Colombia is a Major Destination for Clinical ResearchAngie Godinez
The goal is to position the country as the top destination in Latin America to conduct clinical research for the biopharma and medical device industry.
Miami, FL, May 30, 2015 – Procolombia, Colombia’s exports, tourism, investment, and country brand agency, signed an alliance in 2014 with Interventional Concepts, Inc. (ICI) —a leading clinical development firm in Miami, FL. ICI focuses in operationalizing clinical trials in Colombia for innovative MedTech startups and will collaborate with Procolombia to position Colombia as the premier destination to conduct clinical trials for innovative medical technologies and biopharma companies around the world.
Colombia, strategically located close to the US and on the same EST time zone, offers many strengths for clinical trials. It is the third-most populous country in Latin America, after Mexico and Brazil, and it’s considered the most urbanized Latin American nation. Nearly 89% of its 50 million people live in big cities; it has Good Clinical Practice guidance and over 120 sites certified to run trials. It has a centralized healthcare system that draws patients with particular needs to specialized or regional hospitals, which can help speed patient recruitment. A large number of experienced investigators working in certified sites means fewer concerns about generating high-quality data. Also, treatment-naive populations are plentiful. Strong doctor-patient relationships support high trial recruitment rates and low dropout rates. Furthermore, prices for hospital procedures in Colombia are considered to be much lower than costs in the US and Europe.
Multinational pharmaceutical companies have conducted clinical trials in Colombia for about 30 years, and it is, together with Mexico, Argentina, Brazil and Peru, one of the best destinations for clinical research. However, the majority of the country’s clinical research sites don’t have a direct contact with foreign manufacturers. The majority of research sites in Colombia are unknown to MedTech and biopharma startup companies that need to conduct early stage (phase I) trials for new medical devices and new pharmaceutical molecules.
Colombia’s greatest strengths could be its strict regulatory and site certification system. The National Food and Drug Surveillance Institute, INVIMA, has established strict requirements to ensure patient safety and quality of clinical research. INVIMA certifies each site in Good Clinical Practices quality standards and audits them randomly. Despite INVIMA’s rigor, the country bolsters one of the fastest approval and importation processes. Thanks to this initiative, the medical innovation industry will have, through ICI pre-selection process, access to over 120 INVIMA-certified research sites in Colombia.
According to an annual ranking, by América Economía magazine, Colombia leads the Latin American ranking of the best clinics and hospitals in the region and is rapidly emerging as a leader in conducting clinical trials. Based on figures from Colombia’s Ministry of Commerce, Industry and Tourism, in 2013, the country sold over $216 million in health services to foreign medical tourists. This number represents a 61% increase over the previous year. This alliance benefits Colombia mainly because it will increase its health service exports. It will also bring medical innovation to the country, and it will elevate the professional level of the physicians who are part of clinical research centers in Colombia.
From 1995 to 2013, 738 clinical trials have been conducted in Colombia. 90% of them sponsored by the pharmaceutical industry and related to chronic diseases such as cancer, cardiovascular and degenerative diseases. Colombia also has 63 INVIMA-GCP-certified institutional ethics committees. In 2012, Colombia was the sixth largest recipient of clinical research in Latin America after Brazil, Mexico, Argentina, and Chile. It contributed 9% of all the trials conducted in the region; this creates an opportunity for development and growth of its clinical research activity.
The Free Trade Agreement between Colombia and the US and the EU has allowed the country to become a very desirable commercial partner for foreign manufacturers. According to the World Bank’s Doing Business report, Colombia is among the easiest countries in which to do business. This report evaluates local regulations that affect companies in 189 countries and classify them in 10 different areas of business regulations —such as time to incorporate a company, insolvency resolution, and transborder commerce.