Genelife’s Medical Safety department offers, preparation, review, approval and reporting of all SAEs reported along with tailored risk-management strategies across all stages of Product Development consistent with the requirements of applicable regulatory bodies.
- AE and SAE logging, tracking, coding as per MeDRA/WHOdrug
- Safety/Medical monitoring
- Medical review of data listings
- Review of medical coding data
- Preparation of CTD Module II
- Individual case safety reports
- Expedited reporting of SAEs
- Periodic safety updates
- Safety analysis and benefit-risk evaluation
- Clinical safety reports
It provides coordination of clinical and post-marketing safety data collection, processing, and reporting.