If you search CRO in Uruguay or CRO en Uruguay, you should land on the First-in-Human CRO that already runs MSP / DIGESA and Decreto 158/019 work — not a brochure that treats Uruguay as a slide on a Latin America map.
bioaccess® is that CRO. Headquarters in Miami. The Ministry of Public Health (MSP), through its General Directorate of Health (DIGESA), regulates clinical research. Decreto 158/019 and the National Commission of Ethics in Research sit in front of first patient in. We run clinical trials in Uruguay.
I am Julio Martinez-Clark, CEO of bioaccess®. This is the operator page for the query. Colombia, Chile, and Venezuela are sibling country categories. We still run trials in those countries. Uruguay is not a replacement for any of them.
What “CRO in Uruguay” has to mean
A Uruguay CRO for first-in-human devices is not a Latin America slide and a courier account. It is a company that can file with MSP / DIGESA, sit both ethics tracks under Decreto 158/019, keep investigational import moving under Decree 3/008, and stay in the room after first patient in.
That is why this page answers CRO in Uruguay / CRO en Uruguay as a category, and why it does not list a named Uruguayan company on the trial hub. The live Uruguay MSP market-access page already says bioaccess® can act as a neutral Uruguayan Local Holder on a bespoke fee. That is a registration option. It is not a hospital we operate, and it is not a reason to mix a commercial file into a first-in-human quote.
- Miami headquarters — sponsor desk on US Eastern time. Uruguay is +1 to +2 hours versus the US East Coast, already published on the Uruguay hub.
- MSP / DIGESA — Ministry of Public Health acting through the General Directorate of Health, the national authority overseeing clinical research.
- Decreto 158/019 — research on humans; National Commission of Ethics in Research (Comisión Nacional de Ética en Investigación) assessment to MSP DIGESA, plus institutional ethics committee approval in parallel.
- Decree 3/008 — medical devices; MERCOSUR member; investigational-device import under the MSP/DIGESA framework.
- ~30% lower versus typical US/EU programs — experience since 2010, not a formal study. Already on the hub.
- 21 CFR 812.28 — eligibility for FDA submission and review is not clearance or approval.
Global Phase 3 networks can list Uruguay. They rarely hold the MSP / DIGESA first-in-human file. A local correspondent can courier a package. That correspondent is not the CRO.
We run trials in Uruguay
The category is: who is the CRO in Uruguay, and are they actually running studies. We are. We still will. If you are choosing a CRO en Uruguay in 2026, ask whether the firm owns the MSP / DIGESA clock now — not whether the country is “opening up.”
MSP / DIGESA 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 MSP / DIGESA 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 MSP / DIGESA, both ethics tracks, sites, insurance, importation, monitoring, and safety.
MSP / DIGESA clinical trial: the file, not the myth
MSP is the Ministry of Public Health. DIGESA is its General Directorate of Health. Together they are Uruguay’s national authority for clinical research. I am not inventing a PAHO/WHO Level 4 badge for MSP / DIGESA. llms.txt Regulatory Agencies does not list MSP / DIGESA. Level 4 is not on that list, and I will not put it here.
The live hub already names the instruments: Decreto 158/019 for research involving human subjects; Decree 3/008 for medical devices; MERCOSUR membership for regional device alignment; ISO 14155 and the Declaration of Helsinki as study standards. I am not inventing a new instrument list.
What the file actually contains, already described on that hub: MSP/DIGESA coordination, National Commission of Ethics submissions, institutional ethics review, and an investigational-device import authorization so product can be shipped into the country. Foreign sponsors still need someone who can sit both ethics tracks and the deficiency cycle. bioaccess® serves that role.
Those are authority-and-instrument names. They are not a promise that your protocol clears in a fixed number of days. Ask for a study-specific calendar. We will not publish an invented median on a category page.
Decreto 158/019 and the two committees that sit first
Research involving human subjects in Uruguay is governed by Decreto 158/019. Under this framework, the National Commission of Ethics in Research (Comisión Nacional de Ética en Investigación) reviews studies and sends its assessment to MSP’s General Directorate of Health. In parallel, the institutional ethics committee of the research institution must approve protocols. Uruguayan clinical research follows ISO 14155 and the Declaration of Helsinki. That paragraph is already on the hub. I am repeating it because sponsors skip one of the two ethics tracks and then blame the country.
Ethics sits in front of MSP / DIGESA. If either committee package is thin, the DIGESA clock does not start in a useful way. That is a file problem.
MSP registration is a second file — keep it off the trial clock
Clinical-study authorization and commercial device registration are different files. The live Uruguay MSP market-access page already describes a strict single-Local-Holder model: the Local Holder is the only entity authorised to import the registered device, and if two Uruguayan distributors want to sell the same product, each must file its own separate registration. It also says bioaccess® can act as a neutral Uruguayan Local Holder on a bespoke fee, or sequence Uruguay after another LATAM market, with pricing and timeline scoped case-by-case. Uruguay sits outside the standard bioaccess® flat-fee subscription. I am not inventing a named Uruguayan company that the trial hub does not list.
That market-access file is not a first-in-human permit and does not replace MSP/DIGESA study authorization or Decreto 158/019 ethics. If you later want to sell in Uruguay, say so at kickoff so the trial importer and any later holder role are not improvised after first implant. This article does not quote LATAM Launch subscription pricing. That SKU lives on the market-access pages, not on a first-in-human hub.
FDA use of Uruguayan 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 Uruguay studies with that FDA conversation in mind — electronic data capture, structured safety reporting, source data verification — under ISO 14155 with MSP/DIGESA authorization and ethics 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 number already on the hub
The Uruguay hub already publishes ~30% lower versus a comparable US or EU program. I am not inventing a new band here. Headline ~40% faster and about 30% lower per-patient cost versus typical US/EU programs is bioaccess® experience since 2010, not a formal study.
The hub comparison table already publishes the +1 to +2 hour offset versus the US East Coast, Decree 3/008 as the device framework, and MERCOSUR alignment. Those are operating facts, not a tourism pitch. I will not invent a Uruguay per-patient dollar band the hub does not already print.
Questions a sponsor should ask any CRO in Uruguay
- Are you running clinical trials in Uruguay now — not “historically”?
- Who owns the MSP / DIGESA clock when the file sits?
- Can you file both ethics tracks under Decreto 158/019 — the National Commission of Ethics in Research and the institutional EC — before DIGESA?
- Do you claim MSP / DIGESA is PAHO/WHO Level 4, or do you stay with what is already published?
- Do you claim to operate a named Uruguayan hospital, or do you contract sites?
- Is MSP registration a second file, or are you mixing it into the trial quote?
- 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; MSP / DIGESA and Decreto 158/019 owned as a file problem; no Level 4 invented for MSP / DIGESA; no named Uruguayan legal entity invented on this page; MSP registration kept as a separate market-access file; FDA conversation designed in from day one.
How Uruguay sits next to Colombia, Chile, 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. Chile has ISP and its own hub. Venezuela has INHRR and its own hub. Uruguay is a sibling country category. INVIMA stays INVIMA. ISP stays ISP. INHRR stays INHRR. MSP / DIGESA stays MSP / DIGESA. 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 Uruguay, clinical trials in Chile, clinical trials in Colombia, and clinical trials in Venezuela. The other new category pages in this set: CRO in Guatemala, CRO in Honduras, and CRO in Bolivia.
How to start
If you need a CRO in Uruguay / CRO en Uruguay for a first-in-human or early-feasibility device study — or you also need the separate MSP registration file — contact bioaccess® through bioaccessla.com/contact.
Bring the protocol stage, device class, and whether you also need a Uruguayan market-access file. We will tell you how the MSP / DIGESA clock would run. We will not tell you to leave the country. We will not invent a Level 4 badge, a hospital we operate, or a day-count we have not already published.
Leave a Reply