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In an increasingly demanding regulatory environment, having a sound late-stage and post-market risk management program is paramount to product approval and commercial success. The Syneos Health® Risk and Program Management group houses our team of dedicated professionals who truly understand the complexities of late-stage risk management. We can help you work through how to optimally design, develop and implement strategic programs. 

As a part of Syneos Health Consulting, our highly motivated team approaches Program Management Office (PMO) delivery from a strategic consulting perspective, with the ability to not only develop customized risk management strategies, but also implement and execute on those strategies. This consulting philosophy means we have a strict focus on exceptional quality standards.

Whether it’s for a new product or a shared program that will include generics, we build comprehensive risk-management strategies across the following services:

 

Comprehensive Program Management

  • Governance structure and program charter
  • Team and meeting facilitation/support
  • Vendor selection, contracting and oversight
  • Program tracking and reporting
  • Financial management
  • Document management

 

Integrated REMS Solution

  • REMS design and submission preparation
  • Technology platform
  • Centralized call center
  • Educational/training materials
  • Pregnancy registry
  • REMS assessments

 

Most importantly, we diligently work to minimize friction while coordinating programs that optimize results in the shortest time. We understand the need to maximize patient access and minimize stakeholder burden, always making customer-specific needs and goals our priority.

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