Head
Alessandro Villa
alessandro.villa@marionegri.itThe scope of the office is the coordination ofresearch projects promoted by the researchers at the Centro Daccò and the AnnaMaria Astori Centre in collaboration with other national and internationalresearch groups. Qualified Clinical Research Associates (CRA) must ensure thatclinical trials are performed following the study protocol, the Good ClinicalPractice (GCP), and the regulations in force.
Activities
- Planning and organization of the clinical trials in a methodologically correct manner.
- Risk assessment-based implementation of the monitoring plan, the study SOPs and manuals.
- Interaction with the different research players e.g., centralized laboratories to plan the study activities.
- Identification of research networks for new projects.
- Training and support for the Trial Centre(s) staff on the study protocol and SOPs.
- Supervision of study participants’ recruitment and protocol compliance
- Monitoring and validation of research data.
- Pharmacovigilance activities regarding pharmacological trials.
- Management of the investigational drug at the Trial Centre(s).
- Collaboration in the interpretation of the research data.
- Arrangement of briefings and investigator meetings for trial staff updates.
Head Unit
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Staff
Head
Alessandro Villa
alessandro.villa@marionegri.it
