Epidemiology & Risk Management

Services

• Strategic planning for safety & risk management
• Epidemiology & risk management consulting
• Risk minimization action plans (MAPS)
• Biopharmaceutical benefit & risk assessments
• Design & implementation of phase IV commitments
• Design & implementation of mandated safety registries
• Expanded access programs
• Post-marketing surveillance design & implementation
• Registry design & implementation
• Design & implementation of large, streamlined safety studies
• Data safety monitoring board (DSMB) services
• Regulatory strategy & submissions support