Challenge
It is challenging for working clinics to ensure sufficient inventory of treatment and control medications or supplies are available throughout a clinical study. Prelude Dynamics was challenged to identify an inventory management system that was smart enough to know when medications and supplies were used at the patient level, keep track of current inventory, and reorder supplies as they became low. One challenge to accomplish this is the varied sizes of clinics and expected enrollment for each site, which required something more sophisticated than a one-size-fits-all solution. Rather, inventory thresholds would have to be able to be customized per site, and at least some portions of the inventory management system needed to be blinded from other site personnel.
Proposal
Prelude Dynamics proposed the client use VISION™, an electronic data capture system, which already has an Inventory Management Module to manage inventory. As the Treatment Dispenser recorded when a patient had received medication or supplies and the amount dispensed, the inventory module would update the inventory on-hand. Prelude proposed to add to VISION™ a feature that would trigger an automatic order when supplies reached a certain threshold, which could be set separately for each site. In addition to VISION™ automatically placing an order, the Treatment Dispenser, study Project Manager and Monitor would be automatically notified via email that the order had been placed.
Background
It is often difficult for busy clinics participating in clinical research studies often to manage the inventory required to be available for the study. Successful inventory management requires a designated person to keep track of how much is on-hand and order additional inventory as necessary. This person usually has other day-to-day responsibilities that make keeping up with this task difficult. If the designated person were to forget or put off the task the enrollment and treatment of subjects could be jeopardized because medication or supplies are not available. Automating this process would greatly reduce the effort involved in participating in the study and would ensure a better outcome.
Solution
Prelude staff trained the study staff to utilize VISION™’s existing Inventory Management Module to keep track of inventory as it is dispensed to the patient and logged in the dosing eCRF. The solution included setting the module up to handle the following scenarios:
- Allow study management to initial inventory sent and site shipping information.
- Allow initial inventory and future inventory received to be logged and tracked.
- Aggregate the dispensing information into a summary table.
- Reconcile the on-hand inventory in real-time.
- Allow minimum and maximum inventory threshold levels to be set at the site level.
- Automatically order additional medication and/or supplies when the inventory meets or falls below the minimum threshold, for the difference between the actual amount on-hand and the maximum inventory threshold.
- Notify the study management personnel at site treatment dispenser that an order has been placed.
- Manage final reconciliation at the end of the study, allowing the site to enter return shipment information for remaining inventory and study management to reconcile the shipment when received.
- Provide tracking method for deviations or comments/notes to file when medication is not returned by subject or when medication is missing or lost.
- Provide ability to track if empty bottles are collected and shipped back or disposed of as required by the sponsor and protocol.
- Allow site personnel access to certain information, such as inventory received, but not any information that might disclose the treatment group provided to each subject in order to protect study masking during the study, but allow access to all the information upon study completion.
Results & Benefits
As a result of using VISION™, the burden on site personnel to keep track of inventory has been greatly reduced. The sites report that they appreciate the automatic reordering and email notifications of placed orders, adding that it is “such as stress relief to have VISION™ order for them.”
The study Project Manager was able to enter initial inventory ordered and shipped to the site, along with site shipping information, simplifying tracking all inventory information in a central location. She received email notification when the Treatment Dispenser entered the initial receipt of the inventory into the system, confirming its arrival. She was very pleased with the entire module, noting that, “It is wonderful to know that I can relax about whether the sites are keeping up with the inventory and reordering meds and supplies when they are getting low because it happens automatically. There are so many other things I have to keep track of. It is helpful not to have to be burdened by the inventory management.”
The Treatment Dispenser finds it useful view a single table for a full history dispensed medication and/or supplies. He appreciates instant viewing of aggregate dispensed and automatic reconciliation of inventory, and is able to add notes directly on the dispensing form if there is a discrepancy in the amount of medication returned or if there are missing medications or supplies. All these notes are aggregated automatically in a note to file with details about the form and field, who entered the note and when it was entered. This makes it much easier than having to enter all these details manually. He indicated that he was extremely satisfied with the inventory management. He said that keeping up with the inventory and reordering was so much less burdensome and stressful that it had been previously. In fact, the Treatment Dispense indicated he wished all studies used VISION™’s Inventory Management module and thinks everyone should consider using VISION™ for future studies. He said it was intuitive, easy to use, and followed the work flow well. Other treatment dispensers at other sites had similar positive experiences.
Throughout the study, sufficient inventory levels were maintained to be able to enroll all patients eligible for the study who were willing to participate. This gave all study personnel more confidence in their ability to successfully enroll a new subject every time.
