One of the greatest challenges in the conduct of a clinical trial is managing the expensive and often limited supply of investigational drug needed for the project. Anything that can help reduce waste and shipping costs while ensuring that clinical sites will have the drug they need when they need it is on the ‘most wanted’ list for the pharmaceutical industry. Since Interactive Response Technology (IRT) is one of the primary tools for drug assignment during a trial, the challenge has to be confronted by IRT vendors. How can control be achieved and maintained?
Veracity Logic’s Predictive Resupply algorithm is one of the tools for achieving efficient waste reduction while retaining an adequate drug supply where drug is needed. The algorithm takes into account a myriad of variables that impact on drug needs and timing. For example, the expected early withdrawal rate anticipated for a study can impact on the quantity of backlog maintained at a site for patient visits. Likewise, a study’s projected screen fail rate may determine the quantity of supply shipped to sites prior to randomization. The optimal number of inventory days at a site, the frequency of shipments desired by the sponsor, and shipping duration are also key impact variables that contribute to intelligent drug control.
Veracity Logic adds two more critical features to its proprietary predictive algorithm — the ability to control all key variables at the individual site level, and the ability to easily modify, on a configuration basis, the values assigned to each key variable throughout the clinical trial. In other words, we make Predictive Resupply sufficiently flexible to meet the changing, real-life needs of a study in progress.