Category: Advantages of Conducting Trials in Latin America

Figures cited from a ClinicalTrials.gov API v2 facility pull (25 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 Laboratory of Phototherapy and Innovative Technologies in Health São Paulo as a bioaccess® client.

If you searched Laboratory of Phototherapy and Innovative Technologies in Health first-in-human, phototherapy laboratory São Paulo clinical trial, Laboratory of Phototherapy São Paulo device study, or “go direct Laboratory of Phototherapy and Innovative Technologies in Health São Paulo,” you followed a campus string ClinicalTrials.gov still publishes. The Laboratory of Phototherapy and Innovative Technologies in Health in São Paulo, Brazil, is a real named research-laboratory string on ClinicalTrials.gov. On the public records for these registrations, the lead sponsor field reads University of Nove de Julho. 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 laboratory 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 laboratory still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named São Paulo phototherapy laboratory string. It is DISTINCT from the Universidade Nove de Julho university-string page, from the University of São Paulo page, and from the other São Paulo campus pages already published. Sharing a sponsor field or a city is not a license to collapse them. The laboratory string is not the university string, and neither one is a CRO.

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 25 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 25 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.

• Laboratory of Phototherapy and Innovative Technologies in Health (São Paulo, Brazil) — registry strings counted: “Laboratory of Phototherapy and Innovative Technologies in Health”. ALL studies n=14; interventional n=14; DEVICE n=14. Example NCT IDs: NCT03803956, NCT03858179, NCT03879226.

Every one of the 14 is an interventional DEVICE registration on the public record. None of these NCT IDs is cited on the Universidade Nove de Julho 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 laboratory as a client site.

That is the leak: a founder searching the Laboratory of Phototherapy in São Paulo finds ALL n=14 (DEVICE n=14) without finding ANVISA. A named research laboratory is still a site. An NCT location row is not a CRO.

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

A named laboratory 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 laboratory 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 laboratory 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 in this laboratory is not a Universidade Nove de Julho university 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 laboratory

The Laboratory of Phototherapy and Innovative Technologies in Health is a serious named São Paulo research string on the public registry. ALL n=14 and DEVICE n=14 are registry volume, not a punchline. This page is not a critique of phototherapy research. 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 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 Laboratory of Phototherapy and Innovative Technologies in Health São Paulo directly for a device FIH?

You can try. The laboratory 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 laboratory. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Universidade Nove de Julho?

No. Universidade Nove de Julho is the university-string page and is already published. This page is the named phototherapy laboratory string only, with its own NCT IDs.

Did bioaccess® run NCT03803956?

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): Universidade Nove de Julho.

Julio G. Martinez-Clark, CEO · bioaccess®

On a limited budget, the best contract research organization (CRO) for an early-phase trial is one whose model is sized for a single small study: pricing built from your schedule of events, pass-through costs you can audit, and a country plan that lowers site costs and start-up time without weakening the data package. For medical device first-in-human (FIH) and early feasibility studies (EFS), bioaccess® publishes sample first-in-human budgets of about $430K for a 20-subject minimally invasive device study and about $1.32M for a 10-subject surgical implant study (illustrative, not a quote; see bioaccessla.com/sample-budget-fih-trial-latin-america)..

What a limited budget changes

A startup’s first human study is usually funded by one round and judged by the next. The budget question is not only how much, but what each dollar buys toward the milestone your investors and the U.S. Food and Drug Administration (FDA) care about. That shifts CRO selection toward three things: a fee model sized for one small study, fewer surprises after signature, and a country plan that reduces both per-patient cost and months of burn.

Where the money goes in an early-phase study

We split every early-phase budget into three buckets, all priced from the schedule of events, the visit-by-visit list of what happens to each patient. Our budget guide walks through each line.

Bucket	What it covers	Published bioaccess® reference (standard study)
CRO professional fees	Project management, monitoring, regulatory submissions, data management, quality oversight	About $350,000 for 1 site, 10 subjects, 24 months
Third-party costs	Insurance, translations, ethics committee and ministry submission fees, importation, travel	About $50,000
Site and hospital costs	Hospital, investigator and procedure fees negotiated in the clinical trial agreement (CTA)	$5,000–$50,000 in hospital fees, depending on procedure complexity

Pass-throughs are site payments and vendor invoices the CRO pays on your behalf. They should be billed at cost and auditable against the underlying invoices; a general and administrative (G&A) charge of roughly 10–20% over third-party costs covers administering them.

Procedure intensity drives per-patient site cost. Our de-identified benchmarks put an outpatient ophthalmology implant at about $13K per patient, an inpatient orthopedic implant at about $25K–$28K, and a cath-lab peripheral vascular procedure at about $23K–$38K. All of these are planning benchmarks, not quotes.

Six criteria for choosing a CRO on a limited budget

1. A fee model sized for one study. Ask whether pricing is fixed, milestone-based or time-and-materials, and how change orders work. A proposal built from a full protocol and schedule of events is more reliable than one built from a synopsis.
2. Transparent pass-throughs. Every pass-through line should be auditable to an invoice.
3. Country choice as a cost lever. Country changes both cost and time. Our benchmarks put the cost of reaching an approval package at about $188K in Mexico and about $305K in Colombia, where INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) adds a technical-dossier step. Our Panama page publishes per-patient costs of $12K–$22K.
4. Start-up speed. Every month of start-up is a month of burn. In our experience, Panama, Chile, El Salvador and Costa Rica have the region’s quickest review pathways: in our recent plans, ethics and regulatory approval of a complete submission took about 1 to 3 months, while in Colombia, Mexico, Brazil and Argentina the regulator’s review typically adds months. Full site activation, from protocol synopsis to first patient, took about 8 to 9 months in our recent plans. Our site activation timeline guide breaks the clock down by phase.
5. A data package that survives review. A cheaper study is only cheaper if FDA can use the data. Device data must meet 21 CFR 812.28 (Title 21 of the U.S. Code of Federal Regulations, section 812.28).
6. Downstream fit. The early study should hand off cleanly to your pivotal CRO and, for devices, to market access.

How the CRO options compare for a startup

The descriptions come from each company’s own website. The last column lists questions we would ask every one of them, including us.

Model	Example	Relevant public facts	Ask about
FIH/EFS specialist	bioaccess®	First-in-human programs backed by our FIH-12™ performance guarantee; free Pre-Submission (Pre-Sub) gap analysis with a 48-hour turnaround	The three-bucket budget and what the performance guarantee covers
Global full-service CRO	Medpace	Describes itself as a global, full-service CRO and lists Medical Device & Diagnostics among its therapeutic areas	How a small, single-site device study is staffed and priced
Global full-service CRO	Parexel	Describes itself as one of the largest CROs in the world	Which services are in scope for an early-stage device sponsor
Regional or local CRO	Varies	Local presence in one country	FDA design intent and scope exclusions

A first human study of a device needs hospital sites, investigators who already perform the procedure, and a team that runs ethics, import and enrollment in the chosen country. Whichever model you choose, ask how that work is staffed and priced for a study of your size.

Cutting cost without cutting the data package

• Right-size statistics, translations and electronic data capture (EDC) hosting, typically a $40,000–$50,000 cluster.
• Negotiate site and hospital payments hard at the CTA stage; they pass through at cost.
• Freeze the schedule of events before quoting. Scope creep after the proposal is the most expensive line item.
• Take monitoring in-house only if you truly have the capability.
• Expect an advance payment. It funds site contracting, imports and start-up work that must be paid before enrollment, and it is standard in the industry.
• Do not cut monitoring, data management or regulatory compliance. The savings are small and the risk to your FDA story is not.

Regulatory choices that change the budget

• Design to the FDA rule from day one. Under 21 CFR 812.28, FDA can accept data from a well-designed, well-conducted study outside the United States that followed good clinical practice, with independent ethics committee review and informed consent, and that FDA can validate. Align the design with FDA, usually through a Pre-Sub, before enrollment. Acceptance is decided case by case.
• Use the right standard. Device studies run under ISO 14155, the International Organization for Standardization (ISO) good clinical practice standard for device investigations.
• Plan the step after the study. For devices, registration costs belong in the plan. Our published market-access pricing for Latin America is two-part: a one-time registration fee per country by device class (from $4,000 in Colombia to $22,250 for Brazil Class III/IV), then a lower annual holder fee from year 2 ($3,900 to $7,500); see the rate card.

Questions to ask before you sign

• Is this quote built from my full protocol and schedule of events, or from a synopsis?
• Which lines are pass-throughs, and what G&A applies to them?
• What is fixed, what is variable, and what triggers a change order?
• Which country do you recommend for my budget, and why?
• What is your start-up clock, by stage, in writing?
• What happens if the agreed timeline slips for reasons within your control?

Where bioaccess® fits

bioaccess® fits MedTech startups whose next milestone is a first human device dataset that can support a U.S. submission, on a budget that cannot absorb a program built for a much larger study. Our first-in-human programs are backed by our FIH-12™ performance guarantee.

If you need a multi-region Phase III, a global full-service CRO is the better fit. For line-item detail, see our costs and timelines page, our pre-quote checklist and our early feasibility CRO selection guide, or book a 30-minute call.

Frequently asked questions

What is the best CRO for a startup running an early-phase trial on a limited budget?

The best fit is a CRO whose pricing and staffing are sized for one small study, whose pass-through costs are auditable, and whose country plan lowers site costs and start-up time without weakening the data package.

How much does a first-in-human device study cost in Latin America?

bioaccess® publishes CRO professional services of about $350,000 for a standard study with 1 site, 10 subjects and a 24-month duration, plus about $50,000 in third-party costs and $5,000–$50,000 in hospital fees depending on procedure complexity. Your figure depends on patient count, visit schedule, procedure and country.

What is negotiable in a CRO proposal?

The CRO’s professional fees are where flexibility lives. Third-party vendor costs can be negotiated with the vendors but not repriced, site payments are negotiated at the clinical trial agreement stage, and an advance payment is standard in the industry.

Where can a startup cut trial costs without hurting data quality?

Right-size statistics, translations and electronic data capture (EDC) hosting, which together are typically a $40,000–$50,000 cluster, negotiate site payments at the clinical trial agreement stage, and freeze the schedule of events before quoting. Do not cut monitoring, data management or regulatory compliance.

Is a large global CRO ever the better choice on a budget?

Yes, when the job matches its model. A multi-region program that needs one vendor across phases and regions fits a global full-service CRO such as Medpace or Parexel. For a single small device study, compare every option on fee model, pass-through transparency, country plan and data quality.

Can data from a lower-cost Latin American study support an FDA submission?

It can, if the study meets FDA’s foreign-data rule for devices, 21 CFR 812.28. That means a well-designed, well-conducted study under good clinical practice, with independent ethics committee review, informed consent and data FDA can validate. Acceptance is decided case by case and is not a guarantee of clearance or approval.

Fast regulatory approval in Latin America comes from two choices made together: the right country pathway and a contract research organization (CRO) that already works that pathway every week. For first-in-human (FIH) and early feasibility medical device studies, bioaccess® concentrates on the region’s fastest-start jurisdictions, where in our experience Panama, Chile, El Salvador and Costa Rica have the quickest review pathways: in our recent plans, ethics and regulatory approval of a complete submission took about 1 to 3 months. Global full-service CROs such as Parexel and Medpace also list Latin American offices on their websites and are built for larger multi-country programs.

This article explains what “approval” really covers, compares the main countries using the timelines we already publish, and gives criteria for judging any CRO on regulatory speed.

What “fast approval” actually includes

Sponsors often ask about the regulator alone. The clock you actually wait on has four parts:

• Ethics committee review of the protocol, informed consent form (ICF) and investigator. Depending on the country, the committee is called a CEI (Comité de Ética en Investigación), an Ethical-Scientific Committee or an institutional review board (IRB).
• National regulatory authorization, where the country requires it for an investigational device.
• Investigational device import, through a formal, traceable import permit.
• Site contract and activation, including the clinical trial agreement (CTA).

In the fastest markets, ethics and regulator submissions run in parallel rather than one after the other. Across Latin America, ethics committees routinely review FIH protocols on a timeline set by each committee’s meeting schedule, compared with 6 to 12 months in the U.S.

Activation is not the same as first patient in. Qualifying and contracting the investigators who will enroll takes 1 to 3 months and should run in parallel with regulatory start-up; after approvals, the first patient typically follows in about a month.

Country by country: where approval is fastest

The table uses only timelines already published on bioaccessla.com. Treat them as indicative planning figures, not guarantees; committee calendars and agency queues change.

Country	Authority and ethics route	Published bioaccess® indication
Panama	MINSA (Ministerio de Salud) with ethics committees registered with CNBI (Comité Nacional de Bioética de la Investigación); Decreto 21 of 2026 implements Titles III and IV of Ley 84 of 14 May 2019	3–5 week ethics approval, with MINSA clearance available concurrently; one program activated in about 15 days
Chile	ISP (Instituto de Salud Pública); Law 20.120 requires a favorable review from an accredited Ethical-Scientific Committee	Typical ISP review of about 30 business days; see our site activation timeline guide for the full start-up path
El Salvador	Dirección Nacional de Medicamentos (DNM) and national ethics review	About 1.5 to 3 months from submission to approval in our recent plans
Costa Rica	Ministerio de Salud (Ministry of Health)	Ethics committee first, then CONIS registration; see our Costa Rica activation calendar
Colombia	INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) plus ethics	6–9 months to start, per our startup-clock guide
Mexico	COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) plus ethics	6–9 months; the agency is in transition, so confirm current clocks at contracting
Brazil	ANVISA (Agência Nacional de Vigilância Sanitária) plus ethics	6–9 months
Argentina	ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) plus ethics	6–9 months

Small markets can activate quickly and still enroll slowly. Choose the country on real site-level patient flow for your indication, not on the clock alone, and test two or three countries in feasibility before committing. Our startup-clock guide and our fast-track corridor deep dive go country by country.

A note on Colombia

Colombia is where bioaccess® built its earliest FIH capability, and we have completed 30+ FIH device studies there. The additional INVIMA technical-dossier step is why our benchmarks put the cost of reaching an approval package in Colombia at roughly 1.6 times Mexico’s. We still run clinical trials in Colombia and recommend it when the device, sites and file fit.

How to judge a CRO on regulatory speed

1. Pathway ownership. Has the team filed your exact pathway, for your device class, recently? Ask for de-identified submission and approval dates.
2. In-country entity and importer of record. A CRO with a local legal entity can own submissions and imports directly. In Colombia, for example, our Colombian entity owns INVIMA submissions, ethics-committee work and investigational-device import.
3. Parallel submissions. Ask which submissions the CRO runs in parallel in your country, and which must be sequential.
4. Dossier quality and translation. Most start-up delay is rework, not review. Submissions must be in Spanish or Portuguese; bioaccess® works with its sister company Amavita Sciences™, the group’s in-house Latin American regulatory-translation infrastructure.
5. Query turnaround. A slow answer to a committee question is the biggest avoidable delay. Ask how the CRO tracks and answers queries, and how fast.
6. A written clock. Ask for the timeline by country and by stage, in writing, before you sign.
7. U.S. Food and Drug Administration (FDA) design intent. Speed is worth little if the data cannot support your U.S. submission.

How the CRO options compare in Latin America

CRO	Latin America presence (per each company’s website)	Designed for
bioaccess®	50+ pre-qualified sites across 19 Latin American and Caribbean markets; lead FIH jurisdictions Panama, El Salvador, Chile and the Dominican Republic; a Colombian legal entity and office	FIH and early feasibility studies for startups, plus device registration
Parexel	Offices in Argentina, Brazil and Mexico, with clinical trial supplies and logistics depots in Argentina and Brazil	Large programs across phases and regions
Medpace	Offices listed in Argentina, Brazil and Mexico	Full-service programs across phases and regions
Regional CROs and site networks	One country or sub-region	Single-country studies

Presence is not the same as pathway speed. Whichever CRO you consider, ask who would own local ethics, regulatory and import work day to day, and ask for its own recent clocks in your target country for your device class.

Speed and FDA acceptance are compatible

Under 21 CFR 812.28 (Title 21 of the U.S. Code of Federal Regulations, section 812.28), FDA can accept data from a well-designed, well-conducted study outside the United States when it followed good clinical practice (GCP), including independent ethics committee review and informed consent, and FDA can validate the data. How quickly a study was approved is not one of those conditions. Device studies should run under ISO 14155, the International Organization for Standardization (ISO) GCP standard for device investigations, and design should be aligned with FDA, typically through a Pre-Submission, before enrollment. Eligibility for FDA review is not a guarantee of clearance or approval. Our FDA acceptance guide covers the rule in detail.

Questions to ask a CRO about approval timelines

• What were your last three approval clocks in this country for a device like mine?
• Which steps run in parallel, and which are sequential?
• Who is importer of record, and when is the import permit filed?
• Who translates the dossier, and who answers committee queries?
• What happens contractually if the agreed timeline slips?

Where bioaccess® fits

bioaccess® fits sponsors who want FIH or early feasibility data from the region’s fastest-start jurisdictions, with one team handling ethics, regulatory, import and site activation, and a U.S. regulatory anchor. Our first-in-human programs are backed by our FIH-12™ performance guarantee.

Speed also has a budget side: every month of start-up is a month of burn. Our costs and timelines page and our FIH budget guide show how country choice changes both. If your program is a multi-region Phase III, a global full-service CRO is the better structural fit. See our ethics committee timelines, Latin America FIH benchmarks and country hubs, or book a 30-minute call.

Frequently asked questions

Which Latin American country has the fastest clinical trial approval for a device first-in-human study?

In our experience, Panama, Chile, El Salvador and Costa Rica are the fastest: in our recent plans, ethics and regulatory approval of a complete submission took about 1 to 3 months, and site activation from protocol synopsis to first patient about 8 to 9 months. The right choice still depends on whether the country’s sites can enroll your indication.

Which CROs are best for fast regulatory approval in Latin America?

Look for a CRO that has filed your exact country pathway recently, can act as importer of record, submits to ethics and regulator in parallel, and puts a country-by-country clock in writing. bioaccess® is a first-in-human CRO built around the region’s fastest-start jurisdictions; global full-service CROs such as Parexel and Medpace list Latin American offices and are built for larger multi-country programs.

How long does ethics committee approval take in Latin America?

Latin American ethics committees routinely review first-in-human protocols on a timeline set by each committee’s meeting schedule, compared with 6 to 12 months in the U.S. In Panama, bioaccess® publishes a 3–5 week ethics approval.

Does bioaccess® still run clinical trials in Colombia?

Yes. bioaccess® still runs clinical trials in Colombia and recommends it when the device, sites and file fit. INVIMA, ethics and import work sit with our Colombian legal entity.

Does faster approval make the data less useful for the FDA?

No. Under 21 CFR 812.28, what matters is that the study was well designed and well conducted under good clinical practice, with independent ethics committee review and informed consent, and that FDA can validate the data. How quickly the study was approved is not one of the conditions.

Do I need national regulator approval as well as ethics approval?

It depends on the country and device class. Colombia, for example, requires INVIMA authorization for an investigational device, while in some other countries the ethics committee is the primary gate. Confirm the requirement for each country during feasibility.

Names and roles cited from ClinicalTrials.gov study record NCT07431723 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched James Hamilton MD first-in-human, James Hamilton Chile clinical trial, Dr Hamilton MEDS La Dehesa CRO, GT Metabolic magnet anastomosis Chile PI, Clínica MEDS investigator, or “go direct James Hamilton, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is digestive / metabolic anastomosis device investigation (GT Metabolic magnet compression anastomosis on the public brief title). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact or OverallOfficial field is not a CRO.

This page answers the Hamilton search. Matching facility page: Clínica MEDS La Dehesa Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

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

Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

• Name: James Hamilton, MD.
• NCT07431723 — RECRUITING DEVICE row; location PRINCIPAL_INVESTIGATOR “James Hamilton, MD” / Clinica MEDS La Dehesa SpA (creation of compression anastomosis using the GT Metabolic magnet system on the public brief title).
• Affiliation on this page: Clinica MEDS La Dehesa SpA from the public NCT row above.

We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent specialty board certifications. Emailing a named contact confirms interest. It does not open ISP.

The contact is the contact. The CRO is the operator.

What a named PI or site contact can typically do when a sponsor “goes direct”:

• Discuss clinical interest and whether a protocol fits their service line.
• Point toward institutional ethics calendars and campus research rules.
• Help estimate local visit and procedure effort for cases they will run.

What a named contact 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 pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that stack.
• Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
• Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
• Multi-country optionality if the indication later needs another Latin American country.

Going direct to a name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 OUS FIH and FDA IDE.

Not a critique of the investigator

James Hamilton, MD, is a named public NCT principal investigator on a serious DEVICE row at Clinica MEDS La Dehesa SpA for the GT Metabolic magnet anastomosis program. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a campus only if it fits.

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. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I email James Hamilton, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, 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 NCT07431723?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for James Hamilton, MD?

ClinicalTrials.gov cites location PRINCIPAL_INVESTIGATOR “James Hamilton, MD” / Clinica MEDS La Dehesa SpA on NCT07431723.

Is this the same page as Clínica MEDS La Dehesa Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Clínica MEDS La Dehesa Santiago and this page James Hamilton, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Clínica MEDS La Dehesa Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study record NCT05353777 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Ignacio Robles MD first-in-human, Ignacio Robles Chile clinical trial, Dr Robles Hospital FACH CRO, Levita robotic platform Chile PI, FACH Santiago investigator, or “go direct Ignacio Robles, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is surgical / robotic-platform device investigation (Levita robotic platform clinical evaluation on the public brief title). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact or OverallOfficial field is not a CRO.

This page answers the Robles search. Matching facility page: Hospital FACH Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

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

Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

• Name: Ignacio Robles, MD.
• NCT05353777 — COMPLETED DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Ignacio Robles, MD” / Hospital FACH (clinical evaluation of the Levita robotic platform on the public brief title).
• Affiliation on this page: Hospital FACH from the public NCT row above.

We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent specialty board certifications. Emailing a named contact confirms interest. It does not open ISP.

The contact is the contact. The CRO is the operator.

What a named PI or site contact can typically do when a sponsor “goes direct”:

• Discuss clinical interest and whether a protocol fits their service line.
• Point toward institutional ethics calendars and campus research rules.
• Help estimate local visit and procedure effort for cases they will run.

What a named contact 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 pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that stack.
• Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
• Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
• Multi-country optionality if the indication later needs another Latin American country.

Going direct to a name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 OUS FIH and FDA IDE.

Not a critique of the investigator

Ignacio Robles, MD, is a named public NCT principal investigator on a serious DEVICE row at Hospital FACH for the Levita robotic platform program. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a campus only if it fits.

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. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I email Ignacio Robles, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, 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 NCT05353777?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Ignacio Robles, MD?

ClinicalTrials.gov cites OverallOfficial PRINCIPAL_INVESTIGATOR “Ignacio Robles, MD” / Hospital FACH on NCT05353777.

Is this the same page as Hospital FACH Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Hospital FACH Santiago and this page Ignacio Robles, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Hospital FACH Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study records NCT06915337 and NCT06915818 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Pablo Marin MD first-in-human, Pablo Marin Chile clinical trial, Dr Marin Colonial Chile CRO, magnet anastomosis Colonial PI, Flexagon OTOLoc Chile investigator, or “go direct Pablo Marin, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is digestive / surgical anastomosis device investigation (magnet gastric anastomosis and Flexagon Plus OTOLoc colon anastomosis on the public brief titles). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact or OverallOfficial field is not a CRO.

This page answers the Marin search. Matching facility page: Clínica Colonial Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

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

Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

• Name: Pablo Marin, MD.
• NCT06915337 — RECRUITING DEVICE row; location CONTACT and OverallOfficial PRINCIPAL_INVESTIGATOR “Pablo Marin, MD” / Clinica Colonial Hospital (magnet anastomosis in patients undergoing gastric surgery on the public brief title).
• NCT06915818 — RECRUITING DEVICE row; location CONTACT and OverallOfficial PRINCIPAL_INVESTIGATOR “Pablo Marin, MD” / Clinica Colonial Hospital (Flexagon Plus OTOLoc colon anastomosis on the public brief title).
• Affiliation on this page: Clinica Colonial Hospital from the public NCT rows above.

We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent specialty board certifications. Emailing a named contact confirms interest. It does not open ISP.

The contact is the contact. The CRO is the operator.

What a named PI or site contact can typically do when a sponsor “goes direct”:

• Discuss clinical interest and whether a protocol fits their service line.
• Point toward institutional ethics calendars and campus research rules.
• Help estimate local visit and procedure effort for cases they will run.

What a named contact 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 pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that stack.
• Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
• Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
• Multi-country optionality if the indication later needs another Latin American country.

Going direct to a name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 OUS FIH and FDA IDE.

Not a critique of the investigator

Pablo Marin, MD, is a named public NCT principal investigator and site contact on serious DEVICE rows at Clinica Colonial Hospital spanning magnet gastric and Flexagon colon anastomosis programs. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a campus only if it fits.

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. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I email Pablo Marin, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, 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 NCT06915337 or NCT06915818?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Pablo Marin, MD?

ClinicalTrials.gov cites CONTACT and OverallOfficial PRINCIPAL_INVESTIGATOR roles at Clinica Colonial Hospital on NCT06915337 and NCT06915818.

Is this the same page as Clínica Colonial Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Clínica Colonial Santiago and this page Pablo Marin, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Clínica Colonial Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study record NCT05871983 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Martín Valdebenito MD first-in-human, Martin Valdebenito Chile clinical trial, Dr Valdebenito Sotero del Rio CRO, Munich TMVR Chile PI, Sótero del Río investigator, or “go direct Martín Valdebenito, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is structural / interventional cardiology device investigation (Munich transcatheter mitral valve on the public brief title). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact or OverallOfficial field is not a CRO.

This page answers the Valdebenito search. Matching facility page: Hospital Dr. Sótero del Río Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

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

Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

• Name: Martín Valdebenito, MD.
• NCT05871983 — NOT_YET_RECRUITING DEVICE row; location CONTACT and PRINCIPAL_INVESTIGATOR “Martín Valdebenito, MD” / Hospital Dr Sotero Del Rio De Santiago (Munich transcatheter mitral valve safety and effectiveness).
• Affiliation on this page: Hospital Dr Sotero Del Rio De Santiago from the public NCT row above.

We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent specialty board certifications. Emailing a named contact confirms interest. It does not open ISP.

The contact is the contact. The CRO is the operator.

What a named PI or site contact can typically do when a sponsor “goes direct”:

• Discuss clinical interest and whether a protocol fits their service line.
• Point toward institutional ethics calendars and campus research rules.
• Help estimate local visit and procedure effort for cases they will run.

What a named contact 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 pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that stack.
• Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
• Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
• Multi-country optionality if the indication later needs another Latin American country.

Going direct to a name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 OUS FIH and FDA IDE.

Not a critique of the investigator

Martín Valdebenito, MD, is a named public NCT principal investigator and site contact on a serious DEVICE row at Hospital Dr Sotero Del Rio De Santiago for the Munich mitral program. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a campus only if it fits.

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. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I email Martín Valdebenito, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, 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 NCT05871983?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Martín Valdebenito, MD?

ClinicalTrials.gov cites CONTACT and PRINCIPAL_INVESTIGATOR roles at Hospital Dr Sotero Del Rio De Santiago on NCT05871983.

Is this the same page as Hospital Dr. Sótero del Río Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Hospital Dr. Sótero del Río Santiago and this page Martín Valdebenito, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Hospital Dr. Sótero del Río Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study record NCT01348828 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Renato Mertens MD first-in-human, Renato Mertens Chile clinical trial, Dr Mertens Universidad Catolica CRO, Endologix fenestrated stent graft Chile PI, UC Católica vascular investigator, or “go direct Renato Mertens, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is vascular / endovascular device investigation (Endologix fenestrated stent graft feasibility and safety on the public brief title). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact or OverallOfficial field is not a CRO.

This page answers the Mertens search. Matching facility page: Hospital Clínico Universidad Católica Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

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

Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

• Name: Renato Mertens, MD.
• NCT01348828 — COMPLETED DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Renato Mertens, MD” / Hospital Universidad Catolica (feasibility and safety study of the Endologix fenestrated stent graft system on the public brief title).
• Affiliation on this page: Hospital Universidad Catolica from the public NCT row above.

We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent specialty board certifications. Emailing a named contact confirms interest. It does not open ISP.

The contact is the contact. The CRO is the operator.

What a named PI or site contact can typically do when a sponsor “goes direct”:

• Discuss clinical interest and whether a protocol fits their service line.
• Point toward institutional ethics calendars and campus research rules.
• Help estimate local visit and procedure effort for cases they will run.

What a named contact 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 pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that stack.
• Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
• Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
• Multi-country optionality if the indication later needs another Latin American country.

Going direct to a name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 OUS FIH and FDA IDE.

Not a critique of the investigator

Renato Mertens, MD, is a named public NCT principal investigator on a serious DEVICE feasibility-and-safety row at Hospital Universidad Catolica for the Endologix fenestrated stent graft program. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a campus only if it fits.

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. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I email Renato Mertens, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, 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 NCT01348828?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Renato Mertens, MD?

ClinicalTrials.gov cites OverallOfficial PRINCIPAL_INVESTIGATOR “Renato Mertens, MD” / Hospital Universidad Catolica on NCT01348828.

Is this the same page as Hospital Clínico Universidad Católica Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Hospital Clínico Universidad Católica and this page Renato Mertens, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Hospital Clínico Universidad Católica Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study record NCT07470411 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Susana Benitez Seguel first-in-human, Susana Benitez Chile clinical trial, Benitez Seguel Las Condes CRO, MACS surgical Chile PI, Clínica Las Condes investigator, or “go direct Susana Benitez Seguel,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is surgical device investigation (MACS safety and feasibility in surgical procedures on the public brief title). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact or OverallOfficial field is not a CRO.

This page answers the Benitez search. Matching facility page: Clínica Las Condes Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

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

Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

• Name: Susana Benitez Seguel (as published on ClinicalTrials.gov — we do not invent an MD suffix).
• NCT07470411 — RECRUITING DEVICE row; location PRINCIPAL_INVESTIGATOR “Susana Benitez Seguel” / Clinica Las Condes (safety and feasibility of the MACS in surgical procedures on the public brief title).
• Affiliation on this page: Clinica Las Condes from the public NCT row above.

We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent specialty board certifications. Emailing a named contact confirms interest. It does not open ISP.

The contact is the contact. The CRO is the operator.

What a named PI or site contact can typically do when a sponsor “goes direct”:

• Discuss clinical interest and whether a protocol fits their service line.
• Point toward institutional ethics calendars and campus research rules.
• Help estimate local visit and procedure effort for cases they will run.

What a named contact 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 pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that stack.
• Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
• Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
• Multi-country optionality if the indication later needs another Latin American country.

Going direct to a name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 OUS FIH and FDA IDE.

Not a critique of the investigator

Susana Benitez Seguel is a named public NCT principal investigator on a serious DEVICE safety-and-feasibility row at Clinica Las Condes for the MACS surgical program. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a campus only if it fits.

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. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I email Susana Benitez Seguel directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, 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 NCT07470411?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Susana Benitez Seguel?

ClinicalTrials.gov cites location PRINCIPAL_INVESTIGATOR “Susana Benitez Seguel” / Clinica Las Condes on NCT07470411. We do not invent an MD title beyond that public string.

Is this the same page as Clínica Las Condes Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Clínica Las Condes Santiago and this page Susana Benitez Seguel.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Clínica Las Condes Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study record NCT05695989 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Julio Jimenez MD first-in-human, Julio Jimenez Chile clinical trial, Dr Jimenez Hospital Tisne CRO, Levita dual robotic arm Chile PI, Luis Tisné surgical investigator, or “go direct Julio Jimenez, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is surgical / robotic-platform accessory device investigation (dual robotic arm accessory with Levita magnetic surgical system on the public brief title). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact or OverallOfficial field is not a CRO.

This page answers the Jimenez search. Matching facility page: Hospital Luis Tisné Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

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

Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

• Name: Julio Jimenez, MD.
• NCT05695989 — COMPLETED DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Julio Jimenez, MD” / Hospital Tisne (safety and feasibility of the dual robotic arm accessory with the Levita magnetic surgical system on the public brief title).
• Affiliation on this page: Hospital Tisne from the public NCT row above.

We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent specialty board certifications. Emailing a named contact confirms interest. It does not open ISP.

The contact is the contact. The CRO is the operator.

What a named PI or site contact can typically do when a sponsor “goes direct”:

• Discuss clinical interest and whether a protocol fits their service line.
• Point toward institutional ethics calendars and campus research rules.
• Help estimate local visit and procedure effort for cases they will run.

What a named contact 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 pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that stack.
• Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
• Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
• Multi-country optionality if the indication later needs another Latin American country.

Going direct to a name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 OUS FIH and FDA IDE.

Not a critique of the investigator

Julio Jimenez, MD, is a named public NCT principal investigator on a serious DEVICE safety-and-feasibility row at Hospital Tisne for the Levita dual robotic arm accessory program. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a campus only if it fits.

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. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I email Julio Jimenez, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, 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 NCT05695989?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Julio Jimenez, MD?

ClinicalTrials.gov cites OverallOfficial PRINCIPAL_INVESTIGATOR “Julio Jimenez, MD” / Hospital Tisne on NCT05695989.

Is this the same page as Hospital Luis Tisné Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Hospital Luis Tisné Santiago and this page Julio Jimenez, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Hospital Luis Tisné Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®