Clinical Trial Supply Chain Management Constraints

New Jersey, USA, February 16, 2016 (Newswire.com) - 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.

Constraints like expiration dating, bulk availability and country specific labeling must be taken into consideration. In addition, trial designs (e.g., stratification, randomization and titration), subject enrollment, dropouts, and drug distribution are factors that generate significant uncertainty in the forecast of material needs. Recruitment rates substantially impact supply forecasting for global trials, since supplies bound for one country cannot be redeployed to another without relabeling to accommodate language and regulatory differences. This overall concern in the demand forecast leads to some risk of being unable to supply the right drug to the right subject at the right time. Missing the delivery of trial dosage to subjects can significantly delay completion of the trial and hence delay the time to market which in turn can mean significant loss of revenue. In order to reduce this risk, different techniques can be used, like enhanced overage, increased shipment frequency, dynamic supply rules (e.g., shipping IMP to site after subject has been randomized), and frequent real-time inventory tracking.