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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.

  • Israeli Medtech First-in-Human Studies Abroad: Caucasus, Central Asia or Latin America

    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.

    What the registry shows

    • Magenta Medical: NCT07293923 lists sites in Georgia and Israel.
    • Endomatic: NCT06099106 lists a site in Tashkent, Uzbekistan.
    • ENTire Medical: NCT06438185 lists sites in Uzbekistan and Israel.
    • Sanoculis: studies such as NCT05638321 list a site in Armenia.
    • Precise Bio: NCT07325097 lists sites in Armenia and Israel.

    We describe these studies only by their public registry entries and draw no conclusion about any company’s choices.

    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

    Where do Israeli device companies run FIH studies abroad?

    Public ClinicalTrials.gov records show Israeli sponsors with sites in Georgia, Uzbekistan and Armenia, among others.

    Can Latin American FIH data support FDA submissions?

    Yes, under 21 CFR 812.28, if GCP is followed and FDA can validate the data.

    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.

  • First-in-Human Trials in Central Asia, and When Latin America Is the Faster Second Geography

    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.

    U.S. and Israeli device companies are running first-in-human (FIH) studies in Uzbekistan and Kazakhstan. This page sums up what the public registry shows country by country.

    Country snapshot (ClinicalTrials.gov)

    Industry-sponsored studies with a site in each country and a start date in 2021 or later (ClinicalTrials.gov API v2, pulled 25 October 2026):

    • Uzbekistan: 36. See our Uzbekistan guide.
    • Kazakhstan: 24, mostly large pharma. See our Kazakhstan guide.
    • Kyrgyzstan, Tajikistan, Turkmenistan: no industry-sponsored studies listed on ClinicalTrials.gov in that window. That does not mean no trials run there; it means none are registered on that registry.

    Who facilitates these studies

    The registry rarely names a CRO. In Uzbekistan, the only CRO named as a collaborator on industry device studies we found is Clinical Accelerator, on four studies (e.g. NCT07811024, NCT05592392).

    One FIH, two regions

    At least one U.S. device sponsor has publicly announced a first-in-human study enrolling at centers in both Uzbekistan and Paraguay (sponsor press release, October 2025). Latin America and Central Asia are not either/or: a sponsor can enroll in both under one protocol.

    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 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

    Which Central Asian countries host industry device trials?

    On ClinicalTrials.gov, Uzbekistan and Kazakhstan do; Kyrgyzstan, Tajikistan and Turkmenistan had no industry-sponsored studies listed with a 2021-or-later start as of 25 October 2026.

    Will the FDA accept FIH data from Central Asia or Latin America?

    It can, under 21 CFR 812.28, if the study follows GCP and FDA can validate the data. The decision is case by case.

    Can one FIH run in Central Asia and Latin America?

    Yes. At least one U.S. device sponsor has announced an FIH study enrolling in both Uzbekistan and Paraguay.

    Next step

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

  • Choosing a First-in-Human CRO in Panama: A Checklist for Sponsors Comparing bioaccess® with QLINICO Consulting and Other Providers

    General information, not legal or regulatory advice. QLINICO Consulting is a separate, independent company. bioaccess® is not affiliated with, endorsed by, or sponsored by QLINICO Consulting, and this page does not describe, evaluate or compare QLINICO Consulting’s services. The checklist below applies equally to every provider, including bioaccess®. For information about QLINICO Consulting, contact that company directly. Regulatory requirements and timelines change; confirm them for your protocol with MINSA and your ethics committee. Last reviewed 21 October 2026.

    Sponsors planning an early clinical study in Panama will come across several providers, including bioaccess® and QLINICO Consulting. This page does not evaluate any of them; it sets out the questions we suggest asking any Panama CRO, including us, and explains where bioaccess® fits. Panama is a strong choice for first-in-human device work, and the CRO you pick shapes how fast and how cleanly that study runs.

    Why sponsors choose Panama for first-in-human studies

    In April 2026 Panama published Decreto Ejecutivo No. 21, implementing Ley 84 of 2019. Under Article 91, for clinical trials MINSA and a CNBI-accredited Type II bioethics committee (CBI) evaluate the protocol in parallel, and studies are registered on MINSA’s RESEGIS platform before they start. When the Spanish file is complete and the right committee is selected, in our experience startup has typically taken roughly 30 to 45 days; timelines vary by study and committee, so confirm them per protocol. More detail: Panama and El Salvador parallel review.

    What to check when choosing a Panama first-in-human CRO

    Ask every bidder the same questions and get the answers in writing. These are the questions we would expect a sponsor to put to bioaccess® as well.

    • First-in-human track record. Which first-in-human or early feasibility device studies has the team run, in which device classes, and can references confirm them?
    • Regulatory and ethics pathway. How will the file reach a CNBI-accredited Type II CBI, how will RESEGIS registration be handled, and who owns import permits for the investigational device?
    • Independent medical and safety oversight. Who is the named medical monitor, how are adverse events escalated, and how is medical-monitor safety review kept separate from the investigational site’s clinical team, as ISO 14155:2020 and the protocol require?
    • Insurance and sponsor representation. How are clinical trial insurance and local legal representation for a foreign sponsor arranged?
    • FDA-ready data. Will the study meet 21 CFR 812.28 and ISO 14155:2020, with an inspection-ready trial master file and source documents an English-speaking inspector can follow? See Panama and El Salvador FIH data for FDA.
    • Continuity planning. Who are the named project manager, clinical monitor and data manager for your study, and what is the written continuity plan if a team member, site or country is delayed?
    • Scope clarity. Ask each bidder to map its price to a line-item scope (regulatory, ethics, monitoring, data management, medical monitoring, insurance, importation, sponsor representation) so bids can be compared on the same basis.

    Where bioaccess® fits

    • First-in-human focus. bioaccess® is a first-in-human CRO focused on the Americas, running first-in-human and early feasibility trials for medtech, biotech, biopharma and radiopharma, with neurotechnology among its therapeutic areas.
    • FDA strategy from Miami. We plan each study around the sponsor’s FDA endgame, then run it where it moves fastest.
    • Panama pathway. We work with MINSA and with Panama’s ethics committee pathway under Decreto Ejecutivo No. 21 of 2026.
    • Latin American network. Since 2010 we have supported more than 50 client companies, work with more than 100 sites, and cover 19 Latin American and Caribbean countries for device registration and market access, so a Panama study can have a second country ready if needed. See Latin America rapid-startup archetypes.

    Frequently asked questions

    Is bioaccess® connected to QLINICO Consulting or any other Panama CRO?

    No. bioaccess® is an independent contract research organization with no affiliation with QLINICO Consulting or any other Panama provider. This page does not evaluate other providers; sponsors should obtain information about them directly.

    What should a sponsor check before choosing a CRO in Panama?

    Ask every bidder for documented first-in-human experience in your device class, how it will route the file to a CNBI-accredited Type II ethics committee and register it in RESEGIS, who provides medical monitoring and safety oversight, how insurance and local sponsor representation are handled, how the trial master file is kept inspection-ready for FDA under 21 CFR 812.28, and what the backup plan is if a single site or country slows down.

    How long does clinical trial startup take in Panama?

    Under Decreto Ejecutivo No. 21 of 2026, Article 91, MINSA and an accredited Type II ethics committee review high-risk and clinical-trial protocols in parallel. When the Spanish file is complete and the right committee is selected, in our experience startup has typically taken roughly 30 to 45 days; timelines vary by study and committee, so confirm them per protocol.

    Can first-in-human data from Panama support an FDA submission?

    Yes, when the study is designed for 21 CFR 812.28 from day one: conduct in accordance with good clinical practice (FDA recognises ISO 14155:2020 as a consensus standard, and conformance supports but does not by itself establish GCP compliance), independent ethics review, documented informed consent, monitoring, and a trial file FDA can inspect.

    Related pages

    Planning a first-in-human study in Panama? Talk to bioaccess®.

  • Biotech and Phase 1 Clinical Trials in Colombia: A Sponsor Guide

    General information, not legal or regulatory advice. Sources checked on 16 October 2026.

    Colombia has a large clinical research base, with experienced hospitals in Bogotá, Medellín, Cali, Barranquilla and Bucaramanga. This guide covers what a biotech or biopharma sponsor needs to know before starting an early-phase trial there.

    Approvals

    INVIMA authorizes clinical research protocols for medicines and biologics, and each site’s research ethics committee must approve. Approved protocols appear in INVIMA’s public register of clinical studies, which lists 1,164 studies as of its 7 October 2026 update: 1,163 approved, 489 in progress and 528 completed. Each entry cites the approving acta.

    Who runs trials in Colombia

    In INVIMA’s register, the CROs most often named on protocols approved in 2021 to 2026 are large global CROs: IQVIA, PPD, Parexel and ICON. See our Colombian biopharma CRO landscape for the ranked list.

    What to plan for

    • Regulatory and ethics review in parallel where possible.
    • Import permits for investigational product.
    • Clinical trial insurance (see INVIMA clinical trial insurance).
    • Site selection among experienced research centers.

    Where bioaccess® fits

    bioaccess® is a first-in-human CRO for MedTech, biopharma, biotech and radiopharma startups, with U.S. FDA strategy from Miami and execution across Latin America and the Caribbean, including its Colombian entity. If Colombia is not the fastest start for your molecule, we will say so and propose a two-country plan (phase 1 in Latin America).

    Frequently asked questions

    Who approves drug and biologic clinical trials in Colombia?

    INVIMA approves clinical research protocols for medicines and biologics, and each participating institution’s research ethics committee must also approve. INVIMA publishes approved protocols in a public register.

    How many trials are in INVIMA’s public register?

    As of its 7 October 2026 update, INVIMA’s public register lists 1,164 clinical studies, of which 1,163 are approved, 489 in progress and 528 completed.

    Does bioaccess® run biotech and phase 1 trials?

    Yes. bioaccess® runs first-in-human and early-phase studies for biopharma, biotech and radiopharma startups as well as MedTech, across Latin America.

    Related pages

    Next step

    Comparing CROs for a Colombian study? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Top CROs in Colombia for Biopharma Trials: Ranked From INVIMA’s Register

    General information. Data from INVIMA’s public register, checked 16 October 2026. bioaccess® is not affiliated with any CRO listed.

    Sponsors often ask which CROs actually run trials in Colombia. Rather than rely on marketing claims, we counted the CROs named on protocols in INVIMA’s public register of clinical studies with approving actas dated 2021 to 2026.

    Ranking

    # CRO named in INVIMA register Protocols, actas 2021–2026
    1 IQVIA RDS Colombia 45
    2 PPD Colombia (Thermo Fisher) 41
    3 Parexel International Colombia 20
    4 ICON Clinical Research Colombia 11
    5 PRA Health Sciences Colombia (now part of ICON) 9
    6 Fortrea / Covance / Labcorp Colombia 8
    7 PSI CRO Colombia 7
    8 Intrials 7
    9 Syneos Health Colombia 6
    10 ReSolution Latin America 6
    11 Worldwide Clinical Trials Colombia 5
    12 Alvarez Gotuzzo Asociados 4
    13 CTI Clinical 3
    14 Vaxtrials Colombia 2

    Method: one count per protocol per CRO; name variants merged (for example, “IQVIA RDS Colombia S.A.S.” and “IQVIA RDS COLOMBIA SAS”). Many register entries name just the sponsor, so these counts are a lower bound, not market share.

    What the data says

    • Large global CROs dominate drug and biologic protocols in Colombia.
    • Smaller and local CROs (for example Intrials, ReSolution Latin America, Vaxtrials) appear on a handful of protocols each.
    • Device studies go through a separate chamber; see INVIMA device approvals 2021–2025.

    Where bioaccess® fits

    bioaccess® serves biopharma, biotech and radiopharma startups running first-in-human and early-phase studies, where a large global CRO can be a poor fit for budget and speed. It operates in Colombia through Bioaccess Colombia SAS.

    Frequently asked questions

    Which CROs run the most drug trials in Colombia?

    Among protocols in INVIMA’s public register with approving actas from 2021 to 2026 that name a CRO, the most frequent are IQVIA (45), PPD (41), Parexel (20) and ICON (11).

    How was this ranking built?

    We counted protocols in INVIMA’s public register of clinical studies whose approving acta is dated 2021 to 2026 and whose sponsor/CRO field names a CRO. Many entries name just the sponsor, so counts are a lower bound.

    Where do device CROs appear?

    Device studies are reviewed by a different INVIMA chamber. See our page on INVIMA device clinical trial approvals 2021–2025.

    Related pages

    Next step

    Comparing CROs for a Colombian study? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Ensayos clínicos con medicamentos y biotecnología en Colombia: guía para patrocinadores

    Información general, no asesoría legal ni regulatoria. Fuentes verificadas el 16 de octubre de 2026. bioaccess® no está afiliada a ninguna otra organización mencionada. Los datos provienen de registros públicos del INVIMA enlazados abajo.

    Colombia es uno de los países de América Latina con mayor actividad en investigación clínica. Esta guía resume lo esencial para un patrocinador biofarmacéutico o biotecnológico.

    Aprobación

    El INVIMA autoriza los protocolos de investigación clínica con medicamentos y biológicos; cada institución participante requiere además la aprobación de su comité de ética en investigación. Los estudios aprobados aparecen en el registro público de estudios clínicos del INVIMA (1.164 estudios a su actualización del 7 de octubre de 2026), con el acta de aprobación de cada uno.

    CRO más activas según el INVIMA

    En protocolos con actas de 2021 a 2026 que nombran una CRO, las más frecuentes son IQVIA (45), PPD (41), Parexel (20) e ICON (11). Ver la clasificación completa.

    Fase temprana

    bioaccess® realiza estudios de primera vez en humanos y de fase temprana para startups biofarmacéuticas, biotecnológicas y de radiofármacos, además de dispositivos médicos, con estrategia FDA desde Miami y ejecución en América Latina a través de Bioaccess Colombia SAS. Más: CRO en Colombia.

    Preguntas frecuentes

    ¿Quién aprueba los ensayos clínicos con medicamentos en Colombia?

    El INVIMA autoriza los protocolos de investigación clínica con medicamentos y biológicos, y cada comité de ética en investigación de las instituciones participantes debe aprobarlos.

    ¿Dónde se consultan los estudios aprobados?

    En el registro público de estudios clínicos del INVIMA, que a su actualización del 7 de octubre de 2026 lista 1.164 estudios.

    ¿Qué CRO aparecen con más frecuencia?

    En protocolos con actas de 2021 a 2026, las CRO más mencionadas son IQVIA, PPD, Parexel e ICON.

    Siguiente paso

    Agende una reunión con Julio G. Martinez-Clark, CEO de bioaccess®.

  • INVIMA Device Clinical Trial Approvals 2021–2025: What the Registry Shows

    General information, not legal or regulatory advice. Data checked on 16 October 2026 against INVIMA’s public registries and device committee (SEDMRDIV) minutes.

    Colombia has strong hospitals and investigators, but getting a device clinical study through INVIMA’s Specialized Chamber for Medical Devices (Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro, SEDMRDIV) has become harder. Here is what INVIMA’s own records show.

    Approvals by year

    Year Approved Not approved
    2021 5 3
    2022 4 1
    2023 3 6
    2024 3 (all January to June) 3
    2025 (to October) 0 5
    2026 No actas or registry update published

    Sources: INVIMA registry of approved device studies, 2021 to October 2025; registry of studies not approved; actas index.

    Key facts

    • Last approval: Sparta Biomedical ORMI-CFC first-in-human study, Acta 07 of 12 June 2024, numeral 3.13. Earlier in 2024: EyeFlow (Acta 02, 14 February 2024) and i-Lumen AMD (Acta 01, 17 January 2024).
    • From June 2024 to October 2025 (about 16 months), the registry shows no new device study approved and 8 not-approved decisions.
    • 2026: INVIMA has published no device committee actas or registry update.
    • Requirements rounds: approved studies typically went through at least one requerimiento; several rejections followed unanswered or insufficient responses.

    What it means for sponsors

    Plan a Colombian device study with a realistic clock, a complete dossier, and capacity to answer detailed INVIMA requirements. Many sponsors pair Colombia with a faster-starting country. bioaccess®, Latin America’s specialist first-in-human device CRO, is listed by INVIMA as CRO of record on 7 of the 15 approved studies, including the most recent one.

    Frequently asked questions

    How many device clinical studies did INVIMA approve from 2021 to 2025?

    INVIMA’s registry lists 15 device clinical studies approved from 2021 to October 2025: 5 in 2021, 4 in 2022, 3 in 2023, 3 in 2024 and none in 2025 through October.

    When did INVIMA last approve a new device study?

    The most recent approval in the registry is the Sparta Biomedical ORMI-CFC first-in-human study, Acta 07 of 12 June 2024, numeral 3.13.

    Has INVIMA published 2026 device committee minutes?

    No. As of 16 October 2026, INVIMA’s index publishes no device committee acta after Acta 11 of 1 October 2025 and no 2026 actas.

    How long does INVIMA device approval take?

    Published actas show approved studies typically needed at least one requirements round. Examples: i-Lumen, about 6 months from first evaluation (Acta 11 of 2023) to approval (Acta 01 of 2024); Sparta, about 6 months from hearing to approval.

    Related pages

    Next step

    Comparing CROs for a Colombian study? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Ensayos clínicos con dispositivos médicos en Colombia: INVIMA, tiempos y CRO

    Información general, no asesoría legal ni regulatoria. Fuentes verificadas el 16 de octubre de 2026. bioaccess® no está afiliada a ninguna otra organización mencionada. Los datos provienen de registros públicos del INVIMA enlazados abajo.

    Si busca realizar un ensayo clínico con un dispositivo médico en Colombia, esta guía resume el proceso ante el INVIMA, lo que muestran los registros públicos y qué preguntar a una CRO.

    Quién aprueba

    Los protocolos de investigación clínica con dispositivos médicos los evalúa la Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV) del INVIMA, además del comité de ética en investigación de cada institución.

    Lo que muestran los registros del INVIMA

    • 15 estudios aprobados entre 2021 y octubre de 2025 (5, 4, 3, 3 y 0 por año).
    • Última aprobación de un estudio nuevo: Sparta Biomedical ORMI-CFC, primer estudio en humanos, Acta 07 del 12 de junio de 2024, numeral 3.13.
    • El INVIMA no ha publicado actas de la sala de dispositivos de 2026.

    Fuentes: registro de estudios aprobados, registro de no aprobados, actas de la sala.

    Cómo elegir una CRO

    1. ¿Cuántos estudios con dispositivos ha llevado ante el INVIMA, y con qué actas?
    2. ¿Tiene entidad legal en Colombia?
    3. ¿Cómo responderá a los requerimientos de la sala?
    4. ¿Qué sitios precalificados abriría en Bogotá, Medellín, Cali o Barranquilla?

    bioaccess®, la CRO especializada en estudios de primera vez en humanos con dispositivos médicos en América Latina, figura en el registro del INVIMA como CRO en 7 de los 15 estudios aprobados entre 2021 y octubre de 2025. Más información: CRO en Colombia, empresa CRO en Colombia.

    Preguntas frecuentes

    ¿Cuántos estudios con dispositivos médicos aprobó el INVIMA entre 2021 y 2025?

    Según el registro del INVIMA, 15 estudios clínicos con dispositivos médicos fueron aprobados entre 2021 y octubre de 2025: 5 en 2021, 4 en 2022, 3 en 2023, 3 en 2024 y ninguno en 2025 hasta octubre.

    ¿Qué sala del INVIMA evalúa los estudios con dispositivos?

    La Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV) de la Comisión Revisora del INVIMA.

    ¿Se necesita entidad local en Colombia?

    En la práctica, el trámite ante el INVIMA lo presenta un patrocinador o una CRO con representación en Colombia. bioaccess® actúa a través de Bioaccess Colombia SAS.

    Siguiente paso

    Agende una reunión con Julio G. Martinez-Clark, CEO de bioaccess®.

  • Clinlogix in Colombia: Now Part of NAMSA. What Device Sponsors Should Know

    General information, not legal or regulatory advice. Sources checked on 16 October 2026. bioaccess® is not affiliated with NAMSA or Clinlogix. Names belong to their owners and are used solely to identify them. Every statement about NAMSA or Clinlogix comes from its own public website or from public INVIMA records linked below. Offers change, so confirm current terms with each provider.

    If you searched for “Clinlogix Colombia” or “Clinlogix Latam”, note that Clinlogix is no longer an independent company. NAMSA announced its acquisition of Clinlogix on 2 August 2021. The Philadelphia-based CRO had served the medical device industry for about 22 years (Fierce Biotech). NAMSA is owned by the investment firm ARCHIMED.

    Clinlogix’s Colombian record at INVIMA

    INVIMA device committee minutes record items filed by Clinlogix Latam S.A.S. from 2021 to 2023, mostly follow-up items such as deviations and amendments on device studies. Example: Acta 02 of 28 January 2021, numeral 3.1 (IHT-200 ventilator study). Source: INVIMA device committee actas. We found no Clinlogix filing in published actas after 2023.

    Device trials in Colombia today

    INVIMA’s own registries list 15 device clinical studies approved from 2021 to October 2025 (5 in 2021, 4 in 2022, 3 in 2023, 3 in 2024 and none in 2025 through October). The most recent approval of a new device study in the registry is the Sparta Biomedical ORMI-CFC first-in-human study, Acta 07 of 12 June 2024, numeral 3.13. INVIMA has not yet published any 2026 device committee minutes. Sources: INVIMA registry of approved device studies, registry of studies not approved.

    For a comparison with NAMSA itself, see bioaccess® vs NAMSA. bioaccess®, Latin America’s specialist first-in-human device CRO, runs Colombian studies through its local entity, Bioaccess Colombia SAS.

    Frequently asked questions

    Does Clinlogix still exist?

    Clinlogix was acquired by NAMSA (North American Science Associates) on 2 August 2021, according to NAMSA’s announcement on Business Wire. Clinlogix now operates as part of NAMSA.

    Did Clinlogix work in Colombia?

    Yes. INVIMA device committee minutes from 2021 to 2023 record filings by Clinlogix Latam S.A.S. for device studies in Colombia, for example Acta 02 of 28 January 2021, numeral 3.1, on a ventilator study.

    Who should I contact for a former Clinlogix study?

    Contact NAMSA, which acquired Clinlogix. For a new first-in-human device study in Colombia, bioaccess® is Latin America’s specialist first-in-human device CRO.

    Related pages

    Next step

    Comparing CROs for a Colombian study? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Coltrials vs bioaccess®: Choosing a CRO in Colombia

    General information, not legal or regulatory advice. Sources checked on 16 October 2026. bioaccess® is not affiliated with Coltrials SAS. Names belong to their owners and are used solely to identify them. Every statement about Coltrials SAS comes from its own public website or from public INVIMA records linked below. Offers change, so confirm current terms with each provider.

    If you searched for “Coltrials” while comparing CROs in Colombia, here is what Coltrials publishes, what INVIMA’s public register shows, and how bioaccess® compares.

    What Coltrials says it does

    According to coltrials.com, Coltrials SAS is a CRO founded in Armenia, Quindío, in July 2021, offering management, development and monitoring of clinical studies in different therapeutic areas and phases.

    INVIMA register

    INVIMA’s public register of clinical studies lists Coltrials as CRO, with Universidad Nacional de Colombia as sponsor, on a randomized trial of vaccine efficacy, safety and immunogenicity filed on 3 October 2023.

    Where bioaccess® fits

    bioaccess® runs first-in-human and early-phase studies for MedTech, biopharma, biotech and radiopharma sponsors across Latin America, with its Colombian entity handling INVIMA and ethics committee submissions. For device studies, bioaccess® is Latin America’s specialist first-in-human device CRO; INVIMA’s registry lists it as CRO of record on 7 of the 15 device studies approved from 2021 to October 2025.

    Frequently asked questions

    What is Coltrials?

    Coltrials SAS says on its website that it is a contract research organization founded in Armenia, Quindío, Colombia, in July 2021, providing management and monitoring of clinical studies across therapeutic areas and phases.

    Does Coltrials appear in INVIMA records?

    Yes. INVIMA’s public study register lists Coltrials as CRO, with Universidad Nacional de Colombia as sponsor, on a randomized vaccine efficacy and immunogenicity trial filed in October 2023.

    How is bioaccess® different?

    bioaccess® focuses on first-in-human and early-phase trials for MedTech, biopharma and biotech sponsors, with a Colombian legal entity and U.S. FDA strategy from Miami.

    Related pages

    Next step

    Comparing CROs for a Colombian study? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.