Planning and coordinating clinical experiments requires a very professional, computerised operational facility, where multidisciplinary figures, such as doctors, biologists, project managers, IT staff, data managers, statisticians and lawyers collaborate at top levels.
The Data Centre, with a multidisciplinary staff of more than 20 people, is the operational centre that coordinates all the Foundation’s research activities, ensuring that they comply with the international standards of best clinical practice.
GIMEMA Data Centre’s operational facility comprises four macro units: central management, planning and analysis, clinical trials management, secretariat.
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.
The Data Centre’s main activities are:
Planning and organising clinical trials, from their conception to drafting a protocol and managing the regulatory affairs and communications with Ethic committees and competent authorities.
Conducting clinical trials, coordinating member centres, managing data collection.
Pharmacovigilance, statistical analyses and publication of reports and scientific works.
Providing training courses and scientific dissemination activities.