The IT // Data Centre is a structure to support Investigator Initiated Research providing Data Management and Electronic Data Capture Solutions compliant with ECRIN Data Centre Certification requirements.
AIBILI has the ECRIN Data Centre Certification since April 2016, meeting the ECRIN requirements for IT and Data Management within clinical trials.
AIBILI Data Centre services comply with EU Directive 2001/20/EC for the implementation of GCP, Good practice for computerised systems in regulated GXP environments, PIC/S Inspectors Guide, FDA Guidance for Industry, Computerized Systems Used in clinical trials and 21 CFR Part 11, GAMP 5, ISO27000, “Requirements for Certification of ECRIN Data Centres” and ISO 9001, among others.
The IT is responsible for the management and maintenance of AIBILI Data Centre, networks and information systems. The Data Centre, built in 2014 for storing AIBILI’s critical data, houses all AIBILI servers/systems namelly: the Electronic Medical Record (EMR) that is daily used to collect patient clinical information by CEC; the custom-designed web based platform (https://studies.corc.pt/) used to exchange grading data and images by CORC; the Clinical Data Management System that is used in the development of eCRFs for each clinical trial; the PhVC Manager – Extedo that is used for pharmacovigilance in clinical trials by CHAD as well as the Clinical Trial Management System (CTMS) used for the management of multiple multinational clinical trials by 4C.