Leveraging clinical development in Latin America and Europe
Eurotrials has solid partnerships with research sites and industry professionals in Latin America and Europe, empowering the local coverage in more than 15 countries. Acting under SOPs globally implemented, Eurotrials ensures a global training structure, maintaining consistency across all regions.
Clinical Development in Latin America
For some years now, the Latin American market has been demonstrating great potential for clinical research and pharmaceutical development, mainly for its epidemiologic characteristics and the recent local governments concerns and investment.
Latin America region includes all the portuguese-spanish speaking territory from Mexico to Chile, covering 20 countries and more than 600 million people. Due to the development of several factors, like better sanitation conditions, public health system broader access, nutrition and the reduction of infant mortality, the population is living longer and with reasonable quality of life.
Conducting clinical trials in the region requires great expertise, since it comprises, for example, several different regulatory entities, legislations and a complex process of multiple applications and submissions.
It is crucial for the local partner to be comfortable with different cultures and to develop and streamline communication channels between teams, especially during start-up activities.
Clinical Development in Europe
To improve Europe attractiveness for clinical development studies, the European Commission published on 17 July 2012 a proposal for an EU Clinical Trials Regulation. This decision is key for the harmonization of clinical trials conduct in Europe, as it created a unique ground for all clinical trials applications. At the same time, it is a step forward in clinical data transparency and enhanced patient protection.
The Clinical Trials Regulation (EU-CTR) was approved on 16 April 2014 and it was published on 27 May 2014 in the Official Journal. It will start to be active after two years of the publication. The portal will be the single tool for the submission of all the information relating to clinical trials in Europe.
Europe is one of the most important regions for clinical development projects, and the birthplace for several drug discoveries.