Benefit-Risk Evaluation

Care Process Mapping

What is Care Process Mapping?

Care Process Mapping is the visual representation of the flow of activities observed when shadowing clinicians in their practice (see Ethnography). This depiction, referred to as a CareMap™, helps identify weaknesses in the care process that may expose patients to risks and develop targeted interventions to mitigate those risks.

When would I need Care Process Mapping?

Care Process Mapping should be considered as part of an overall product risk assessment and risk management planning, particularly in the following situations:
  • Products with a risk currently not routinely managed by the targeted prescribers
  • Products requiring additional safety monitoring or other activities outside of the current standard of care (e.g., more frequent monitoring or a need to monitor a parameter not routinely monitored)
  • Products for a disease state requiring coordination among various stakeholders and specialties
  • Products that will be prescribed by different physician specialties
  • Therapeutic areas where the care process may not be fully understood or where there are currently no treatment options

What are the benefits of Care Process Mapping?

Care Process Mapping and the creation of a CareMap provides a visual tool that helps identify where activities take place in the care process, their associated stakeholders, and the points of weakness that may expose patients to the risks. When used in conjunction with a systematic risk assessment methodology, Care Process Mapping provides a robust foundation to the design, development, and implementation of targeted risk mitigation tools and materials that can easily be integrated into practice.

What makes ParagonRx Care Process Mapping unique?

ParagonRx uses a systematic risk assessment methodology to design and develop risk management programs. This approach in conjunction with real world insights from ethnography and Care Process Mapping, allows for the development of well-designed risk management programs that are well integrated into clinical practice and defensible to regulatory authorities.