Pharmacovigilance in Clinical Trials

 

Therapeutic Area Experience
Focus on NIS
Regulatory Trials
e-CRF
QA Activities
Medical Writing
Phv in Clinical Trials

All the Pre-Marketing Pharmacovigilance activities are coordinated and supervisioned by the Clinical Operations Manager and by Drug Safety Coordinators.

Clinical Trial Adverse Events / Adverse Device Effects

Reporting according to GB Pharma Services specific SOPs based on Directive 2001/20/EC (interventional trials), or Directive 2001/83/CE (NIS) and following updates, or based on ISO14155 (medical devices).

Adverse events and safety reports management

  • Receipt and registration of AEs / SAEs
  • Evaluation of “Seriousness”, “Expectedness” and “Relatedness” by Drug Safety Officers and Medical Advisor
  • Follow up requests
  • Central Triage in Safety DB
  • Data Entry
  • MedDRA coding
  • Quality Control
  • “Narrative” preparation
  • Medical review evaluation
  • Final Assessment
  • Safety and Clinical DB “reconciliation”
  • Preparation of DSUR

SUSAR Management

  • Generation of XML file for Eudravigilance
  • Management of EV messages
  • Preparation and notification to CA / EC
  • Preparation and notification to Investigators
  • Notification to Sponsor
  • Notification tracking