Haversac Supply® is an interactive web response system (IWRS) that safeguards accurate and timely deliveries of clinical trial drug supplies. Treatment containers dispensed with Haversac Supply® are captured in CDISC Drug Accountability (DA) standards for FDA Good Clinical Practice (GCP) compliance and for output to communication norms like the Study Data Tabulation Model (SDTM).
Haversac Supply® is fully harmonized into the Haversac suite of applications including Haversac Study Capture® and Haversac Randomization®. This means exact availability of time dependent Subject assigned treatments; even within complex crossover study designs with multiple epochs, treatments and per-treatment bottle/containers. Haversac Supply® ensures a Subjects next epoch treatment will be available to dispense when needed, while keeping expensive site inventories to a minimum.
1. Haversac Supply® extends the power of the Haversac EDC® visual interface to guide site acceptance of shipments and compliance to Drug Accountability (DA) requirements.
2. Only treatment containers meeting the Arm-Epoch requirements of each Subject are made available for selection by the Haversac Supply® user. The selected treatment container ID is automatically inserted into a new CDISC compliance Drug Accountability (DA) form; ensuring compliance and eliminating data entry errors. A replacement container, or study dependent, the Subject’s next epoch treatment container, is automatically ordered when the current once is dispensed.
3. Treatment container shipments are received in Haversac Supply® using a form that is customizable to study requirements. Any type of data can be documented, such as temperature monitoring or physical condition. As shown, users can be asked to accept or reject each container for granular Drug Accountability (DA) requirements.