Working for you in Latin America

Latin America is globally recognized for its enrollment potential and the high quality of study data obtained. In addition, regulatory enforcement bodies, quality investigators, ethics committees ensuring patient safety, proactive Good Clinical Practice (GCP) policy development, and large research naïve populations have been cited as contributing to the explosive growth of clinical trial management in this region.

For example, the number of clinical trials started in Brazil increased 58% (from 153 in 2005, to 241 by 2009). In Argentina the growth in new trial starts was more modest at 16% (from 97 to 112 over the same period), while Mexico achieved a 49% increase in new trial starts (from 106 to 158 over the same period). 

Source: clinicaltrial.gov

Ensuring the success of Latin American trials

Successful clinical trials rely on a variety of factors, including:

Navigating regulatory challenges in Latin America

Latin American countries have become desirable sites for studies both because they have adopted regulations that mirror those recommended by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and because the regulatory authorities are committed to keeping them updated.

In Brazil, the National Committee for Ethics in Research (CONEP) provides the main ethical approval for clinical trials with foreign cooperation. The designated lead research site submits the study protocol and informed consent to CONEP. In parallel, the sponsor submits the trial for review and approval by the Ministry of Health.

Argentina also requires that a study must obtain institutional approval and approval from the local representatives of the Ministry of Health. In Chile, only IRB approval is required. While the Ministry of Health does not have to approve the study, they do acknowledge the study and issue the import license for drugs connected with the trial.

Best practices lead to better outcomes

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