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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.

  • New Zealand vs Latin America for First-in-Human Device Trials (2026)

    New Zealand is one of the quickest places in the world to start a first-in-human device study. Medsafe doesn’t approve device trials, one national ethics committee covers every site, and no FDA IDE is needed to begin. What New Zealand can’t change is its size: about 5.36 million people. If your protocol needs more patients, more diversity or a backup country, Latin America is where bioaccess® has run device first-in-human studies since 2010.

    Why sponsors choose New Zealand

    These are the real reasons, and each one has an official source.

    • No regulatory approval for device trials. Medsafe says there is “no provision under the current legislation (the Medicines Act 1981) to require approval of clinical trials of medical devices”. It asks to be told by email, and that notice “does not constitute an approval” (Medsafe Clinical Trials Guideline, §7; Medsafe device trials page). Investigational devices brought in for a trial don’t need WAND notification.
    • One ethics review for all sites. A single Health and Disability Ethics Committee (HDEC) review covers every site. Each site still needs locality authorisation (Callaghan Innovation HealthTech Activator).
    • Published ethics clocks. HDEC aims to decide expedited applications within 15 calendar days and full reviews within 35 (HDEC).
    • No IDE to start. The government’s own guidance notes that New Zealand’s process “does not currently require U.S FDA Investigational Device Exemption (IDE) filing prior to the start of the study” (Callaghan).
    • English and GCP. Trials are expected to follow ICH E6(R3), and Medsafe points device sponsors to ISO 14155.
    • Tax incentives, with limits. New Zealand’s R&D Tax Incentive is a 15% credit for eligible R&D by NZ taxpayers, and overseas spend is capped (Inland Revenue). Australian companies can claim New Zealand trial costs under Australia’s R&D Tax Incentive, but only with an approved Overseas Finding (business.gov.au).

    What to plan for in New Zealand

    • Patient volume. Stats NZ estimates 5,357,300 residents (30 June 2026) (Stats NZ). For a rare anatomy or a narrow inclusion window, the pool of candidates is limited.
    • Real-world ethics timing. HDEC’s Secretariat warns that full applications can take another 2–4 weeks to get onto an agenda, that it caps each meeting at 8–10 applications, and that decision letters can take up to 4 weeks after the meeting. For expedited review, plan on the full 15-day clock (HDEC update).
    • Injury compensation is the sponsor’s job. New Zealand’s ACC scheme doesn’t cover trials run “principally for the benefit of the manufacturer” (Accident Compensation Act s32). Commercial sponsors must offer ACC-equivalent compensation, including earnings-related compensation, for the whole trial (NEAC Standard 17).
    • Site governance. Health New Zealand sites run their own research-office review, which includes a Māori responsiveness assessment and scientific peer review (Callaghan).
    • The rules are changing. A Ministry of Health briefing calls New Zealand’s lack of device pre-market approval an international outlier. The planned Medical Products Bill is expected to be introduced in 2027, with commencement expected around 2029–2030 (MoH briefing, June 2026; DHA, May 2026).

    What the registry data shows

    We pulled ClinicalTrials.gov on 28 October 2026. Of 216 closed interventional device studies with a New Zealand site, 11.1% were terminated or withdrawn, compared with 22.7% for the United States and 13.2% for Australia. Only 6 of the 216 named slow or low recruitment as the reason, and most of those ran in New Zealand only. Starting is rarely the problem in New Zealand; enrolling enough patients can be. (Method: CT.gov API v2, interventional, intervention type = device, ≥1 site in the country. Many ANZ studies register only on ANZCTR.)

    New Zealand vs Latin America at a glance

    New Zealand Latin America with bioaccess®
    Device trial regulator No Medsafe approval; email notification only Varies by country. Some add a regulator review (e.g., Argentina’s ANMAT under Disposition 969/1997, up to 90 business days)
    Ethics One national HDEC review; 15 or 35 calendar-day targets Site or national committees; timing set by each committee’s meeting schedule
    Patient pool 5.36M nationally Several countries’ catchments can run under one plan
    Time zone vs U.S. UTC+12 (+13 in NZ daylight time) Same or near U.S. time zones
    Injury cover Sponsor provides ACC-equivalent compensation Sponsor clinical-trial insurance per country rules
    FDA use of data Eligible under 21 CFR 812.28 if GCP, ethics and consent are met Same standard (21 CFR 812.28)
    After the trial Device market currently has no pre-market approval bioaccess® offers in-country registration and holder service (market access)

    Which fits your study

    • Choose New Zealand if you need a few implants fast, your investigators are already there, and your enrollment target fits a 5-million-person country.
    • Add Latin America if you need more patients, a second country to protect timelines, U.S.-adjacent time zones for your clinical team, or a route from first-in-human data to market access in the region.
    • Run both if speed of first implant and enrollment certainty both matter. Being eligible under 812.28 is not the same as clearance; FDA decides case by case.

    New Zealand CRO and site comparisons

    Frequently asked questions

    Does New Zealand require Medsafe approval for a medical device clinical trial?

    No. Under the Medicines Act 1981 there is no provision to require approval of device trials. Medsafe asks to be notified by email, and notification is not approval. HDEC ethics approval is still required.

    How long does HDEC ethics approval take?

    HDEC aims to decide expedited applications within 15 calendar days and full reviews within 35. The clock can pause once for up to 90 days. Its November 2024 update adds agenda and letter delays for full reviews.

    Do I need an FDA IDE to run a first-in-human device study in New Zealand?

    Not to start in New Zealand. If the data will support a U.S. submission, it must meet 21 CFR 812.28 (GCP, ethics review, informed consent, and FDA’s ability to validate the data).

    Does ACC cover injuries in a sponsored device trial?

    No, not for trials run principally for the manufacturer’s benefit. The sponsor must provide ACC-equivalent compensation, usually through no-fault clinical trial insurance accepted by HDEC.

    Can a U.S. startup claim New Zealand’s 15% R&D Tax Incentive?

    The incentive is for eligible R&D by entities taxed in New Zealand, and overseas spend is capped. Check eligibility with Inland Revenue before you count it in your budget.

    Why would a sponsor add Latin America after New Zealand?

    Mainly patient volume and backup capacity. Same- or near-U.S. time zones and a path to regional registration also help. bioaccess® has run device first-in-human and early feasibility studies in Latin America since 2010.

    Request a first-in-human study proposal · bioaccess® vs New Zealand · bioaccess® vs Australia

    Sources accessed 28 October 2026. No sponsor, prices or timelines are invented. Competitor and country claims are attributed to their publishers.

  • Soluciones Integrales para Investigación Clínica vs a First-in-Human Device CRO (bioaccess®)

    If you typed Soluciones Integrales para Investigación Clínica into a search box, you are probably building a CRO or site shortlist for Paraguay. This article uses only what is public about Soluciones Integrales para Investigación Clínica (www.sitioresearch.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 Soluciones Integrales para Investigación Clínica publishes

    Soluciones Integrales para Investigación Clínica en Paraguay describes itself on its site as a pioneering organization specializing in clinical research in Paraguay, with knowledge of the country’s regulatory, medical and operational environment.

    Soluciones Integrales para Investigación Clínica vs bioaccess®

    Dimension Soluciones Integrales para Investigación Clínica bioaccess®
    Core focus Clinical research support, Paraguay First-in-human and early feasibility studies for medical devices
    Geography See provider site 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 local clinical research support in Paraguay, Soluciones Integrales’ 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 Soluciones Integrales para Investigación 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.

    For the local regulatory path, see CRO in Paraguay. 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 Soluciones Integrales para Investigación Clínica public pages and registries linked above, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Research & Data Processing (RDP) vs a First-in-Human Device CRO (bioaccess®)

    If you typed Research & Data Processing (RDP) into a search box, you are probably building a CRO or site shortlist for Venezuela. This article uses only what is public about Research & Data Processing (RDP LinkedIn) 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 Research & Data Processing publishes

    Research & Data Processing, C.A. (RDP) is a Caracas-based company providing clinical data management, CDISC-SDTM data tabulation and biostatistics for clinical trials. It has announced CDISC Gold Membership.

    Research & Data Processing vs bioaccess®

    Dimension Research & Data Processing bioaccess®
    Core focus Clinical data management and biostatistics First-in-human and early feasibility studies for medical devices
    Geography See provider site 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 clinical data management or CDISC-SDTM conversion, RDP’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 Research & Data Processing, 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 local regulatory path, see CRO in Venezuela. 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 Research & Data Processing public pages and registries linked above, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Registrum Group vs a First-in-Human Device CRO (bioaccess®)

    If you typed Registrum Group into a search box, you are probably building a CRO or site shortlist for Dominican Republic. This article uses only what is public about Registrum Group (registrumgroup.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 Registrum Group publishes

    Registrum Group describes itself as a Dominican site management organization that conducts clinical trials, selects investigators and sites, reviews protocols, plans recruitment and offers regulatory services and clinical research advice in the Dominican Republic.

    Registrum Group vs bioaccess®

    Dimension Registrum Group bioaccess®
    Core focus SMO and regulatory services, Dominican Republic First-in-human and early feasibility studies for medical devices
    Geography See provider site 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 site management and regulatory support in the Dominican Republic, Registrum’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 Registrum Group, 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 local regulatory path, see CRO in Dominican Republic. 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 Registrum Group public pages and registries linked above, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

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

    If you typed Accuracy Research into a search box, you are probably building a CRO or site shortlist for Ecuador. This article uses only what is public about Accuracy Research (www.accuracyresearch.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 Accuracy Research publishes

    Accuracy Research presents itself as a CRO company in Latin America based in Quito, Ecuador. Its site covers clinical trials, decentralized trials, pharmacovigilance, regulatory affairs and quality topics.

    Accuracy Research vs bioaccess®

    Dimension Accuracy Research bioaccess®
    Core focus Drug CRO, Ecuador First-in-human and early feasibility studies for medical devices
    Geography See provider site 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 Ecuador-based CRO for drug or vaccine trials, Accuracy Research’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 Accuracy 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.

    For the local regulatory path, see CRO in Ecuador. 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 Accuracy Research public pages and registries linked above, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

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

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

    STEER Centro de Administración y Asesoría en Investigación Clínica Cía. Ltda. is a Quito-based company listed in the national register of contract research organizations kept by Ecuador’s regulator ARCSA.

    STEER vs bioaccess®

    Dimension STEER bioaccess®
    Core focus Clinical research administration, Ecuador First-in-human and early feasibility studies for medical devices
    Geography See provider site 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 ARCSA-registered local organization for clinical research administration in Ecuador, STEER’s 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 STEER, 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 local regulatory path, see CRO in Ecuador. 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 STEER public pages and registries linked above, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • TRIAL (Therapeutic Research Institute and Lab) vs a First-in-Human Device CRO (bioaccess®)

    If you typed TRIAL (Therapeutic Research Institute and Lab) into a search box, you are probably building a CRO or site shortlist for Guatemala. This article uses only what is public about TRIAL (trialresearch.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 TRIAL publishes

    TRIAL describes itself as a CRO and site management organization (SMO) in Guatemala, offering regulatory services, investigational product management including storage and distribution, research site support and continuing education.

    TRIAL vs bioaccess®

    Dimension TRIAL bioaccess®
    Core focus CRO/SMO, regulatory and logistics, Guatemala First-in-human and early feasibility studies for medical devices
    Geography See provider site 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 Guatemala-based CRO/SMO for regulatory, logistics and site support, TRIAL’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 TRIAL, 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 local regulatory path, see CRO in Guatemala. 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 TRIAL public pages and registries linked above, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • ICIC (Instituto Costarricense de Investigaciones Clínicas) vs a First-in-Human Device CRO (bioaccess®)

    If you typed ICIC (Instituto Costarricense de Investigaciones Clínicas) into a search box, you are probably building a CRO or site shortlist for Costa Rica. This article uses only what is public about ICIC (ClinicalTrials.gov NCT04497610) 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 ICIC publishes

    The Instituto Costarricense de Investigaciones Clínicas (ICIC) is a clinical research institution in San José, Costa Rica. It is the lead sponsor on ClinicalTrials.gov of a study of a breath-analyzer system for SARS-CoV-2 detection (NCT04497610).

    ICIC vs bioaccess®

    Dimension ICIC bioaccess®
    Core focus Clinical research institution, Costa Rica First-in-human and early feasibility studies for medical devices
    Geography See provider site 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 clinical research institution in Costa Rica, ICIC’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 ICIC, 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 local regulatory path, see CRO in Costa Rica. 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 ICIC public pages and registries linked above, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

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

    If you typed QPharma Research into a search box, you are probably building a CRO or site shortlist for Dominican Republic. This article uses only what is public about QPharma Research (qpharmaresearch.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 QPharma Research publishes

    QPharma Research describes itself as a Caribbean research partner based in the Dominican Republic, focused on delivering human biospecimens (tissue, FFPE, blood and other samples) with clinical data for research, through prospective and archived collections.

    QPharma Research vs bioaccess®

    Dimension QPharma Research bioaccess®
    Core focus Biospecimens and research support, Caribbean First-in-human and early feasibility studies for medical devices
    Geography See provider site 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 human biospecimens or research support in the Caribbean, QPharma’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 QPharma 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.

    For the local regulatory path, see CRO in Dominican Republic. 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 QPharma Research public pages and registries linked above, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • VaxTrials (now Emmes) vs a First-in-Human Device CRO (bioaccess®)

    If you typed VaxTrials (now Emmes) into a search box, you are probably building a CRO or site shortlist for Panama. This article uses only what is public about VaxTrials (Emmes announcement) 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 VaxTrials publishes

    VaxTRIALS was a Panama City-based CRO specializing in vaccine trials in Latin America and the Philippines; Emmes announced its acquisition in 2023. Vaxtrials S.A. appears on ClinicalTrials.gov as sponsor or collaborator on polio vaccine studies supported by the Gates Foundation (e.g. NCT02111135).

    VaxTrials vs bioaccess®

    Dimension VaxTrials bioaccess®
    Core focus Vaccine and infectious-disease trials (part of Emmes) First-in-human and early feasibility studies for medical devices
    Geography See provider site 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 vaccine or infectious-disease trial capacity in Latin America, Emmes/VaxTRIALS’ 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 VaxTrials, 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 local regulatory path, see CRO in Panama. 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 VaxTrials public pages and registries linked above, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.