Brazil is one of only two Latin American countries (besides Argentina) to have its own contract research organization (CRO) association, and one of only a handful of countries on Earth to do so. That alone speaks volumes about the maturity and size of its clinical research market. Launched in 2006, the Brazilian association is called Associação Brasileira de CROs (or “Abracro”) and naturally most of its energy has been focused on simplifying the country’s labyrinthian regulatory environment. Last year and this year, Abracro and other stakeholders in the industry worked with the government to try to change the clunky approvals process, lest Brazil’s slow start-up times hobble the clinical research market that has grown robustly there over the past 12 years. In the summer, victory. Agência Nacional de Vigilância Sanitária (known as Anvisa), the Brazilian FDA, agreed to let sponsors and CROs seek various approvals simultaneously instead of sequentially. When that…more...