PHARMACOVIGILANCE SERVICES:
- Review of Clinical Study Protocol
- Set-up of DSMB, DSMB reports
- Set-up and maintenance of safety database, SAE handling manuals
- Medical review of SAEs and follow-up
- Medical assessment of causality and expectedness
- Expedited reports (SUSARs) to CAs and ECs/Investigators
- SAE tracking and update of SAE documentation
- Coding (MedDRA, WHO-DD, ATC)
- Generation of CIOMS-I forms and line listings
- SAE reconciliation
- Periodic Safety Reports (PSURs)