A pivotal, large-scale, Phase III program conducted globally with sites dispersed across numerous territories that required efficient management of supplies that were in short supply with approaching expiry.

Allocation of treatment to subjects needed to consider complex stratification factors. Available supplies needed timely, optimal distribution in appropriate quantities, over a long recruitment period. Geographical dispersion of sites and labeling restrictions, together with country-specific importation constraints, required that supplies reach sites via a multi-tiered supply chain.

PharmaNet IVRS was utilized to centrally randomize subjects to treatment, and to closely monitor and manage the flow of stock from primary packaging and distribution centers to multiple secondary and tertiary distribution depots.  Multiple supply strategies, including just-in-time delivery to sites, were invoked to maintain optimal stock levels throughout all tiers of the supply chain