If you search CRO in Paraguay or CRO en Paraguay, you should land on the First-in-Human CRO that already works the DINAVISA file — not a brochure about an emerging destination, and not a press file that names a surgeon and calls that the CRO.
bioaccess® is that CRO. Headquarters in Miami. DINAVISA (Dirección Nacional de Vigilancia Sanitaria) authorizes clinical investigations. An institutional Comité de Ética en Investigación sits in front of enrollment. We run clinical trials in Paraguay.
I am Julio Martinez-Clark, CEO of bioaccess®. This is the operator page for the query. Colombia, Argentina, and Venezuela are sibling country categories. We still run trials in those countries. Paraguay is not a replacement for any of them.
What “CRO in Paraguay” has to mean
A Paraguay CRO for first-in-human devices is not a Latin America slide and a courier account. It is a company that can file with DINAVISA in Spanish, sit the institutional ethics committee, keep investigational import moving, and stay in the room after first patient in.
That is why this page answers CRO in Paraguay / CRO en Paraguay as a category, and why it does not invent a Paraguayan legal entity. We have not published one. Miami headquarters plus the DINAVISA file is the line that is already live.
- Miami headquarters — sponsor desk on US Eastern time.
- DINAVISA — Dirección Nacional de Vigilancia Sanitaria, under the Ministry of Public Health and Social Welfare, already named on the Paraguay hub and in llms.txt.
- Ethics 4–6 weeks and $10,000–$18,000 per patient — the numbers already on that hub. Lowest band we publish in Latin America.
- Asunción metro ~2.5 million, treatment-naïve enrollment, ISO 14155 — already on the hub.
- Dr. Adrián Ebner and Hospital Italiano Asunción — a site, already public on this site. Not this CRO.
Global Phase 3 networks can list Paraguay. They rarely hold the DINAVISA first-in-human file. A named Asunción surgeon can run the procedure. That surgeon is not the CRO.
We run trials in Paraguay
The old marketing hero on the hub sold “emerging destination” and a country we were still “developing” and “pre-qualifying.” That is not the category. The category is: who is the CRO in Paraguay, and are they actually running studies.
We are. We still will. If you are choosing a CRO en Paraguay in 2026, ask whether the firm owns the DINAVISA clock now — not whether the country is “opening up.”
DINAVISA review can move, stall, or come back with questions. First-in-human programs need a start date someone owns. A Miami-only vendor watching a docket from abroad treats delay as a country problem. The CRO that already works DINAVISA treats delay as responses, ethics alignment, import, and site activation on one timeline.
That is Global Trial Accelerators™ in practice: one accountable operating model across DINAVISA, ethics, sites, insurance, importation, monitoring, and safety.
DINAVISA clinical trial: the file, not the myth
DINAVISA is the Dirección Nacional de Vigilancia Sanitaria. It sits under the Ministry of Public Health and Social Welfare. I am not inventing a PAHO/WHO Level 4 badge for DINAVISA. llms.txt lists Paraguay as “DINAVISA.” Level 4 is not on that list, and I will not put it here.
What the file actually contains, already listed on the hub: the clinical investigation protocol, investigator brochure, informed consent documents, investigator credentials, and proof of adequate insurance. Live Paraguay process blogs on this site already name Resolution No. 1.000/2015 among the study-authorization instruments. I am not inventing a new instrument list or a new DINAVISA day-count. Ethics on the hub is 4–6 weeks. Ask for a study-specific calendar.
Those are authority-and-instrument names. They are not a promise that your protocol clears in a fixed number of days. Incomplete packages stall. That is a file problem.
Ethics sits first — 4–6 weeks already published
Clinical trials in Paraguay require approval from an institutional ethics committee (Comité de Ética en Investigación) before enrollment. The hub already publishes 4–6 weeks. Committees follow ISO 14155 principles and review scientific merit, risk-benefit, informed consent, and patient protection. Ethics sits in front of a useful DINAVISA clock. If the committee package is thin, the country is not the problem. The file is.
Dr. Adrián Ebner is a site — do not hire the PI as the CRO
Dr. Adrián Ebner, Head of the Cardiovascular Department at Hospital Italiano / Sanatorio Italiano / Italian Hospital, Asunción, is a real first-in-human cardiovascular investigator. That fact is already on live pages on this site — Adrian Ebner Paraguay FIH and Hospital Italiano Asunción FIH. Searches for Adrián Ebner Paraguay, Sanatorio Italiano Asunción FIH, and Hospital Italiano Asunción correctly point at that site.
The hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in a public press file, become your DINAVISA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. bioaccess® does not operate Hospital Italiano and does not treat Dr. Ebner as the CRO. Use the site when it fits. Hire the operator.
Greater Asunción (about 2.5 million metro, already on the hub) is the public geography. We do not operate a named Paraguayan hospital. A city is not a site contract. If you need a named PI and a named ward, that is a feasibility deliverable — not a sentence I will invent beyond what is already public.
FDA use of Paraguayan first-in-human data
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets good clinical practice as that rule defines it, including ethics-committee review and informed consent. bioaccess® designs Paraguay studies with that FDA conversation in mind — electronic data capture, structured safety reporting, source data verification — under ISO 14155 with DINAVISA authorization and ethics-committee approval.
Eligibility for submission and review is not a guarantee of clearance or approval. ISO 14155 is the device GCP standard we align the file to. It is not a stamp the FDA owes you.
Cost — use the numbers already on the hub
The Paraguay hub already publishes $10,000–$18,000 per patient — the lowest band we publish in Latin America — and $150K–$250K all-in for a typical 10-patient FIH study. Those figures already include investigator fees, site costs, ethics fees, regulatory submissions, and patient-related expenses. I am not inventing a new band here.
The same hub already compares that band with $15K–$25K in Colombia and $12K–$22K in Panama, and with $40K–$75K in the United States and $35K–$60K in Europe. Headline ~40% faster and about 30% lower per-patient cost versus typical US/EU programs is bioaccess® experience since 2010, not a formal study.
This article does not quote LATAM Launch subscription pricing. That SKU lives on the market-access pages, not on a first-in-human hub.
Questions a sponsor should ask any CRO in Paraguay
- Are you running clinical trials in Paraguay now — not “historically”?
- Who owns the DINAVISA clock when the file sits?
- Can you file the study package in Spanish and sit the Comité de Ética en Investigación before enrollment?
- Do you claim DINAVISA is PAHO/WHO Level 4, or do you stay with what is already published?
- Are you mixing Dr. Adrián Ebner or Hospital Italiano — a site — into the CRO pitch?
- Do you claim to operate a named Paraguayan hospital, or do you contract sites?
- Will the study file be built for 21 CFR 812.28, and do you understand that eligibility is not clearance?
bioaccess® answers: trials running; Miami HQ; DINAVISA and ethics owned as a file problem; no Level 4 invented for DINAVISA; Dr. Ebner and Hospital Italiano named as a site we do not operate; no invented Paraguayan legal entity; FDA conversation designed in from day one.
How Paraguay sits next to Colombia, Argentina, and Venezuela
Do not read this as “leave Colombia.” We still run clinical trials in Colombia. That country has a local Colombian entity and its own hub. Argentina has ANMAT and its own hub. Venezuela has INHRR and its own hub. Paraguay is a sibling country category. INVIMA stays INVIMA. ANMAT stays ANMAT. INHRR stays INHRR. DINAVISA stays DINAVISA. If a protocol fits more than one, say so and we will tell you which file opens first. We will not flip one country into the other.
See clinical trials in Paraguay, clinical trials in Argentina, clinical trials in Colombia, and clinical trials in Venezuela.
How to start
If you need a CRO in Paraguay / CRO en Paraguay for a first-in-human or early-feasibility device study, contact bioaccess® through bioaccessla.com/contact.
Bring the protocol stage, device class, and whether Asunción is the only geography that fits. We will tell you how the DINAVISA clock would run. We will not tell you to leave the country. We will not invent a legal entity, a hospital we operate, a Level 4 badge, or a day-count we have not already published.
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