Our Approach
Addressing Your Needs
While no one on your team denies the importance of risk mitigation and facilitating appropriate use of your products, it is very difficult to get your "day job" done and also spearhead long-term, complex programs. A manufacturer-designed program may be misconstrued as a sales tactic by FDA and clinicians.
Risk mitigation discussions can often elucidate sharply diverging interests both within your company at internal meetings and with a CRO vendor who helped acquire your clinical data and now attempts to provide objective counsel on the risk that these data represent. And some vendors have an agenda of selling additional technologies and systems that are inconsistent with your interest in a simple, implementable and effective program.
Since 2001, the professionals at ParagonRx have worked daily with cross-functional teams worldwide to bridge medical and marketing perspectives. We help obtain and document the necessary consensus for every step. Then we prepare deliverables for team review, explaining options, contingencies, and continuously integrating all that your team has learned about your compound or device. Synthesizing our collective findings into effective strategies and tools for appropriate use is what we are best at.
Many service providers and consultants are now recognizing the importance of risk mitigation. Key criteria we suggest for evaluating potential partners include:
- Experience designing risk management programs for several brands, to offer the benefit of significant cross-product best practices
- Staff expertise that has been recognized, invited and published
- Validated evidence-based methods (such as FMEA) to reliably develop programs
- Processes for collaboratively designing interventions with clinicians and other end-users
- Separation of program design from post-launch operations to avoid bias concerns
- Documented process to balance clinical, financial and regulatory interests
