ParagonRx® | Minimize Risk and Optimize Use

Blogs

We have built the ParagonRx blog in an effort to keep you up to date with what is happening in the world of pharmaceutical risk management, REMS, and optimal product use.

Latest Posts:

• Ethnographic Research and REMS
  -Guest Blog by Andrea J. Simon, PhD.- In the past year, pressures to integrate observational or ethnographic research (which really are one and the same) in pharmaceutical and biotech industries are increasing as the value of this research is becoming better understood. In particular, Phase IV research involving the management and use of a drug protocol [...]
• REMS Assessments: Designing and Evaluating REMS
  Sponsors are struggling with how to adapt research survey methods to meet the regulatory reporting standards of REMS assessments.  Assessments need to be designed in a way that measure risk mitigation.  Reports and interpretation of findings are highly qualitative and declarations of success may be inconsistent with those findings. REMS assessments should be designed in a [...]