Clinical Safety Services
- Clinical SAE Processing & Expedited Reporting
- Medical Review of SAE
- Medical Monitoring
- Signal Detection & Signal Management
- Development Safety Update Report (DSUR)
- Reconciliation with Partners, Clinical Database
- Responsible Person for Pharmacovigilance (RPPV)
- CSR Narratives
- Investigator Brochure
- Global and Local Medical Literature Monitoring
- Pharmacovigilance SOPs and Safety System Setup & Maintenance, PSMF, Audits & Inspections