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International Clinical Trials

The Latin Beat

 

The experience of running clinical trials in Latin America has improved markedly in recent years in line with the breadth of resources and expertise now available in the region. Graciela Rácaro at PAREXEL International examines the pace of evolution during the last decade

Latin America has evolved as an important area for clinical research, and the industry has shown increasing interest in the emerging region that will serve as a potential new end market for biopharmaceutical products. While clinical trial sponsors used to consider Latin America primarily in large studies or for clinical trials that could not achieve the required patient recruitment on time in ‘traditional’ research countries, more recently they have included the region from the beginning when planning their product development programmes.

Latin America has evolved as an important area for clinical research, and the industry has shown increasing interest in the emerging region that will serve as a potential new end market for biopharmaceutical products. While clinical trial sponsors used to consider Latin America primarily in large studies or for clinical trials that could not achieve the required patient recruitment on time in ‘traditional’ research countries, more recently they have included the region from the beginning when planning their product development programmes.

The growth of clinical trials in Latin America (which is linked to FDA/EMEA acceptance of foreign research data, a huge pool of potential trial patients, and the globalisation of clinical research) should be assessed not only in terms of the number of studies conducted in the region, but also through the experience gained during the last few years.


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Graciela Rácaro is Senior Director, Clinical Operations, Latin America at PAREXEL International. She is responsible for all clinical and regulatory activities in Latin America. Graciela specialises in drug development and non-clinical and clinical research. Her background includes serving as clinical lead and project manager for Latin American projects as well as global programmes. Prior to joining PAREXEL, Graciela held a clinical management position at Serono International, and previously worked at the clinical research organisation EDYABE and pharmaceutical company Laboratorio Gador, SA. Graciela holds BCh and Pharm degrees from the College of Pharmacy and Biochemistry at the University of Buenos Aires, and completed her Masters in Clinical Research and Clinical Trials Monitoring at the University Maimónides College of Medicine in Buenos Aires. Email: graciela.racaro@parexel.com

 

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