Managing clinical supplies effectively and efficiently requires a skillful blend of art and science to balance dozens of variables and considerations in order to create a fully optimized supply chain strategy. Simply stated, the key goals of Trial Supply Management (TSM) are to:
From the start, it is obvious that these two goals are at odds with one another. The easiest way to ensure that every patient gets their study medication on time, every time, would be to over-supply each site with a large amount of stock. Of course, that solution would be extremely costly and would lead to a great deal of wasted supplies that would simply be sent to a destruction facility at the end of the trial. Another method would be to provide a minimal amount of stock at each site initially and then as patients enroll, send frequent expedited shipments to the sites. While doing so may cut down the amount of drug wasted, shipping costs would quickly add up, not to mention the fact that any delays could mean that a patient may not get needed medication. Clearly, there is a balance somewhere in the middle where an effective supply strategy meets both these goals, leading to reduced costs while supplying every patient throughout the trial.