12.08.23 -- Test Clinical Supply Editorial

In a world shifting toward advanced technology, the new EU Regulation No. 536/2014's Annex VI is forcing us back into the paper age; specifically, the new requirement to print the expiry date on the primary container label, not just the external carton label. This article describes what is now required, how we got here, and how we can move the industry forward.

It is challenging to keep track of inventory positions at clinical sites, depots, and clinical packaging organizations. Randomization and trial supply management (RTSM) systems do not encapsulate all the necessary data. It is vital to have an internal central inventory system that maintains oversight of the IP inventory from start to finish and to manage resupplies.