Why Colombia is the best country for innovative pharma, medtech & biotech startups to conduct their clinical trials
Colombia — with a population of 50 millions— offers fast regulatory approval, ample access to patients, and great cost savings.
Colombia is the top destination for any medical device or biopharma company that is looking to conduct cost effective…www.haikudeck.com
Development-stage pharma, medtech & biotech startups struggle to find highly talented medical staff that will give them the focus and energy to complete, on a timely manner, quality, and ethical clinical research at a very competitive cost. Colombia has set an aggressive 2025 goal to become one of the top three science, technology and innovation countries in Latin America, and for that it has partnered with the World Bank on a $41.5 million project to promote human capital for the knowledge economy, R&D and innovation. INVIMA, the national regulatory agency for clinical research, is making the right changes to streamline its processes and become more internationally competitive.
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
The country of Colombia (South America), with a population of almost 50 million, has over 120 government-GCP-certified clinical research sites. These sites have been conducting trials for almost 30 years, have very little international exposure and are unknown to the pharma, medtech & biotech industry around the world. These are highly qualified sites that receive about 100 annual trials sponsored mainly by the local Colombian subsidiaries of multinational pharmaceutical companies (e.g. Johnson & Johnson, Novartis, Roche, Pfizer, Sanofi, Merck, etc.). These sites are staffed by experienced and highly trained personnel and can be made available to the pharma, medtech & biotech industry around the world.
On April 6, 2015, CenterWatch, the leading clinical research publication, featured a front-page article about how Colombia is attracting innovative medical technology startups to the country.
Colombia, as a top destination for pharma, medtech & biotech clinical trials, has been featured on the Biodesign site — which is the companion to the 2nd edition of Biodesign: The Process of Innovating Medical Technologies — the most important medical innovation book in the medical device development industry. The “Update” section and the Strategy Development/Clinical Strategy chapter are profiling our work to make Colombia the top choice for early-stage clinical trials. This book was inspired by the world-renowned Stanford University’s Biodesign program and was written by Paul Yock, MD, director of Biodesign, and one of the most respected authorities in the industry and other collaborators. Read more.
Colombia: from failed state to Latin American powerhouse. In the shadow of a violent and drug-fuelled past, business confidence is growing in Colombia, a country that has been transformed over the past decade.
— The Telegraph, February 28, 2015
Colombia has a robust clinical research industry ready to help pharma, medtech & biotech startups
Colombian medicine is well-known in Latin America and the rest of the world as a pioneer and leader in health services, positioning the country as one of the most attractive destinations for medical tourism. In fact, Colombia has been working for many years towards consolidation and excellence in health services, offering a highly competitive environment with prominent strengths. According to the annual ranking of América Economía magazine, Colombia has the best hospitals in Latin America and has the largest share (42%) of the best hospitals in the region. Furthermore, the World Health Organization has ranked Colombia’s health system ranks as the first in Latin America.
In 2013, Colombia exported $215 million in health services and almost 50,000 foreign patients traveled to Colombia seeking medical services; by 2032, this amount is expected to increase to $6 billion. Thanks to the alliances between the Government, private enterprises, experts and scientists, as well as through positive administrative and managerial changes, a great portfolio of medical and surgical services has been developed to provide patients with world-class, high-quality services. Learn more at the Colombian health portal. Several clinical research organizations in Latin America have reported annual growth of about 35% to 50%. It’s expected that in the next few years, Latin America will double its current volume of over 4,500 trials. Clinical trials in Colombia have been conducted since the early 80s; today it receives about 100 annual clinical trials.
When it comes to launching early clinical trials for medical devices, the three leading Latin American countries are Colombia, Paraguay and Chile…Colombia also is relatively close to the East Coast with short flights, has a stable government and is the only country trying to attract startups and small companies for phase I. It is harder and more costly to do early stage trials in the U.S., and Colombia hospitals and some doctors have close relationships with the University of Miami Medical School, a teaching hospital.
— Jonathan Rourke, CEO & co-founder, Mitraspan, Inc., CenterWatch Weekly, April 6, 2015
The Ministry of Health and Social Protection of the Republic of Colombia mandated INVIMA to issue the Good Clinical Practice Certificate to clinical research sites in Colombia that comply with its strict guidelines. The law includes a comprehensive checklist that every site must complete. INVIMA then visits every site that applies for the certificate, verifies its compliance with the resolution´s checklist and grants a GCP certificate. With respect to whether the INVIMA Good Clinical Practices Certificate is compliant with FDA requirements, for international inspections of pharmaceutical trials, the FDA requires conducting the trials according to GCP and under the Ethics Committee approval. The FDA requires conducting a trial according to the Declaration of Helsinki (a requirement in Resolution 2378) and to the laws and regulations of the country where the trial is taking place.
It therefore follows that 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. Read more.
Unparalleled benefits for a pharma, medtech or biotech startup to conduct its next clinical trial.
- High enrollment rate, competitive costs, highly motivated and bilingual investigators, and a fast and predictable national regulatory pathway — about 30 days for medical devices and 90 days for pharma.
- Colombia is a Latin-American leader in volume of clinical research and receives about 100 annual trials.
- Great healthcare infrastructure and business environment. According to the annual ranking of América Economía magazine, Colombia has the best hospitals in Latin America and has the largest share (+40%) of the best hospitals in the region.
- A 50-million population with universal health care coverage ensures a large patient pool of all ages.
- Over 120 ICH/GCP-government-certified research sites with almost 30 years of experience and with the same quality and ethical standards that you would find in the U.S. and Europe.
- 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.
- Latin America’s highest ranking on the ease of doing business, at 34 among 189 economies worldwide (see 2015 World Bank report).