Latin America

As well as the big and populous countries of Latin America such as Argentina and Brazil, smaller countries like Columbia, Peru and Costa Rica offer vast potential for clinical trials.

Just as with other emerging regions, there are capable physicians, appropriate site facilities and access to patients; however, while there are many advantages to conducting clinical trials in Latin America, there are also some factors to bear in mind. Knowing these issues minimises the risks of running trials in the region if cultural differences and individual regulatory authorities and approval processes prove to be challenging.

There are legal demands. For example in some countries local law dictates that trial sponsors must continue to provide drugs to those in need after the trial ends. There are also expectations from patients, e.g. the informed consent process may need to address underlying issues such as religion, socio-economic issues, doctor–patient interaction, family, education and standard of care.

The Polaris team is best suited to help navigate these issues and present solutions through optimal local preferred partners that allow GCP-compliant trials to be initiated from 8 weeks of CTA to the competent authority in the individual country.