an Australian FIH?

    Yes, a second country can run under the same protocol with its own ethics and regulatory approvals.

    Will FDA accept the combined data?

    Foreign data can support FDA submissions under 21 CFR 812.28, case by case.

    Next step

    Weighing Central Asia or the Caucasus against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®, or come on the Global Trial Accelerator podcast to talk through your FIH plan.