Phase I in Resolución 8430 de 1993 article 54(a) is the first administration of an investigational medicine to a human. Article 53 includes biological products for human use. A medical device first-in-human, early feasibility, or pivotal study is led from Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. 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 54(a) defines Phase I as the first administration of an investigational medicine to a healthy human, in single or multiple doses, in small hospitalized groups, to establish initial pharmacological parameters. Article 58 limits Phase I of new antineoplastic medicines, and of other medicines with a very narrow therapeutic index, to volunteers who already have the specific disease. Article 55 requires a complete preclinical package — physicochemical characteristics, pharmacology, toxicity, pharmacokinetics, and mutagenesis, teratogenesis, and carcinogenesis studies — before that clinical research.
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. Foreign drug and biologic data can be eligible for FDA submission and review under 21 CFR 312.120 when that rule’s conditions are met. Eligibility is not approval.
Yes. Article 54(a) defines Phase I as the first administration of an investigational medicine to a healthy human, in single or multiple doses, in small hospitalized groups, to establish initial pharmacological parameters. Article 58 limits Phase I of new antineoplastic medicines, and of other medicines with a very narrow therapeutic index, to volunteers who already have the specific disease. Article 55 requires a complete preclinical package — physicochemical characteristics, pharmacology, toxicity, pharmacokinetics, and mutagenesis, teratogenesis, and carcinogenesis studies — before that clinical research. 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. bioaccess® recommends Colombia for drug, biologic, and vaccine 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. This spoke covers Phase I drug and biologic research under Resolución 8430 de 1993. It does not place a device study here. The cross-country device pages are the First-in-Human CRO page and the early feasibility studies page.
Article 54(a) describes Phase I in healthy humans. Article 58 does not allow that healthy-volunteer design for new antineoplastic medicines or for other medicines with a very narrow therapeutic index. Those Phase I studies are limited to volunteers with the specific disease, when preclinical work shows activity and toxicity and no available treatment has worked. bioaccess® reads the protocol against that exception before anyone is enrolled.
INVIMA approval for a medicine trial
Article 53 expressly includes biological products for human use in pharmacological research. A vaccine or other biologic that falls in that definition uses the Phase I–IV sequence, the article 57 ethics authorization, and the Resolución 2378 article 5 INVIMA gate. This page does not add a second statute for vaccines.
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. Costa Rica’s first-in-human page is one of those five. This Colombia URL does not replace it.
First-in-human trials in Costa Rica
Foreign drug and biologic data can be eligible for FDA submission and review under 21 CFR 312.120 when that rule’s conditions are met. Eligibility is not approval. Device data under 21 CFR 812.28 applies when that device study runs in one of the five lead countries. It does not move the device study onto this page.
Article 54(a) of Resolución 8430 de 1993: the first administration of an investigational medicine to a healthy human, in small hospitalized groups, to establish initial pharmacological parameters. Article 58 changes that population for new antineoplastics and for medicines with a very narrow therapeutic index.
Yes. Article 55 says every clinical pharmacology investigation is preceded by complete preclinical studies, including toxicology and mutagenesis, teratogenesis, and carcinogenesis studies. Article 56 ties the toxicology package to the drug and to the route and duration proposed in humans.
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 cross-country pages are the First-in-Human CRO page, the early feasibility studies page, and the first-in-human clinical trials guide.
Foreign drug and biologic data can be eligible for FDA submission and review under 21 CFR 312.120 when that rule’s conditions are met. Eligibility is not approval.
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