Why Latin America
With the rise in the global pharmaceutical market and favorable regulatory environments since the last decade, Latin America shows great potential for conducting clinical trials.
With a population of an estimated 588 million people, the sheer size of the market cannot be overlooked. According to the U.S. National Institute of Health, 6,598 clinical trials are being conducted in Latin America, which represents 5% of all global trials.
The lack of saturation in the region, coupled with the high enrollment rates and increased regulatory development, make up some of the advantages of conducting clinical trials in the Cohortias’ network across Argentina, Brazil, Colombia and Mexico.
Main reasons to conduct a foreign clinical trial
The trend toward clinical studies conducted outside the United States, also known as foreign clinical trials (“FCTs”), is attributed to:
Drastically reduced costs
Easier subject recruitment and higher retention
Fewer regulatory hurdles
FDA acceptance of foreign clinical trials
On April 28, 2008, the Food and Drug Administration amended its regulations on the acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (“non-IND foreign clinical studies”) as support for an IND or a new drug application (NDA), or a biologics license application.
The final rule requires that such studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC) and informed consent from subjects. The GCP requirements in the final rule encompass both ethical and data integrity standards for clinical studies. This final rule, which took effect on October 27, 2008, is codified at 21 CFR 312.120. It is intended to help ensure the protection of human subjects enrolled in non-IND foreign clinical studies as well as the quality and integrity of the resulting data.