The Data Centre has developed a series of internal operational procedures, in conformity with international standards of best clinical practice, guaranteeing consistency, efficiency and homogeneity of activities within the facility.
Subsequent to regular external validation processes, the Data Centre is certified UNI EN ISO 9001:2015 for the activity of «Design, conduction and management of clinical trials» and for «Organization and conduction of events and training courses».
The GIMEMA Data Centre’s reference documentation consists of SOP, Operating instructions and Quality Documents.
The Quality Manual is the principal reference document of the GIMEMA Data Centre Quality System. It contains the descriptions of the policy, organisation, responsibilities and processes implemented by the Data Centre within the scope of its expertise and activities. The purpose of the manual is to illustrate the elements underlying the entire quality system, with which to guarantee a high standard of services provided.
Since 2015 the Data Centre has been one of the 5 Clinical Trial Units certified at European level, for compliance with the strictest standards of clinical research, by the ECRIN consortium.
ISO Certificate
