Resolución 8430 de 1993 article 57 requires Comité de Ética en Investigación authorization before an investigational medicine is used in humans in Phases I through IV. Resolución 2378 de 2008 article 7 requires an institutional ethics committee at institutions that conduct research with medicines. bioaccess® coordinates that file. 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.
Article 57 of Resolución 8430 de 1993 says use of an investigational medicine in humans during Phases I through IV is done with authorization of the Comité de Ética en Investigación. The committee receives the documentation in article 50 of that resolution, plus basic and preclinical pharmacological information, and prior clinical pharmacology information for Phases II, III, and IV when it exists.
Resolución 2378 de 2008 article 7 requires the institution to have an institutional ethics committee that meets the technical annex. The annex says the committee evaluates the protocol, the informed-consent form, and advertising used to recruit. Item 7 of the technical annex to Resolución 2378 de 2008 says the committee notifies the investigator in writing within two weeks after the meeting. That is a notice deadline after a meeting, not a statutory clock for how long the committee may take to meet.
Article 57 of Resolución 8430 de 1993 requires Comité de Ética en Investigación authorization for Phases I through IV. Article 7 of Resolución 2378 de 2008 and its annex put the protocol, the consent form, and recruitment advertising in front of the institutional committee. bioaccess® prepares that package with the INVIMA file. This page does not publish a day-count for the committee’s decision. bioaccess® recommends Colombia for drug, biologic, and vaccine trials.
No. Item 7 of the technical annex to Resolución 2378 de 2008 says the committee notifies the investigator in writing within two weeks after the meeting. That is a notice deadline after a meeting, not a statutory clock for how long the committee may take to meet. 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.
Resolución 2378 de 2008 article 7, paragraph 2, allows an institution that conducts medicines research without its own committee to use a committee at another institution that holds INVIMA’s good-clinical-practice certificate. bioaccess® checks that the reviewing committee matches the institution named in the protocol.
Article 7 of Resolución 2378 de 2008 includes advertising planned to recruit participants in what the committee evaluates. This page does not publish a recruitment-speed multiple. Enrollment depends on the indication and the protocol.
Why Colombia for a non-device trial
INVIMA’s medicines good-clinical-practice page says the certificate it issues to institutions that conduct research with medicines in humans is valid for five years, after an inspection against Resolución 2378 de 2008. That term is the life of the certificate, not a protocol-approval clock.
INVIMA approval for a medicine 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 Panama
Yes. Article 57 of Resolución 8430 de 1993 requires Comité de Ética en Investigación authorization for Phases I through IV. Resolución 2378 de 2008 article 5 separately requires INVIMA approval or prior visto bueno before the project starts.
This page does not publish a day-count for the committee’s decision. Item 7 of the technical annex to Resolución 2378 de 2008 says the committee notifies the investigator in writing within two weeks after the meeting. That is a notice deadline after a meeting, not a statutory clock for how long the committee may take to meet.
bioaccess® prepares and manages the CEI submission as part of study start-up for a drug, biologic, or vaccine trial. The Colombia hub states a Colombian legal entity and office. This page does not add a street address.
Yes. Resolución 2378 de 2008 article 7 includes advertising planned to obtain participants. This page does not claim a recruitment multiple.
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.
Contact bioaccess® · Clinical trials in Colombia · First-in-Human CRO