The GIMEMA Data Centre structure
has four main working units:
Direction, Design and Analysis,
Clinical trials management,
Secretariat.
The main activities carried out by the Data Centre are:
- The organization and design of clinical trials.
- Protocol development for the conduction of clinical trials, from clinical hypothesis to statistical assessment.
- The management of regulatory affairs relating to the request for authorisation of the conduction of trials to Ethics Committees and Hospital Administrations.
- The conduction of clinical trials: coordination of participating centres, management and control of data coming from Centres taking part in trials.
- Translational research project management.
- Pharmacovigilance: coordination and management of all activity in connection with adverse events occurring to patients during the conduction of a clinical trial, in accordance with EU directives.
- Software development for the conduction of clinical trials.
- Statistical analysis of data collected during clinical trials.
- Publication of scientific papers in medical journals, preparation of presentations and talks at national and international conferences.
In addition to this, the Data Centre also acts as GIMEMA Foundation Secretariat, liaising with Group centres and organising meetings with researchers.
In order to manage all these processes, the Data Centre has developed a series of operating procedures, in accordance with international standards regarding good clinical practice, that ensure consistency in activities carried out within the organisation. These procedures have been validated and in 2002 the Data Centre was awarded the UNI EN ISO 9001:2000 Certificate for the "Design, conduction and management of clinical trials".
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