Undoubtedly "Trafficking" in a title comes across covert and possibly contra. Despite sounding like a sensationalized news plug, it's just true that all things pharmaceutical feel vaguely dubious - and when at the business of negotiating biopharma boundaries, one must never let on that something undeclared lies unassumingly hidden in the trunk. As a pharmaceutical innovator you find yourself, perhaps nervously, scanning the imposing facades of the most likely legal crossings and are reminded of the vast amounts of energy put into getting your documentational ducks sufficiently in order. The friendliest regulatory guard you can find at his post is wearing a face that tells a story hard to like: He has a job to do.
Everyday reading on new biopharma technologies attempting regulatory crossings are filled with shattered dreams of a possible new life for real world people that could benefit from breakthrough drugs. The looming truth that a dismally low 1 in 5000 drugs reach their intended beneficiaries after all the trouble isn't much help. The name of the game in the no-man's land of this present uncertainty is massive amounts of human energy rife with dizzying reality checks and balances that seem beset with impenetrable barriers to success from the start. The Cinderella drug approval story hoped for by starry eyed believers all hinges on the existence of something akin to informational wizardry. Much as we may crave it, the rational world of clinical trials resists such magic seemingly tooth fairy and nail.
Information traffic report
With voices calling for accountability from every corner of a clinical trial, the extreme level of exactitude required for success understandably confounds the most competent throughout the profession globally. Inadequately marked on and off ramps, U-turns and sundry other detour markers typify the day to day of the clinical site's journey. With sound policy and process in place the tasks are arguably still only marginally manageable. It is increasingly clear that what is being attempted in clinical research may just be too intractable given the condition of 21st century information and the outmoded systems and strategies relied on by clinicians to tease out its importance. Change that is needed is resisted regularly and until the whole system is rethought and/or redesigned, much of the same can be expected. Revisiting the traffic report analogy; hearing of freeway stalls on the local traffic station merely detours responsive commuters to a similar jam on another thoroughfare. "Siri, find the nearest bar."
Self-serving but not shamefully
Just like climate change, known human dysfunctions regularly lead to lethargy or passive acceptance because of the weight resistance heaps upon even the most hearty activist. Given the conversations I've had with a significant contingency of clinical research professionals this may come as an unnecessary admonishment suited best for a so-called choir - we should both recognize it as wildly self serving on my part but here goes. It is encouraging that many industry professionals are thinking about possible solutions and this platform of ours is no exception. It derives from a certain encampment of thinkers on the state of information in clinical trials and what outcomes it leads to. Our project is a massive work in progress and an effort we think you should know about - and while grouped within the backdrop of other innovator types seeking to solve this massive information problem, it sits in the scary and exciting place of the outlier. We think it is because they forgot to consider the obvious because the well trafficked approaches are, well, familiar.
Meanwhile back at in traffic...
Traffic in the context of our approach is indeed a re-routing strategy but in an unexpected way. Rather than taking the next hopeful looking on/offramp, our system sets up information in a way that makes jumping around undesirable connections and to desirable ones a spontaneous leap on the part of the individual user...effectively avoiding the red, congested areas by manipulating the informational roadway as if the staircases of Hogwarts. Progress toward an informational destination without the usual deterrents known in Psynthesys have been quite surprising for its early users.
Psynthesys is designed to make the most advantageous connections between information and the individual clinician. With it, the shortest, least resistant way to complete tasks, make sound decisions, communicate, track, record and report each piece of the process is possible. It possesses the potential to satisfy what I called above the "exactitude of requirements" associated with successful drug development.
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