Brazil has many well-qualified investigators and more are being trained each day thanks to the efforts of CYNC. Relationships with well-trained clinical investigators are a primary key element in quality research. Our investigator database is growing only with professionals who are dedicated to the quality of clinical research.

Brazil’s regulatory framework is very modernized with newly implemented systems of submission, review, approval and maintenance. All clinical trials in Brazil follow ICH and GCP guidelines as required by Brazilian law. All data generated from Brazilian trials is valid for marketing requests as per Title 21 Section 312.120 and 314.106 of the Code of Federal Regulations.

Another advantage of Brazilian clinical trials is less competition for subjects with specific conditions. It’s fact that the drug developers have to seek more innovative solutions for R&D while at the same time addressing the small picture issues like cutting clinical research costs. While the surge in R&D has provided many new compounds to develop preliminarily, new IND submissions to the FDA have steadily decreased. This alone significantly increases the long-term economic burden of drug development.

Clinical trials offer an attractive opportunity to research subjects in Brazilian communities, who might not otherwise have pursued medical attention. The willingness and availability of subjects in Brazil is a positive factor for recruitment. Having data from patients of different ethnic and genetics backgrounds is becoming standard during the development of new pharmaceuticals.