Achieving optimal site drug supply balance: leveraging IWRS for dynamic equilibrium

July 16, 2024
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Summary

During clinical trial execution, meticulous drug management is paramount. Beyond the care of subjects’ medication, it’s crucial to ensure precise drug circulation and minimize wastage. Key considerations include:

Designing a comprehensive drug supply plan to facilitate smooth administration to subjects while adhering strictly to the protocol.

Preventing drug wastage due to excessive supply.

Ensuring comprehensive consideration during implementation to prevent issues like inability to dispense drugs due to factors such as randomization specifications.

FAQ

In a clinical trial, several points must be considered in the supply plan, including the site’s facility environment, the trial protocol design, and the drug preparation. Factors such as the site’s drug receiving frequency requirements, pharmacy storage capacity, drug dispensing cycle and frequency to subjects, dynamic dosing regimen for subjects, drug packaging unit and specifications, and drug validity period all influence the design of the drug supply plan.

The effectiveness of various dispensing designs and packaging methods within the supply plan is contingent upon numerous trial-related factors. Considering these variables, the supply plan must be configured to accommodate the specific drug requirements of each trial site. This entails:

1. Establishing minimum and maximum inventory levels based on the site’s capacity, with automatic replenishment to the maximum level when the minimum threshold is reached.

2. Replenishing inventory according to the anticipated number of dispensations required by enrolled subjects at the site, along with setting an alert inventory to ensure medication availability for new subjects.

These supply options can be implemented individually or in combination. When coupled with site enrollment rate predictions, the IWRS system can effectively ensure subject medication while mitigating wastage resulting from excessive drug delivery.

Challenge

In a multi-center, randomized, blinded, active-control phase III clinical trial, the Taimei IWRS team effectively ensured the safety of over 1,400 subjects through the implementation of both basic and intelligent supply plans. This comprehensive approach facilitated seamless patient enrollment and drug administration, averting any potential issues with drug dispensation that could have led to enrollment failure or protocol deviation. To tackle drug waste and supply inadequacies in clinical research, Taimei’s IWRS team devised a basic supply plan tailored to each site’s inventory conditions. Additionally, they integrated an intelligent supply plan capable of dynamically predicting drug consumption based on individual site enrollment plans, automatically generating shipping orders to support the smooth enrollment of subsequent subjects.

Solution

This instance demonstrates how employing intelligent supply planning and precise drug supply management can effectively address drug supply issues in clinical research, ensuring the seamless advancement of such studies.

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Achieving optimal site drug supply balance: leveraging IWRS for dynamic equilibrium

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