The trial management activity includes the activation of the clinical centres, coordination and support to all the functions in the clinical studies, the planning of the monitoring activities, of the Investigator meetings and of the study team meetings. The monitoring activities consist in the supervision of the trend of the clinical study in order to guarantee that the study is conducted, recorded and reported in compliance with the protocol, the Standard Operative Procedures (SOP) and the Good Clinical Practice (GCP). In particular, such activities include the monitoring visits as well as the redaction of the reports (qualification, initiation, monitoring, close-out).
The drug management activities consist in the coordination of the logistic processes of the IMP involved in the clinical trials, support the clinical Centres in the processes of storage, utilization and destruction of the IMP, in accordance with the protocol, the SOP and the GCP.
Management of data archives collected during clinical trial and clinical databases by means of specific controls intended to guarantee the reliability of the data and the respect of the information security, include: CRF design; preparation of the Data Management Plan; encoding of the medical terms by means of international dictionaries (MedDRA and WHO-DDE); management of inconsistencies emerged with the consistency check and plausibility of the collected data, database lock and data release for statistical analysis.