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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:
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.
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.
Latin America spans across two hemispheres and consists of over 21 countries. It has a population of over 569 million, yet only two official languages are spoken there. Spanish is the official Language for all Latin American countries except for Brazil, whose official language is Portuguese. This allows sponsors significant translation cost and time saving advantages compared to running multinational studies with comparable populations such as Europe. While most investigators are able to speak English, all regulatory documents must be in the native language. It is estimated that 77 per cent of the total Latin American population are concentrated in urban areas. The five largest metro areas in Latin America Mexico City, Sao Paulo, Buenos Aires, Santiago and Bogota have a combined population of over 58 million people. These population densities can offer sponsors great advantages for patient recruitment and trial Logistics because fewer sites are necessary to achieve target patient populations.
The continent is comprised of the following speakers and languages:
Please contact us with an outline of your requirements, if you are looking for clinical trial translation services. Our team will be happy to provide you with a competitive quote and start a new professional business relationship.