Medical device trials in Colombia can start in as little as 30 days.
If a Colombian research site receives a Good Clinical Practice Certificate from INVIMA, then it is also compliant with FDA requirements for international inspections for studies involving Investigational Drugs and Biologics as well as for studies involving investigational medical devices.”
The combination of good healthcare (95% of Colombian citizens have health insurance), an already strong clinical trial industry, stringent regulations issued in 2008 that requires sites to be certified by INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) and a relatively quick and predictable approval process for launching a trial has made it a desirable clinical trial destination.
— Ronald Rosenberg, CenterWatch Weekly, April 6, 2015
Competitive costs: Savings of about 30% or more over trials costs in the US or Europe. Today’s low Colombian peso exchange rate vs the US dollar makes the country even more cost-competitive.
Fast and predictable national regulatory pathway —about 30 days for medical devices and 90 days for pharma.
High enrollment rate: A 50-million population with universal health care coverage ensures a large patient pool of all ages.
Fast product importation (free trade agreement with the U.S. and the E.U.).
Great geographical location: EST time zone, fast and direct airline connectivity from any major city.
Great healthcare infrastructure and business environment. According to América Economía magazine’s annual ranking, Colombia has the best clinics and hospitals in Latin America.