TS attendance and speaking engagements at various clinical supply and clinical technology conferences continues at a healthy pace. In February, we'll be speaking and presenting in Rome at VIB Clinical Supply Europe at the end of the month. Here's the link:

http://www.clinicaltrialsevents.com/europe2008/

And, for our faithful blog readers only, here is a sneak preview of our session abstract:

The past several years have seen a shift in the field of clinical supply planning towards a more scientific approach to study demand modeling, primarily through the use of clinical supply simulation tools. As clinical supply simulation has become more sophisticated, simulation tools have developed capabilities to fully model even very complex studies. Since clinical supply simulators are intended for use by business experts rather than programmers, the setup and simulation of very complex studies has been moved from the realm of programming and statistics into the realm of power-user accessibility.

At the same time, traditional IVRS have started to move towards IWR (Web) and, signficantly, away from programming for each study and towards parameterization*.

As a result of all this, two interesting things become apparent: First, that a proper clinical supply simulator contains nearly all of the logic and functionality of an IWR or IVRS. Second, and perhaps more importantly, that the power-users of clinical supply simulators have been empowered, via parameterized UI.s, to construct and model the majority of all study functions themselves - with no programming required.

How fully do clinical supply simulators and IWR/IVRS overlap? Almost entirely. It is easier to see the differences between the two by looking at what they do not share: site shipping information, end user information, actual patient and kit rands, custom data collection, and a few other translation and presentation issues. Nearly everything else is overlap: kit and TG information, visit and dosing schedules, country and site information, internal algorithms, supply chain setup including resupply parameters and lead times, etc.

Taking these developments to the next logical level, it would seem possible to closely integrate Simulation and IWR such that the study setup is done once, modeled and optimized in the Simulator, then exported to the IWR with little or no additional work needed to launch a study. The advent of parameterized IWR as well as full-featured clinical supply simulators has enabled the elimination of substantially all programming and validation efforts traditionally associated with launching a study in IVRS.

What does all this mean? At a minimum, any organization which has adopted clinical supply simulation as a pre-study best practice has . at least in theory . the ability to totally circumvent the industy standard 8-week IVRS programming period (and costs) and launch a live study at any time after simulation is complete.

Our demonstration of a live study setup and launch will seek to demonstrate this point.

*The most advanced such IVRS/IWRs also include provisions for custom .pluggable. code and data, to handle odd cases or custom behavior that is not reasonably parameterized.