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Using Enrollment Thresholds

Problem:  A classic struggle in the world of clinical trials is how to ensure there is ‘just enough’ drug at each study site throughout the trial – that is, how to achieve minimal wasting of precious investigational product, but minimize, at the same time, the risk that a site will run out of stock and miss enrollment opportunities that cause study delays as a result. How can your IRT (IWRS/IVRS) system help?

Solution:  Veracity Logic’s VLIRT® system allows clients to assign individual enrollment thresholds for each site in the study.  A site can be defined as a Low, Medium, or High enroller based on best industry information at the onset of the trial. Each enrollment level feeds into the study’s resupply and inventory management algorithms to determine the optimal amounts of drug to be provided to the site – at initial shipment, for baseline maintenance, and in terms of resupply alert levels for study drug. Recognizing that the one firm rule of clinical trials is that change will occur, enrollment thresholds in the VLIRT® system are easily configurable throughout the study – threshold designation can be changed by Project Managers as events dictate at any point in the trial without requiring custom coding or vendor involvement.

The application of enrollment thresholds is particularly useful when the design of the study doesn’t permit the use of predictive resupply functionality. Predictive resupply is not always a good option for low numbers of users and dosing visits, nor for studies where visits are too close together to handle a just-in-time approach to shipping.  In such cases, enrollment thresholds can help project managers put study drug where it will do the most good throughout the trial.

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