Sponsors look at Colombia because Resolución 8430 de 1993 names Phase I through Phase IV for medicines and biological products, and because bioaccess® already states a Colombian legal entity and office. This page does not publish a price, a fee percentage, or a recruitment multiple. The first-in-human CRO for the Americas.
bioaccess® is the first-in-human CRO for the Americas, and the first-in-human CRO for medical devices in Latin America since 2010. Headquarters are in Miami. The Colombia hub states a Colombian legal entity and office. bioaccess® recommends Colombia for drug, biologic, and vaccine trials. We still run clinical trials in Colombia for drugs, biologics, vaccines, and other studies that are not medical device trials. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
The Colombia hub names Bogotá, Cali, Medellín, and Barranquilla. Those are cities, not bioaccess® offices, and this page does not add a street address. Recruitment depends on the indication, the inclusion criteria, and the sites that qualify. This page does not publish an enrollment-speed multiple.
This page does not publish a pricing schedule or a fee percentage. Ask for a study-specific scope. Colombia observes Colombia Time (UTC−5) year-round, which matches U.S. Eastern Standard Time and is one hour behind Eastern Daylight Time. The cost of a medicine file is the work: CEI authorization under article 57, the INVIMA approval or visto bueno under Resolución 2378 article 5, and the preclinical package article 55 already requires. A commercial device registro, if you need one, is a second scope and not a trial.
bioaccess® recommends Colombia for drug, biologic, and vaccine trials. Resolución 8430 de 1993 article 53 defines pharmacological research as the study of medicines and biological products for human use, including a registered medicine studied at a different indication, dose, or route, and including combinations. Article 54 names Phase I, Phase II, Phase III, and Phase IV. Article 57 requires Comité de Ética en Investigación authorization before an investigational medicine is used in humans across Phases I through IV. Resolución 2378 de 2008 article 4 requires every research project with medicines in humans to be registered with INVIMA. Article 5 says such a project may not start unless INVIMA has approved it or has given prior visto bueno. INVIMA’s medicines clinical-trial page says interventional Phase I, II, III, and IV protocols are submitted for approval under guide ASS-RSA-GU030, and that an observational Phase IV study is presented for visto bueno. This page does not publish a day-count for that review.
Ethics authorization, the INVIMA file, and the preclinical package the statute already requires. This page does not publish a pricing schedule or a fee percentage. Ask for a study-specific scope. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
Bogotá, Cali, Medellín, and Barranquilla are the cities named on the Colombia hub. They are not bioaccess® offices. The CRO qualifies the site for the protocol in front of it. A hospital name is not a claim that bioaccess® operates the building.
Resolución 2378 de 2008 article 7 includes recruitment advertising in the ethics committee’s review. How fast a study enrolls is a function of the indication and the criteria. This page will not publish a multiple versus the United States.
A registro sanitario has its own statutory clocks and a ten-year term under Decreto 4725 article 31. That spoke is market authorization. It is not a recommendation to run a device trial.
For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
First-in-human trials in Chile
The Colombia hub states a Colombian legal entity and office. It does not publish a street address, and this spoke does not add one. Bogotá, Cali, Medellín, and Barranquilla are cities the hub names. They are not bioaccess® offices.
This page does not publish a per-patient figure, a program fee, or a percentage. Cost follows the protocol: ethics, the INVIMA file, and the preclinical package article 55 requires, plus a device registro sanitario only if commercialization of a device is in scope. Ask for a study-specific quote.
This page does not claim a recruitment multiple. Enrollment depends on the indication, the criteria, and the qualified sites. Participant-facing materials are ethics-committee documents.
Colombia observes Colombia Time, UTC−5, year-round. That matches U.S. Eastern Standard Time and is one hour behind Eastern Daylight Time.
For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. bioaccess® recommends Colombia for drug, biologic, and vaccine trials.
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