CLINICAL RESEARCH

Clinical trials are now very much international. With the global clinical landscape changing and many clinical trials being conducted in regions other than the notoriously expensive European and American regions, Clinical Research Organisations are increasingly looking to conduct clinical trials in lower cost, less saturated parts of the world

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

• Willing target population
• Investigational teams
• Epidemiologic considerations
• Health systems
• Standard of care

Challenges

One of the major barriers to completing a successful clinical trail in Latin America, as well as in other regions, is to overcome linguistic and cultural barriers. At Latin Link we are experts in facilitating the translation of clinical documents as well as understanding the linguistic and scientific requirements for each region.

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.

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.