Post-marketing Maintenance
Our highly trained pharmacovigilance (PV) professionals specialize in the management of post marketing Adverse Events (AEs) and Adverse Device Events (ADEs), and you can rely on us to undertake any PV task relating to compliance with FDA, EMA and ICH regulations for drug safety and PV. We are also able to provide Medical Oversight Services (Chief Medical Officer).
Our extensive portfolio of services includes:
- Comprehensive case management
- Data entry, narrative generation and quality control
- MedDRA Coding of adverse events (including regular up-versioning)
- Follow-up on information inquiries
- MedWatch/CIOMS report generation
- Medical Review (including MedDRA coding reviews and trend analysis) by PV trained physicians
- Expedited reporting in the US and EU
- Follow up case processing and case closure
- Periodic safety reports
- Reconciliation of Adverse Events with business partners and the Quality Assurance group
- Review of Global Safety Agreements
- Literature reviews
- Risk management
Our specialized PV services include:
- Periodic Safety Reports
- Special issue work-up
- Integrated safety summaries
- Company core data sheet generation and maintenances
- Safety and Surveillance Programs for investigational and marketed products
- Risk mitigation and management plans
- Risk evaluation and mitigation programs (REMS)
- Quality control systems for off-shored PV services
- Mock safety audits
- Audit Periodic Safety Reports to the FDA
- Audit preparation
- Data review, coding and narrative review, plus document verification on Adverse Event case reports
- Placement of trained PV specialists at client companies