ParagonRx, founded in 2001, is made up of biopharmaceutical industry professionals who perceived the need for an independent entity that could help develop programs to mitigate product risks and optimize use. Disciplines represented by our post-graduate level staff include medicine, pharmacovigilance, pharmacy, brand management, product development, biostatistics, project management, and application development.
Our approach starts with the idea of the right patient on the right therapy at the right time for the optimal dose and duration of treatment. While a CRO may focus on a specific study population, protocol design and compliance in the controlled environment of trials, we address the practical realities at the point of care in which a drug could potentially be offered to a diverse patient population, by varied health professionals, in the absence of a protocol. So we start with "what really happens" so we can better see "what should happen" and "how to make it happen".
We believe that the risks and opportunities presented by innovative marketed products in today's safety conscious environment are unique and deserve rigorous attention by a firm that focuses exclusively on when and how patients are seen and treated. Our clinical expertise, coupled with years of experience with documented processes, avoids conflicts of interest, stresses patient safety, and helps therapies reach those patients who could benefit most.
Originating in the aerospace industry, FMEA (failure mode and effects analysis) has been used since the 1960's as a means to identify potential systemic breakdowns that create undesirable outcomes. Each process step necessary to achieve a certain outcome is examined and potential "failures" that could lead to undesirable outcomes are identified. Then steps that can be taken to prevent such failures or reduce their impact are developed and implemented.
RxFMEA®, our proprietary biopharmaceutical version of FMEA, focuses on the process of prescribing, dispensing, and self-care -- describing what can go wrong in a complex process that involves physicians, pharmacists, patients and caregivers. We then prioritize these risks quantitatively, then work with clinicians to identify and design practical interventions to address the risks without disrupting clinical practice. We involve the target audience(s) up front and develop tools that enable physicians and patients to help educate and actively support each other.
The power of failure mode analysis is that it is a transparent, well-known, state-of-the-art method for identifying and prioritizing risks for intervention. It enables us to pinpoint those risks with the greatest frequency and/or severity where intervention is most important. This is documented using a scoring system and tracking software, helping to easily deconstruct the process for regulators seeking evidence rather than "this is what we think." In a Guidance endorsed by other major international authorities, the FDA has noted that FMEA is an accepted methodology for risk assessment and evaluation.
Our CareMap™ approach, based on observing physicians as they deliver care to their patients, documents the techniques and processes they have innovated to treat disorders and manage patients efficiently and effectively. Like a flow chart, a CareMap™ shows how the most experienced clinicians optimize their care of such patients, including some of the knowhow, techniques, and insights that can only come from real world experience. This complements treatment practice guidelines and patient flow maps with what experienced practitioners actually do and what really works.
These maps go beyond what physicians say they do in marketing research to help explain how and why some physicians succeed with prescribing a medication while many others do not. These insights can be leveraged to develop appropriate use programs, decision support systems, and enabling tools that can help other clinicians prescribe successfully based on their peers' experiences, enhancing appropriate prescribing, medication compliance and favorable outcomes.
Ethnography literally means "portrait of a people." Market researchers often study how prescribers react when shown product information or materials -- for example, what effect a sales detail or journal article has on their intended prescribing. ParagonRx instead focuses on the next steps after product selection, namely, how clinicians actually prescribe and manage therapy, the challenges they encounter, and what they do about those.
In the best portraits, you see both the beauty and the warts. Using a single observer who is clinically trained, we go into a physician's office to document what really happens, where problems arise, how physicians adapt, and what tools and resources may improve patient care.
Successful ethnographic research in biopharmaceuticals requires an experienced individual with a clinical background - it is a peer-to-peer approach that requires both clinical expertise and experience. And, in today's world, a company must respect patient privacy by documenting and complying with HIPAA requirements.
Even then, the best observations mean little if you can't act on them. Some ParagonRx staff conduct and report evidence-based analysis, and others specialize in translating this evidence into action. That takes ethnography beyond research and ensures that it is leveraged into appropriate interventions that improve prescribing and care delivery.