Whitepaper

Clinical studies are seriously important and an expensive part of the drug development process as it is composed of the planning and scheduling of all transactions, operations and organizations during a study, beginning with active ingredient manufacturing, followed by drug manufacturing, packaging, labeling and distribution to depot and thus to the clinical sites, and ending with dispensing the drugs to subjects at each clinical site located in different geographic zones. Not only is subject enrollment highly variable, but uncertainties also arise in manufacturing and shipment lead times, failure in process and in production supplies. Furthermore, the life of a clinical trial materials supply chain, which is in the range of 1-2 years, is significantly shorter than that of a commercial supply chain, which usually goes beyond 10 years. As a result, the strategies used to buffer the uncertainties in commercial supply chains become inefficient as probable values cannot be efficiently used as targets