The ParagonRx^® Difference in Risk Management

ParagonRx^® has established itself as a recognized leader in pharmaceutical risk management. We have assembled industry-leading medical, pharmacy, regulatory, process design, and education experts, benchmarked multi-industry best practices, and published a framework that brings a new level of scientific rigor to the discipline of pharmaceutical risk management. Our services include:

• Risk Assessment — identifying potential product hazards and need for action with an evidence-based approach, RxFMEA^®, that targets specific weaknesses in the medication use process
• Program Development — engineering a system of intervention tools, designed in collaboration with end users, incorporating state-of-the-art adult learning techniques and built-in redundancies to maximize effectiveness and minimize risks
• Pretesting — using market research and predictive modeling to estimate the probability of success
• Documentation for Regulatory Submission — incorporating program description and contingency options into regulatory submissions
• Scale-Up and Tool Production — working with pharmaceutical customers to prepare their organizations for risk management program operations, or alternatively assembling the capabilities to operate the program on an outsourced basis
• Implementation with Stakeholders — using innovative approaches like scenario-based learning, experiential simulations, and practice modeling to implement effective education programs that support program adoption
• Measurement and Reporting — assuring that interventions and effectiveness of the program are quantified in a way that is consistent with regulatory reporting and ongoing quality improvement
• Improvement — using continuous quality improvement principles to enhance the performance of the risk management program to achieve goals

In order to help companies prepare for changing regulatory requirements, ParagonRx^® also offers consulting services to support organizational preparedness, organizational structure, and the establishment of new processes and procedures.

A Culture of Confidentiality