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

ICH E2B
Compliant

21 CFR

Part 11 Compliant

EDC

compatible

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We provide ballpark costs for your clinical development planning