Services
Pharmacovigilance
We offer a comprehensive solution for PV services, including a validated database that is configured and managed internally for timely deployment. Our scalable platform allows for a streamlined approach to collect, manage, analyze, and report patient safety events (SAEs) and adverse events of special interest (AESIs). Having a dedicated PV provider promotes consistency and standardization across your studies while reducing operational complexities and costs.
Our services include:
- Development of Safety Management Plans
- Case intake, processing, and notification
- Query management
- Narrative writing
- Medical review and coding
- Clinical database reconciliation and QC
- Regulatory formats and standards for FDA / EMA reporting
- Other reports to support IND, DSUR, PSUR, DSMB meetings, and more