phase iv Risk Management and Epidemiology

The monitoring of product safety is a key concern throughout the development cycle, but never more so than after product approval. In today’s environment, more and more drug development teams are adding post-approval activities as part of their risk management and epidemiology planning.

Risk management considerations include the number of potential users of the product, the seriousness of the disease being treated, the expected effectiveness of the product, the length of time patients will be treated, the seriousness of known or potential adverse events, and/or whether alternative agents exist. PharmaNet/i3’s Phase IV specialists advise clients to be proactive, bringing progressive, scientifically-sound risk management plans to regulatory agencies rather than facing the imposition of a mandate that may be overly restrictive.

PharmaNet/i3’s RM&E professionals develop programs to monitor and manage product utilization and safety, mitigate risk, establish a product’s risk-benefit profile, and ensure understanding of its market value.

• Post-approval safety studies
• Risk Evaluation and Mitigation Strategies (REMS) / RMPs
• Signal detection/database analyses
• Epidemiological assessments
• Label comprehension and physician compliance studies
• Restricted distribution/access programs
• Natural history studies
• Burden of illness studies
• Meta-analyses of potential safety signals during clinical trials
• Retrospective and prospective post-approval pharmacoepidemiology and drug safety studies
• Database “mining”
• Development of medication guides
• Implementation and evaluation of Elements to Ensure Safe Use (ETASU)