On Monday, the 10th of April 2017, DataRiver was self-certified as CRO at AIFA (Contract Research Organization), in accordance with the Italian Ministry of Health Decree DM 15/11/2011.
DataRiver has implemented a Standard Operating Procedures system to document and manage collection, management and processing of clinical data throughout the whole study period. AIFA has thus attested to the compliance of processes and software platform with both ICH Guidelines for Good Clinical Practice and 21 CFR Part 11 (Electronic Records and Electronic Signature).
To get a closer look at the implemented services, click here.