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International Clinical Trials

Different Countries, Different Approaches

 

Since the establishment of ICH-GCP, the globalisation of clinical trials has proven to be an irreversible trend. Pharmaceutical and biotechnology companies (mainly through CROs) are increasingly testing their candidate drugs in Latin America, eastern Europe and in the Asia-Pacific region. Each of these regions is composed of many different countries, each with their own clinical research regulations.

From an operational standpoint, it is not very difficult to reconcile the differences of clinical practices around the globe, although there are particularities. The operational implementation of a clinical protocol is basically the same from one place to another, and it is possible to conduct a global multi-centric study while maintaining the quality of the generated data.

From a legal standpoint, this same globalisation scenario can be slightly different. Legal systems may have a number of similarities, but unlike the ethical and operational aspects, legal differences are harder to standardise and globalise.


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Vitor Harada is a Clinical Development professional with 11 years of experience. He graduated in Pharmacy and Biochemistry from the University of São Paulo (USP) and has a MBA from the Fundação Getulio Vargas (FGV). Vitor is currently a Director of Clinical Operations at ICON and responsible for the company’s office in Brazil. He is also President of ABRACRO (Brazilian Association of CROs) and one of the Professors/Coordinators of the Clinical Research Postgraduation Course of the Santa Casa de São Paulo Medical School. In the past, Vitor has worked for AstraZeneca (where he was the local Head of the Clinical Department), Pharmacia and Bristol-Myers Squibb.
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