Kendle’s recent acquisition of IC-Research augments our access to the Colombian market, building on our strong base of operations in Mexico and Peru and new operations in Chile, Argentina and Brazil.
Although Colombia’s clinical research activity has increased considerably over the past years, there are relatively fewer competing studies here compared to other regions of the world. Our new office in the capital city of Bogotá further strengthens Kendle’s global clinical development capabilities in the Phase II-IV arena.
Strong patient recruitment and retention potential
With 43.5 million people – of which 78 percent live in urban centers and eight million live in Bogotá – Colombia has one the largest populations in South America. Most patients have not participated in a clinical trial and many diseases eradicated in the United States and Europe still exist in Colombia. In addition, at least 32 percent of the population is aged 14 years or younger, so the potential for pediatric recruitment is high also. Furthermore, as a country without defined seasons due to its equatorial geography, Colombia offers great potential to test drugs for seasonally-induced diseases year-round.
Well-established regulatory process
Colombia has a well-established regulatory process based on ICH GCP. Ethics Committee and Ministry of Health (MoH) approval takes 13-17 weeks, including the drug import license process. Since 2004, the FDA has been inspecting clinical trials conducted in Colombia, with positive results.
