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
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
- 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
- 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 using MedDRA, ICD, and sponsor-owned thesauri
- Code control
- Thesaurus management
- Development of coding conventions.