- Ipsum Clinical and Fundación Salud para el Trópico (Tropical Health Foundation) were awarded GCP certification by INVIMA for its clinical research center located in the village Calabazo in the Sierra Nevada of Santa Marta.
- Certification in GCP is a requirement for conducting clinical trials in Colombia. Having a unique center like this increases the ability of Colombia to improve access to the benefits of experimental tropical disease therapy.
Calabazo, Sierra Nevada of Santa Marta, October 28, 2016.
The Tropical Health Foundation is located in Reserva Natural Kalashe (Natural Reserve of Kalashe), 10 Km away from the city of Santa Marta. Tropical Health Foundation (FSPT), is a private non-profit profit scientific, technical and social group that seeks to improve the quality of life of communities in the tropics through social appropriation of knowledge, planning and biodiversity.
Ipsum Clinical and Tropical Health Foundation recently achieved GCP certification by INVIMA at its center in Calabazo. This certification is required to conduct clinical trials in Colombia.
A clinical trial is a study that evaluates new drugs, vaccines and medical devices in humans to get approval for use in the general population.
“Having this site in the Sierra Nevada is a unique opportunity for the competitivity of clinical research in Colombia and to improve the access of communities living in remote areas to experimental drugs and vaccines.” Laureano Mestra, MD, Chief Medical Officer, Ipsum Clinical.
This new center, due to its geographical location, is the first center of its type immersed in a rural area in Colombia. “Now we can increase the Foundation’s impact over the Sierra Nevada communities and attract more interest from entities working in poverty diseases.” Juan Carlos Dib Diaz Granados, MD, PhD, Director, Fundación Salud para el Trópico.
Ipsum Clinical and FSPT are preparing to start the first study in this center, evaluating a drug for Chagas disease in children. Chagas disease is a disease caused by Trypanosoma cruzi, a parasite that is transmitted primarily through the bite of an insect. An estimated 6-8 million people around the world are infected and between 65-100 million are at risk of becoming infected.
Chagas disease is a parasitic disease of highest impact on the Americas. Chagas however, remains largely unknown and without treatment causes significant chronic health issues.
For this study, under the strictest ethical guidelines, the center is working with children of Kogi and Wiwa communities that are affected by the ravages of this sickness.
The direct benefit is enormous since the effectiveness of this drug that has been needed for many years in it’s pediatric form, will finally be tested in Colombian communities heavily affected by this terrible disease.
Founded in the United States and based in Colombia in the Ruta N innovation hub in Medellin, Ipsum seeks to boost clinical research in Colombia under the pillars of capacity building, the empowerment of local resource and innovation.
Ipsum Clinical is in the process of building several clinical research centers in cities across Colombia and is attracting new initiatives to generate not only economic but social impact in the context of medical research.
- Alvarez-Hernandez DA et al. Chagas disease: Current perspectives on a forgotten disease. Medical Journal of General Hospital of Mexico.
- Tarleton RL. Chagas Disease: A Solvable Problem, Ignored. Trends Mol Med. 2016 Oct; 22 (10): 835-838.