In order to help meet global enrollment targets, the Sponsor wanted to reduce the number of clinic visits each subject would need to make while still being able to assign drug every week. The goal was to find a way to deliver drug directly to subjects at home, and on a discretionary basis. Additionally, the Sponsor wanted to allow sites/subjects to be able to choose (and change their minds if need be) at a visit level whether to receive drug at home or by visiting the clinical site.
The Veracity Logic Solution:
A Direct-From-Depot option was added to the IRT system for all visits at which direct-to-home shipping would be allowed. At the Site level, the list of Resupply options in which the Site could participate was expanded to include the Direct-to-Subject option. At the Kit level, the system defined whether a particular kit type could be sent direct to Subjects (e.g., run-in kits were excluded from direct-to-subject). When all three key variables – Subject Activity, Site Resupply, and Kits – were in agreement, Direct-to-Subject shipping was enabled. The Subject visit was recorded, and an Activity Notification was sent to the warehouse with a request that the assigned kits be shipped to the subject’s address (on file at the warehouse).
Shipment options could be modified by each clinical site as needed throughout the study by means of a simple configuration change. By these methods, sites were able to easily adjust to the subject’s preferences while boosting enrollment and compliance.
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