www.plurima.info
According to the GCP and ICH, "the documentation relating to a clinical trial must be retained at least two years after the last approval of a marketing application (AIC) and until there are no pending or contemplated marketing applications or at least 2 years have elapsed since formal discontinuation of clinical development of the investigational products. These documents should be retained for a longer period however if required by the applicable regulatory requirements or by an agreement with the Sponsor" (Official Gazzette N° 191 dated 18th August 1997).
Hippocrates Research & Plurima (LTA Partners) provide their technical/scientific knowledge on monitoring clinical trials and the possibility of maintaining the clinical trial documentation in several structures - on the basis of various security levels and advanced organisational methods - all over Europe.
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