Risk Management

With recent legislative changes and increased regulatory focus on product safety and benefit-risk balance, PPD's clients can rely on our experience, approach and infrastructure to help them mitigate risk. We can design, develop and implement a comprehensive risk management program to address specific product safety concerns and ensure appropriate product use.

Risk Management Services

PPD's systematic approach to risk management helps increase benefits and reduces therapeutic risks. Our risk management services include:

• Risk identification and assessment
• Risk communication
• Interventions to reduce risk
• Evaluation of intervention effectiveness
• Modification of interventions when needed
• Development, implementation and evaluation of risk evaluation and mitigation strategies (REMS)

Risk Management Experience

Our recent risk management experience includes:

• Development of FDA-approved patient surveys as REMS evaluation tools
• Creation of FDA-approved methodology for implementing and coordinating patient surveys and program monitoring through the Professional Contact Center
• Formulation of REMS educational and awareness tools for patients
• Preparation of comprehensive documentation for REMS
• Development of technology integration plans for program implementation