Pharmacovigilance Services

Pharmacovigilance experts at IST have the necessary knowledge base to facilitate clinical research within the increasing complexity of regulatory safety requirements.

Pharmacovigilance Documents, Analyses and Medical Writing Support
  • Periodic safety update reports (PSUR, PBRER, DSUR, ASR)
  • Risk analyses for authorities
  • Safety analyses of studies and post-marketing observations
  • Safety-specific parts of study protocols, study reports and other regulatory documents containing safety information
  • Case narratives
  • Check of CRFs capturing safety information
Safety Services during Clinical Trials
  • ICSR Management:
    • Collection of AE reports originating from clinical trials or NIS
    • Case evaluation, follow up with reporters and query processes for missing information
    • Data entry and identification of duplicate cases in the safety database
    • Coding of safety information (MedDRAâ„¢)
    • Expedited electronic (E2B) or paper-based (CIOMS I / MedWatch) reporting of safety cases to competent authorities
  • Validation and analysis of AE data
  • AE-listings (CIOMS II-listings, frequency tables, etc.)
  • Data reconciliation of pharmacovigilance and clinical trial databases
  • Science reviews
  • Project-specific AE-guidelines and correspondence with investigators
  • Drug-safety-specific training and support of study managers
  • Safety surveillance and risk prevention
Post-authorization Safety Services
  • Receipt, assessment and follow-up of spontaneous reports (SADRs)
  • Analysis of international specialized literature
  • Qualified medical evaluation and assessment of reported SADRs and literature cases
  • Surveillance of risk profile
  • Risk prevention and management strategies
  • Drug safety consulting
Coding of Safety Information
  • Coding using MedDRA, ICD, and sponsor-owned thesauri
  • Code control
  • Thesaurus management
  • Development of coding conventions.