Office of Pharmacovigilance and Monitoring for Clinical Investigations

Head

The 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
Davide
Villa
Researcher
davide.villa@marionegri.it
Wally
Calini
Researcher
wally.calini@marionegri.it
Head

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