Strategy
Assess Pharmacovigilance Efforts and Develop Right-Sized Vision, Strategy, and Approach for Clients
- Lifecycle PV Strategy
- Risk Profile Definition
- Risk Management Planning
- Due Diligence
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Implementation
Develop and Implement Integrated Pharmacovigilance System Focused on Process, People, Technology, Compliance, Science
- Communication and Change Management
- Process Mapping and Integration
- SOP Development
- Document Hierarchy Design
- Organizational Design
- Metrics that Matter
- Technology Selection and Adoption
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Operations
Set Up and Operate Outsourced PV Projects/Functions or Entire Departments on Behalf of Clients
- Clinical Trial AE Handling and Reporting
- Post-Marketing ADR Handling and Reporting
- Medical Reviews, Medical Writing
- Expert Statements, Investigator Notifications
- Aggregate Reporting
- Call Center and Helpline
- Qualified Person
- Medical Information
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