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Regulations concerning clinical trials with drug products

20-11-2016
Regulations concerning clinical trials with drug products
This regulation includes the European Directive approved in April 2014,  but that did not enter into effect until May 2016. It examines how to speed up the processing, and therefore the bureaucracy, of clinical trials, as well as simplify procedures without undermining the guarantees for clinical trial participants. On the other hand, the clinical trial proposal of the Royal Decree also includes a few possible improvements to the authorization procedure for clinical trials at the State level, which would modify Royal Decree 223/2004, of 6 February, regulating clinical trials with drugs. 

At BioClever, as an independent CRO specialized in the  clinical trial industry, we are undergo ongoing training to be up to date with regulations so as to continue offering our services with all the guarantees and in compliance with all national and international regulations concerning clinical trials, and thus continue to offer our clients an efficient, top-quality service. 

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