REMS Planning & Design
If you need a REMS, might need a REMS or aren't sure what you need...
Leverage our turnkey risk mitigation process.
The FDAAA, an amendment to the Food, Drug & Cosmetic Act, became law in 2007. In this Act, FDA authority and oversight of risk mitigation for NDAs and in-line products was strengthened. Today, FDA often expects NDA applicants to propose plans that mitigate safety concerns and to implement them at launch. ParagonRx has a proven process to make that happen with the right results.
REMS Strategy Development
REMS strategy development is an essential step to designing, negotiating, implementing, and assessing a REMS. It ideally begins in early development and considers the need to balance the interests of regulatory, health care provider, patient, and corporate stakeholders.
Decisions made during clinical trial planning, such as enrollment criteria and patient monitoring algorithms can have a profound impact on REMS design. Hence, these decisions should be guided by an overall strategy.
Strategic options for managing risks may range from labeling language with appropriate use support programs to effective REMS communications to patients and healthcare providers to controls and other requirements.
Collaborative REMS Design
Collaborative design entails balancing potentially competing interests to ensure regulatory acceptance, minimal disruption in the care process, support for appropriate use and optimal patient outcomes, and commercial viability of the product.
The process begins by involving key internal stakeholders to ensure that potentially competing interests (i.e., clinical, commercial, and regulatory) are all considered and reflected in the ultimate program. These internal interests also need to be balanced with those of external health care provider stakeholders, using ethnography and other methods, to help ensure that program elements are acceptable and feasible to implement.
REMS Coordination Office
ParagonRx offers a REMS Coordination Office (RCO) approach to support internal preparations, beginning with REMS planning and continuing through implementation and assessment. The RCO complements and supports internal resources with REMS planning, project management, and the internal/external coordination that is needed to design an implement the elements of a REMS and assure that REMS commitments are upheld.
The Advantage
Our proprietary risk assessment process guides the design of interventions that most effectively address key safety concerns. Program development is followed by the creation of a REMS assessment protocol to evaluate program performance.
Throughout this process, we balance potentially competing interests to ensure regulatory acceptance, minimal disruption in the care process, support for appropriate use and optimal patient outcomes, and commercial viability of the product.