Vigilance

/Vigilance
Vigilance Emmanuel Sanchez 2018-04-11T14:30:54+00:00

VIGILANCE

EUDRAVIGILANCE registration: Sponsor, product (IMP)

Use of a validated safety data-base

Safety Plan writing and updating

Vigilance cases management during the study :

  • Reception of SAEs, alerts management
  • Control, medical evaluation and coding
  • Registration control of all pharmacovigilance cases in the e-CRF
  • Transmission to the sponsor’s pharmacovigilance department or registration in the pharmacovigilance database if managed by ITEC Services
  • Processing and declaration to the Authorities
  • Case tracking

Vigilance data review during the study :

  • Data Medical review during the study (notification review, ensuring databases consistency) and translation if required
  • Transfer of non-serious adverse events (AE and ADR) collected in the clinical database, to the sponsor pharmacovigilance service or to ITEC Services.
  • Reconciliation

Monthly report

Annual