Pharmacovigilance
Pharmacovigilance – this service allows our medical personnel to log, track, provide advice to the sponsor and report SAEs to the appropriate regulatory authorities. Medical narratives, MedDRA coding and reconciliation of the clinical database are included. It is particularly useful for new biotech companies that have no medical staff.
- Pharmacovigilance
- Receiving, processing, archiving adverse events/reaction information
- Ensure compliance with local and international requirements
- Safety reporting to Health Authorities
- Preparation of written pharmacovigilance procedures (SOPs)
- Preparation of PSUR