Clinical and Pharmacovigilance Compliance

Clinical Research and Pharmacovigilance activities are critical to ensuring patient safety and understanding of product benefits and risks. All such activities are performed within highly controlled and regulated “systems”. Our team is well versed in the global regulatory requirements for both of these areas and works with clients to build and to verify the robustness of compliant systems.

Services range from performing a “diagnostic” review of a PV system or Clinical Research program to providing input on development and resolution of corrective and preventive action plans to full auditing.

  • Designing a risk-based and robust audit program that meets expectations of global health authorities (including European GVP Modules I and IV)
  • Performing audits of PV systems or Clinical Research programs to ensure compliance with Good Pharmacovigilance Practices (GVP) or Good Clinical Practices (GCP)
  • Perform a PV system or Clinical Program “diagnostic” review to identify gaps in the system that are likely to result in negative inspection findings
  • Assist with development and execution of robust action plans to close gaps, including documentation to support plans in the event of an inspection
  • Inspection Preparation
    • Prepare list of inspection topics likely to be reviewed
    • Work with client process owners or subject matter experts to determine challenging areas within PV Compliance topics of interest
    • Develop appropriate responses to likely questions to be asked or areas to be probed
    • Perform mock inspection interviews to prepare the client team to respond to a likely inspection scenario
  • Support clients at the time of inspection by managing the inspection operation, or “control room”
  • Assist clients with review and understanding of inspection reports and in assigning owners to topics (with appropriate stakeholder buy-in
  • Support development of effective corrective and preventive action plans (CAPA) that will satisfy both business and regulatory expectations
  • Support action planning around CAPA and execution of plans
  • Conduct evidence review to ensure CAPA related activities have been completed