Posts tagged clinical trials
Frequently Asked Questions About Medical Device First-in-Human Clinical Trials in Colombia

We can assist you with the search, site selection, and approval of planned first-in-human clinical trial in Colombia. We will review your site selection criteria and study goals. Then, we will search the 110+ clinical research sites in Colombia that are ICH-GCP (certified by Colombia's regulatory agency, INVIMA) to find the ideal site and principal investigator for your clinical trial. We will then get the study approved at the site's ethics committee, and then we will get it approved at INVIMA. The next step is to obtain an import permit approved so that you can ship your investigational medical products to your site in Colombia. Please be aware Colombian regulations prevent healthy volunteers from participating in Phase I trials; only sick patients with the disease related to the therapeutic area of your investigational products are allowed.

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