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