A risk evaluation and mitigation strategy (REMS) rescue

When a commercial-stage biopharmaceutical company encountered challenges with its original risk evaluation and mitigation strategy (REMS) vendor, the resulting change in implementation plans created significant risk to launch timelines and regulatory readiness. The PPD™ clinical research business of Thermo Fisher Scientific stepped in to rapidly stabilize the program, align stakeholders around a risk-based REMS strategy, and provide the regulatory, operational, and governance expertise needed to maintain momentum.

This case study explores how we stepped in, stabilized the program and kept the launch on track within an accelerated timeline.

Learn more about our risk management and REMS strategies.