Implementation Readiness
Launching a REMS program in coordination with all the other pre-launch activities can be a complex endeavor involving multiple internal functions and external vendors. Even if your product is already on the market, you cannot afford to miss something or cause delays.
REMS Coordination Office
ParagonRx offers a REMS Coordination Office (RCO) approach to operationalizing REMS programs. The RCO complements and supports internal resources with planning, project management, and the internal/external coordination that is needed to implement the elements of a REMS and assure that REMS commitments are upheld.
Project Management Services
Our experience provides proven templates, processes and insights to minimize uncertainties in REMS implementation and maximize success.
The Advantage
As a specialized resource, ParagonRx preserves independence and confidentiality throughout the process. We provide checks and balances among third-party organizations (such as call centers or registries) to mitigate legal exposure.
