cms.bioaccessla.com

Author: Julio Martinez-Clark

  • IDE vs IND: Which FDA Pathway Does Your Device Need?

    IDE vs IND: Which FDA Pathway Does Your Device Need?

    If you are building a medical device and preparing for first-in-human testing, one of the earliest regulatory decisions you face is whether your clinical program falls under an Investigational Device Exemption (IDE) or an Investigational New Drug (IND) application. The IDE vs IND question shapes everything downstream: which FDA center reviews your submission, how long that review takes, what risk classification applies, and which marketing pathway you are ultimately building toward.

    Getting this wrong early is costly. Sponsors who structure their clinical evidence under the wrong framework can face submission rejections, protocol redesigns, or data packages that do not support their intended U.S. clearance or approval pathway. This article explains the core differences between IDE and IND, walks through the decision logic, and covers the scenarios where both apply simultaneously.

    What Each Pathway Covers

    IDE: The Medical Device Route

    An IDE allows a medical device that has not yet received FDA clearance or approval to be used in a clinical study on human subjects. As ora.research.ucla.edu noted in its 2021 report, a medical device is considered investigational if it is not approved for marketing in the U.S. or is being clinically evaluated for a new indication. The IDE framework is governed by 21 CFR Part 812 and reviewed by the Center for Devices and Radiological Health (CDRH).

    The IDE pathway exists to generate the clinical evidence a sponsor needs to support a downstream 510(k), De Novo, PMA, or Humanitarian Device Exemption (HDE) submission. The clinical data collected under an IDE is the foundation for those marketing applications.

    IND: The Drug and Biologic Route

    An IND application covers investigational drugs, biologics, and certain gene therapies. It is governed by 21 CFR Part 312 and reviewed by either the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER), depending on the product type. Radiopharmaceuticals, for example, typically fall under CDER or CBER depending on their intended use and mechanism.

    The IND pathway leads downstream to a New Drug Application (NDA) or Biologics License Application (BLA). Clinical development is phase-based: Phase 1 for safety and dose-finding, Phase 2 for efficacy signals, Phase 3 for pivotal evidence.

    The Risk-Tier Fork: A Key Difference in the Device Pathway

    One of the most consequential distinctions between IDE and IND is the risk-tiering step that exists only in the device pathway. According to CASRAI, the medical device pathway requires a classification of significant-risk (SR) or non-significant-risk (NSR) — a step with no equivalent in the drug pathway.

    This classification determines how much FDA oversight your study carries.

    Significant-Risk (SR) devices require a full IDE application submitted to and approved by FDA before the study begins. SR devices are those that present a potential for serious risk to health, safety, or welfare — implantable devices, devices that support or sustain human life, and devices used in diagnosing or treating serious conditions all fall into this category.

    Non-Significant-Risk (NSR) devices do not require a formal IDE submission to FDA. Instead, the sponsor obtains approval from an Institutional Review Board (IRB) or Ethics Committee (EC) and proceeds under an abbreviated IDE. Informed consent, proper labeling, and study monitoring are still required — but the FDA review step is replaced by IRB oversight.

    This fork matters enormously for startup planning. An NSR determination can compress your pre-study timeline substantially. An SR determination puts you in a formal FDA review cycle before a single patient is enrolled.

    Review Timelines and the 30-Day Default

    For IND applications, CASRAI notes that FDA uses a 30-day default review period, after which a sponsor may proceed unless a clinical hold is issued. If FDA does not respond within 30 days, the sponsor is cleared to begin the study.

    The IDE review process works differently. FDA has 30 days to review an IDE application, but for SR devices, FDA must affirmatively approve the IDE before the study begins. There is no default-to-proceed mechanism for a full IDE. That distinction is operationally significant: an IND sponsor can plan around a 30-day window with reasonable confidence, while an IDE sponsor for an SR device must wait for explicit approval.

    Both pathways also require IRB or EC approval at the site level, running in parallel to the FDA review. In the U.S., that parallel process can add weeks to months depending on the institution.

    Downstream Marketing Pathways: Why the Starting Point Matters

    The pathway you enter at the investigational stage determines the marketing application you will file later. This is not a technicality — it defines the evidence standard your clinical data must meet from day one.

    Starting Pathway Governing Regulation Reviewing Center Downstream Application
    IDE 21 CFR Part 812 CDRH 510(k), De Novo, PMA, HDE
    IND 21 CFR Part 312 CDER or CBER NDA, BLA

    If you are a device company pursuing a 510(k) or PMA, your clinical data must be structured under the IDE framework and ISO 14155 to be accepted in that submission. Data collected under an IND structure will not substitute for IDE-governed device evidence in a CDRH review. The reverse is equally true.

    This is why regulatory strategy alignment at the Pre-Sub stage is not optional. The FDA's Pre-Submission (Q-Sub) program exists precisely to resolve pathway questions before a sponsor commits resources to a clinical program.

    When Both an IDE and an IND Apply

    Combination products — those that combine a device component with a drug or biologic component — can require both an IDE and an IND. Drug-eluting stents, implantable drug delivery systems, and devices incorporating a biologic agent are all examples where both frameworks may apply.

    In these cases, FDA assigns a primary mode of action (PMOA) to determine the lead reviewing center. If the device function is primary, CDRH leads. If the drug or biologic function is primary, CDER or CBER leads. The non-lead center still reviews the submission, but the lead center sets the standards and timelines.

    Radiopharmaceutical developers face a version of this complexity. Compounds like Lu-177, Ac-225, and Ga-68 involve both a device delivery mechanism and a drug or biologic component, which means the regulatory strategy must account for both centers from the outset.

    When an IDE Is Not Required

    Not every device study requires an IDE. FDA exempts certain categories of device studies from the IDE requirement entirely:

    • Studies of devices that are already legally marketed, when the study is not intended to determine safety or effectiveness for a new indication
    • Diagnostic device studies that meet specific criteria, including no significant risk to subjects and use of cleared devices within their labeled indications
    • Consumer preference studies that do not involve any risk to subjects
    • Studies involving devices exempt under 21 CFR 812.2(c)

    Whether your study qualifies for an exemption is part of the Pre-Sub conversation with FDA. Sponsors who assume an exemption applies without confirming it are exposed to significant compliance risk.

    How This Decision Affects Your FIH Strategy in Latin America

    For MedTech startups running first-in-human studies outside the U.S., the IDE vs IND determination has direct implications for how clinical data is structured and whether it will be accepted in a U.S. submission.

    Data collected under ISO 14155 and structured per FDA 21 CFR 812.28 is accepted for U.S. IDE and IND submissions when properly structured. That qualifier matters. A study run in Panama, Colombia, or Chile under a CRO that does not anchor its protocol architecture to the sponsor's U.S. regulatory pathway will generate data that may not survive CDRH or CDER review.

    bioaccess® anchors every FIH program to the sponsor's intended U.S. pathway from day one. Whether that pathway is IDE toward a PMA, IND toward a BLA, or a combination product strategy, the FIH-12™ program structures the protocol, data collection, and evidence package to meet the applicable FDA standard. FDA Pre-Sub and pathway alignment is the first of 9 workstreams — not an afterthought.

    This approach has produced FDA-submissible evidence packages for sponsors across a range of device categories. The enVVeno Medical case study illustrates how a LATAM first-in-human program was structured to support what became the first-ever FDA IDE for a non-surgical replacement venous valve. The Cook Group case study documents a multi-site FIH program in Colombia with 142-plus INVIMA regulatory submissions managed, all structured for U.S. submission readiness.

    Ophthalmic device sponsors can see a similar approach in the ClarVista Medical case study, where LATAM first-in-human data supported a program that ended in a ClarVista acquisition by Alcon. For sponsors in retinal therapy, the i-Lumen Scientific case study covers a novel device program for age-related macular degeneration run through the same framework.

    The speed advantage in Latin America — where ethics and regulatory approvals have been observed in 30 to 90 days in Panama, El Salvador, Chile, and the Dominican Republic — only produces value if the data generated meets the FDA standard your downstream application requires. Pathway clarity before the study starts is what makes that speed useful rather than just fast.

    Making the IDE vs IND Decision: A Practical Framework

    Before filing anything, work through these questions in order.

    1. What is your product? If it is a drug, biologic, or gene therapy with no device component, you are in IND territory. If it is a device with no drug or biologic component, you are in IDE territory. If it combines both, you need a PMOA determination.

    2. What is your downstream marketing application? Targeting 510(k), De Novo, PMA, or HDE means your clinical data must be structured under the IDE framework. Targeting NDA or BLA means it must be structured under IND.

    3. What is the risk classification of your device? SR or NSR — this determines whether you need a full IDE submission to FDA or can proceed under an abbreviated IDE with IRB approval.

    4. Does your study qualify for an IDE exemption? Confirm with FDA through a Pre-Sub if there is any ambiguity.

    5. Where are you running the study? If outside the U.S., confirm that your CRO structures data collection under ISO 14155 and 21 CFR 812.28 to ensure FDA acceptability.

    FAQs

    What is the difference between an IDE and an IND?
    An IDE (Investigational Device Exemption) governs clinical studies of unapproved medical devices under 21 CFR Part 812, reviewed by CDRH. An IND (Investigational New Drug) governs clinical studies of drugs and biologics under 21 CFR Part 312, reviewed by CDER or CBER. The pathway you enter determines the downstream marketing application you can file and the evidence standard your clinical data must meet.

    Which FDA center reviews IDE applications?
    CDRH reviews IDE applications. IND applications are reviewed by CDER (drugs) or CBER (biologics), depending on the product type.

    What is the difference between a significant-risk and non-significant-risk device?
    A significant-risk (SR) device presents a potential for serious risk and requires a full IDE submission with FDA approval before the study begins. A non-significant-risk (NSR) device does not require a formal FDA submission; the sponsor proceeds under an abbreviated IDE with IRB or Ethics Committee approval.

    Can a clinical study require both an IDE and an IND?
    Yes. Combination products that include both a device component and a drug or biologic component may require both an IDE and an IND. FDA assigns a primary mode of action to determine the lead reviewing center, but both centers review the submission.

    How long does FDA take to review an IDE application?
    FDA has 30 days to review an IDE application. For significant-risk devices, FDA must affirmatively approve the IDE before the study begins — there is no default-to-proceed mechanism, unlike IND applications, where a sponsor may proceed after 30 days if no clinical hold is issued.

    Does data collected in Latin America satisfy FDA IDE or IND requirements?
    Data collected under ISO 14155 and structured per FDA 21 CFR 812.28 is accepted for U.S. IDE and IND submissions when properly structured. The critical factor is that the CRO managing the study anchors its protocol architecture and data collection to the sponsor's specific U.S. regulatory pathway from the start of the program.

    When is an IDE not required for a device study?
    IDE requirements do not apply to studies of legally marketed devices used within their cleared indications, certain diagnostic device studies meeting specific criteria, consumer preference studies without subject risk, and categories specifically exempted under 21 CFR 812.2(c). Sponsors should confirm any exemption claim through an FDA Pre-Submission before proceeding.

    Conclusion

    The IDE vs IND decision is not administrative paperwork. It is the regulatory foundation your entire clinical program is built on. Get it right before the protocol is written, before the CRO is engaged, and before a single patient is screened. A misclassified pathway, a misstructured data package, or an unconfirmed exemption assumption are expensive and time-consuming to correct.

    If you are at the pre-clinical to IDE/IND-ready stage and need to map your pathway before your next funding milestone, bioaccess® builds that strategy into the first workstream of every FIH-12™ program. Visit bioaccessla.com to get your FIH roadmap.

  • Can Panama or El Salvador FIH data support an FDA IDE, 510(k), De Novo, or PMA?

    US MedTech founders ask this in almost every Panama or El Salvador first-in-human (FIH) scoping call: “If we run the early cases outside the US, will FDA take the data for an IDE, 510(k), De Novo, or PMA?”

    I am Julio Martinez-Clark, CEO of bioaccess®. Short answer: yes, foreign clinical data can support those files — when you design the study for 21 CFR 812.28 from day one. A fast ethics letter on the wrong protocol is not an FDA asset. This page is the operator cut for Panama and El Salvador. It sits next to our Panama FIH Class III guide, the LATAM vs Australia early-feasibility comparison, and the early feasibility vs pivotal brief. Not a quote and not legal advice.

    One-sentence answer

    Panama or El Salvador FIH data can enter an FDA strategy when the investigation meets the good clinical practice (GCP) and supporting-information rules in 21 CFR 812.28 — including an inspectable trial file — and when the investigational device is identical to the US device or you submit a detailed comparison.

    What 21 CFR 812.28 actually tests

    FDA’s foreign-clinical-data rule is not a country whitelist. It asks whether the investigation was conducted under a GCP standard for design, conduct, monitoring, auditing, recording, analysis, and reporting that keeps data credible and protects subjects. That standard includes independent ethics-committee review and approval before initiation, continuing review, and documented freely given informed consent.

    FDA has stated that conformance with ISO 14155:2020 will generally satisfy the GCP requirement of 812.28. Investigations initiated on or after 21 February 2019 must conform to the 2018 foreign-data framework. Country of conduct is relevant for import, ethics, and site quality. It is not a substitute for 812.28 design.

    Significant-risk devices: build the full 812.28(b) set

    For a significant-risk device as defined in 21 CFR 812.3(m) — the Class III / high-risk biomaterial FIH case — plan the full supporting set in 812.28(b):

    • Investigators and sites
    • Protocol and results
    • A statement that the investigational device is identical to the US device, or a detailed comparison of differences
    • Valid scientific evidence under 21 CFR 860.7 if you claim safety and effectiveness
    • Independent ethics committee (IEC) identity meeting 812.3(t)
    • Consent, monitoring, and investigator GCP training documentation

    FDA can validate the data through an onsite inspection or other appropriate means. A Panama or El Salvador file that cannot be inspected is not an 812.28 file. Electronic data capture, device accountability, and source documents that survive an English-speaking inspector are part of study design — not a later translation job.

    Do not plan to live in 812.28(e)

    Section 812.28(e) is the residual clause: even when a foreign study does not fully meet paragraph (a), FDA may still accept the information if it believes the data are credible and accurate and that subject rights were adequately protected. That is a reviewer safety valve. It is not a protocol strategy. Build paragraph (a). Treat (e) as the exception you hope never to need.

    Why Panama and El Salvador show up in the same answer

    Both countries are used for early device cohorts when sponsors need surgical or hospital volume outside a US IDE queue. Panama’s investigational desk runs under Ley 84 of 2019 and Decreto Ejecutivo No. 21 of 2026 (CNBI-accredited Type II ethics, RESEGIS, parallel MINSA review for higher-risk protocols). El Salvador is often the second country in a multi-country early plan when enrollment or anatomy needs a wider net — the same pattern already described on our Panama FIH guide (Panama plus El Salvador plus Brazil as an example multi-country frame).

    For FDA usability, the country pair matters less than whether both sites run one protocol, one monitoring plan, one device configuration, and one TMF standard. Two local “quick starts” with divergent ICFs and unaccounted devices will not stitch into an 812.28 package later.

    What makes OUS data fail the FDA conversation

    • Protocol written for local approval only, with inclusion, imaging, and device deficiencies redefined after the fact for a US file
    • Investigational configuration that quietly differs from the US device without a comparison table
    • English-only or incomplete source that cannot support inspection
    • Mixing commercial registro (Panama DNDM / Ley 90–Decreto 490) with the trial authorization and assuming market clearance equals clinical evidence
    • Hoping 812.28(e) will rescue a study that never ran ISO 14155 discipline

    Operator checklist before first patient in Panama or El Salvador

    1. Write the US intended use and device configuration on one page. Lock whether the OUS unit is identical or document every difference.
    2. Design the protocol once for ISO 14155:2020 monitoring, consent, and SAE clocks — then map local ethics and ministry steps underneath it.
    3. Confirm ethics committees meet the independence expectations behind 812.3(t) and keep approval letters in the TMF.
    4. Build EDC, device accountability, and source so an FDA inspector can follow a subject without a scavenger hunt.
    5. Keep commercial registro off the FIH critical path. Trial authorization is not a license to sell.

    Talk with bioaccess® when you need a Panama or El Salvador FIH framed so the same dataset can later support an IDE conversation or a marketing submission under 21 CFR 812.28 — without inventing a country whitelist FDA does not publish.

  • How to register a medical device in Panama with MINSA (DNDM)

    Sponsors keep mixing two Panama desks into one email: “we need MINSA for our device.” One desk is commercial registro sanitario. The other is clinical-research authorization. They are not the same petition, and swapping them mid-cycle is how a quarter disappears.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page answers the market-access question — how a medical device gets onto the Panamanian market under MINSA’s Dirección Nacional de Dispositivos Médicos (DNDM) — and how that file stays off the first-in-human critical path. It sits next to our LATAM market-access hub, the Importer of Record guide, and the Panama FIH device guide. Operator guidance only. Not a quote and not legal advice.

    One-sentence answer

    Commercial sale in Panama is a sanitary-registration file under Ley 90 of 26 December 2017 (as modified by Ley 92 of 12 September 2019) and Decreto Ejecutivo No. 490 of 4 October 2019, with DNDM as the classifying authority and a single Authorized Representative as the regulatory anchor. A MINSA/CNBI trial authorization is not a license to sell.

    Two MINSA desks — write them on separate pages

    Investigational use. Protocol review under Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C), with ethics at a CNBI-accredited Type II committee and RESEGIS registration before start. That path is for first-in-human and other clinical research. See the Decreto 21 explainer.

    Commercial registro. Sale and distribution of a medical device that already has a clearance story elsewhere (often FDA or CE) follows Ley 90 / Ley 92 and Decreto 490. Risk class for registro sanitario follows current GHTF/IMDRF rules; DNDM classifies. The named Authorized Representative is the regulatory face of the product and, in Panama’s single-representative model, the importer-of-record anchor.

    If your Gantt has one bar labeled “MINSA,” you do not have a plan. You have a hope.

    What the single Authorized Representative model means

    Panama is a single-representative market. The representative on the registro is the sanitary face of the device. Changing that name is closer to a new market entry than a contract amendment — the same pattern we describe for other single-AAR Central American markets on the independent registration-holder strategy page.

    Design implication for US and European manufacturers: do not put the commercial distributor on the certificate if you want the option to change channel later. Hold titularidad with an entity that answers to the manufacturer’s transfer doctrine — then authorize distributors underneath that holder.

    What belongs in the commercial dossier (operator list)

    Exact forms and annexes move with DNDM practice. The working stack sponsors assemble before translators start is stable:

    • Device identification, intended use, and GHTF/IMDRF risk class as DNDM will see it
    • Manufacturer and manufacturing sites, with quality-system evidence appropriate to class
    • Technical file / essential-requirements evidence already used for FDA or CE, mapped to the Panamanian petition — not dumped as a zip of US folders
    • Labels and IFU in Spanish for the configuration you will sell
    • Authorized Representative appointment and local entity documentation
    • Tecnovigilancia ownership under the holder, not under whichever distributor won the first tender

    Electrical/EMC or RF homologation for wireless devices, when required, runs through Panama’s telecom authority as a separate vendor track. Do not bury that inside the sanitary clock.

    What this file is not

    • It is not a substitute for Decreto 21 ethics + MINSA research review when you still need human data.
    • It is not an investigational import permit. Trial units enter under the research authorization; commercial units enter under registro.
    • It is not a free pass to use a Panama FIH as proof of market clearance. First patient in and registro sanitario are different end states.

    How bioaccess® handles Panama registration

    On the live Panama MINSA market-access page, bioaccess® processes your registration funded by you (dossier, translations, agency liaison) and sells registration processing there, not a holder subscription: in Panama the titleholder must also be the importer, so there is no annual holder fee. Panama is not on the published-pricing list (Mexico, Colombia, Brazil, Peru and Argentina) and is quoted case by case. Timelines are confirmed at proposal against the current DNDM queue — we do not invent a statutory day-count here.

    Operator checklist before you open a Panama registro folder

    1. Write “trial” and “registro” on two pages. Put owners and statutes on each page.
    2. Decide the Authorized Representative before you pick a distributor.
    3. Confirm the configuration you will sell matches the labels and IFU you will file — not the investigational configuration from an FIH.
    4. Map FDA/CE evidence to the DNDM petition; do not ship the US zip as the dossier.
    5. Budget tecnovigilancia and holder change cost as part of channel design, not as a later surprise.

    Talk with bioaccess® when you need Panama registro held independent of the commercial channel — or when you are sequencing a Panama FIH under Decreto 21 into a later DNDM market file without mixing the desks.

  • Universidade Metodista de Piracicaba (UNIMEP): The NCT Campus String Is Not the ANVISA File

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    How ANVISA actually works (the short version)

    Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

    Not a critique of the university

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

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

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

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

    Colombia is still on the map

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

    Frequently asked questions

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

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

    Did bioaccess® run the NCT IDs listed here?

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

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

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

    Did bioaccess® run NCT01484834?

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

    Next step

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

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Centro Paulista de Oncologia São Paulo: The NCT Campus String Is Not the ANVISA File

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    How ANVISA actually works (the short version)

    Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

    Not a critique of the clinic

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

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

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

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

    Colombia is still on the map

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

    Frequently asked questions

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

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

    Did bioaccess® run the NCT IDs listed here?

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

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

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

    Did bioaccess® run NCT01478269?

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

    Next step

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

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Federal University of Juiz de Fora (UFJF): The NCT Campus String Is Not the ANVISA File

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    How ANVISA actually works (the short version)

    Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

    Not a critique of the university

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

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

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

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

    Colombia is still on the map

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

    Frequently asked questions

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

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as CMiP Juiz de Fora?

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

    Did bioaccess® run NCT00545103?

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

    Next step

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

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Churruca (Churruca-Visca) Buenos Aires: The NCT Campus String Is Not the ANMAT File

    Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Argentina’s National Administration of Drugs, Foods and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Hospital Churruca Buenos Aires as a bioaccess® client.

    If you searched Hospital Churruca Visca Buenos Aires first-in-human, Hospital Churruca clinical trial, Churruca-Visca device study, or “go direct Hospital Churruca Buenos Aires,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Churruca in Buenos Aires, Argentina (also registered as Hospital Churruca Visca and Hospital Churruca-Visca), is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANMAT file.

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

    This page is the named Buenos Aires Hospital Churruca / Churruca-Visca campus. It is DISTINCT from Hospital General de Agudos Dr. Cosme Argerich, Hospital Italiano de Buenos Aires, and other Buenos Aires campuses already published. Sharing Buenos Aires is not a license to collapse them.

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

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

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

    • Hospital Churruca (Buenos Aires, Argentina) — registry strings counted: “Hospital Churruca”; “Hospital Churruca – Visca”; “Hospital Churruca Visca”; “Hospital Churruca-Visca”. ALL studies n=10; interventional n=9; DEVICE n=1. Example NCT IDs: NCT00026338, NCT00036647, NCT00040183.

    Aliases are counted once per NCT ID for Buenos Aires locations; 1 of the 10 are observational.

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

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

    That is the leak: a founder searching Hospital Churruca in Buenos Aires finds ALL n=10 (DEVICE n=1) without finding ANMAT. A named hospital campus is still a site. An NCT location row is not a CRO.

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

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

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

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

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

    • ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at Hospital Churruca is not an Argerich file and is not an ANMAT file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
    • ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How ANMAT actually works (the short version)

    Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.

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

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

    Not a critique of the hospital

    Hospital Churruca is a serious named Buenos Aires campus on the public registry. ALL n=10 and DEVICE n=1 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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

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

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

    Colombia is still on the map

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

    Frequently asked questions

    Can I contract Hospital Churruca Buenos Aires directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Hospital Italiano de Buenos Aires or other CABA hospitals?

    No. Those are distinct Buenos Aires campus pages when live. This page is Hospital Churruca / Churruca-Visca only.

    Did bioaccess® run NCT00026338?

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

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Argentina sibling: other Buenos Aires campus pages on the bioaccess® blog.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Universidad Católica del Maule Talca: The NCT Campus String Is Not the ISP File

    Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Chile’s Public Health Institute (Instituto de Salud Pública, ISP), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Universidad Católica del Maule Talca as a bioaccess® client.

    If you searched Universidad Catolica del Maule Talca first-in-human, Universidad Católica del Maule clinical trial, UCM Talca device study, or “go direct Universidad Católica del Maule Talca,” you followed a campus string ClinicalTrials.gov still publishes. Universidad Católica del Maule in Talca, Chile (including the Campus San Miguel spelling on the registry), is a real named university-campus string on ClinicalTrials.gov. No separate live university-string page for this institution exists yet. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ISP file.

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

    This page is the named Talca Universidad Católica del Maule university string. It is DISTINCT from Centro de Investigación del Maule Talca, from Hospital Clínico Universidad Católica Santiago (CMS — Hospital Clínico Universidad Católica), and from other Maule or Católica campuses. Sharing Talca or Católica is not a license to collapse them. This is the whole university string, not a lab or school subunit of a university that already has a live page.

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

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

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

    • Universidad Católica del Maule (Talca, Chile) — registry strings counted: “Universidad Catolica del Maule”; “Universidad Católica del Maule”; “Universidad Católica del Maule – Campus San Miguel”. ALL studies n=10; interventional n=9; DEVICE n=2. Example NCT IDs: NCT02692911, NCT04251728, NCT05456282.

    Aliases including Campus San Miguel are counted once per NCT ID for Talca locations; 1 of the 10 are observational.

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

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

    That is the leak: a founder searching Universidad Católica del Maule in Talca finds ALL n=10 (DEVICE n=2) without finding ISP. A named university campus is still a site. An NCT location row is not a CRO.

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

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

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

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

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

    • ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at Universidad Católica del Maule is not a Centro de Investigación del Maule file and is not an ISP file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
    • ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How ISP actually works (the short version)

    Use Clinical Trials in Chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

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

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

    Not a critique of the university

    Universidad Católica del Maule is a serious named Talca campus on the public registry. ALL n=10 and DEVICE n=2 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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

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

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

    Colombia is still on the map

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

    Frequently asked questions

    Can I contract Universidad Católica del Maule Talca directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Centro de Investigación del Maule Talca?

    No. Centro de Investigación del Maule Talca is a distinct Talca research-center page already published. This page is the Universidad Católica del Maule university string only.

    Did bioaccess® run NCT02692911?

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

    Next step

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

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Instituto de Cardiologia de Santa Catarina (São José): The NCT Campus String Is Not the ANVISA File

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

    If you searched Instituto de Cardiologia de Santa Catarina first-in-human, ICSC Sao Jose clinical trial, Instituto Cardiologia Santa Catarina device study, or “go direct Instituto de Cardiologia de Santa Catarina,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Cardiologia de Santa Catarina in São José, Santa Catarina, Brazil, is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

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

    This page is the named São José Instituto de Cardiologia de Santa Catarina campus. It is DISTINCT from Instituto de Cardiologia do Rio Grande do Sul, Instituto Nacional de Cardiologia Rio de Janeiro, Instituto Nacional de Cardiología Ignacio Chávez (Mexico), and Florianópolis / Joinville campuses already published. Sharing the word Cardiologia or Santa Catarina is not a license to collapse them.

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

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

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

    • Instituto de Cardiologia de Santa Catarina (São José, Brazil) — registry strings counted: “Instituto de Cardiologia de Santa Catarina”. ALL studies n=12; interventional n=11; DEVICE n=1. Example NCT IDs: NCT01741558, NCT01754675, NCT02343276.

    Counted once per NCT ID for São José locations; 1 of the 12 are observational.

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

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

    That is the leak: a founder searching Instituto de Cardiologia de Santa Catarina in São José finds ALL n=12 (DEVICE n=1) without finding ANVISA. A named hospital campus is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

    How ANVISA actually works (the short version)

    Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

    Not a critique of the hospital

    Instituto de Cardiologia de Santa Catarina is a serious named São José campus on the public registry. ALL n=12 and DEVICE n=1 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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

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

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

    Colombia is still on the map

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

    Frequently asked questions

    Can I contract Instituto de Cardiologia de Santa Catarina directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Instituto de Cardiologia do Rio Grande do Sul?

    No. That is a different state and a different campus string. This page is Instituto de Cardiologia de Santa Catarina in São José only.

    Did bioaccess® run NCT01741558?

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

    Next step

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

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Dr. Hernán Henríquez Aravena Temuco: The NCT Campus String Is Not the ISP File

    Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current rules from Chile’s Public Health Institute (Instituto de Salud Pública, ISP), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Hospital Dr. Hernán Henríquez Aravena Temuco as a bioaccess® client.

    If you searched Hospital Hernan Henriquez Aravena Temuco first-in-human, Hospital Dr Hernán Henríquez Aravena clinical trial, Temuco hospital device study, or “go direct Hospital Dr. Hernán Henríquez Aravena Temuco,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Dr. Hernán Henríquez Aravena in Temuco, Chile, is a real named hospital-campus string on ClinicalTrials.gov, registered under several accent and abbreviation spellings. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ISP file.

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

    This page is the named Temuco Hospital Dr. Hernán Henríquez Aravena campus. It is DISTINCT from Hospital Clínico Universidad de La Frontera Temuco strings, from Clínica Alemana Temuco, and from Santiago ISP-path campuses already published. Sharing Temuco or a regional health service is not a license to collapse them.

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

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

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

    • Hospital Dr. Hernán Henríquez Aravena (Temuco, Chile) — registry strings counted: “Hospital Dr Hernan Henriquez Aravena”; “Hospital Dr Hernán Henríquez Aravena”; “Hospital Dr. Hernan Henriquez Aravena”; “Hospital Dr. Hernán Henríquez Aravena”; “Hospital Hernan Henriquez Aravena”; “Hospital Hernán Henríquez Aravena”. ALL studies n=16; interventional n=11; DEVICE n=1. Example NCT IDs: NCT00412893, NCT00413218, NCT00467857.

    Aliases are counted once per NCT ID for Temuco locations; 5 of the 16 are observational. We do not invent a combined Universidad de La Frontera count on this page.

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

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

    That is the leak: a founder searching Hospital Dr. Hernán Henríquez Aravena in Temuco finds ALL n=16 (DEVICE n=1) without finding ISP. A named hospital campus is still a site. An NCT location row is not a CRO.

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

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

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

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

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

    • ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at Hospital Dr. Hernán Henríquez Aravena is not a Universidad de La Frontera file and is not an ISP file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
    • ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF). The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How ISP actually works (the short version)

    Use Clinical Trials in Chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

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

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

    Not a critique of the hospital

    Hospital Dr. Hernán Henríquez Aravena is a serious named Temuco campus on the public registry. ALL n=16 and DEVICE n=1 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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

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

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

    Colombia is still on the map

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

    Frequently asked questions

    Can I contract Hospital Dr. Hernán Henríquez Aravena Temuco directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Universidad de La Frontera Temuco?

    No. This page is the named Hospital Dr. Hernán Henríquez Aravena campus only. A university-string page is a different page if and when it is live.

    Did bioaccess® run NCT00412893?

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

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Chile sibling (do not merge): Hospital Clínico San Borja Arriarán Santiago.

    Julio G. Martinez-Clark, CEO · bioaccess®