Reducing Clinical Supply Overage & Shipment Costs
There’s an estimated – and astounding – 200% overage problem that occurs annually in the global clinical trial industry.
The shelf life of a drug in development is often short and can create a host of challenges. 60-70% of the study drug is not dispensed to patients. One of the main challenges is to get realistic recruitment predictions to plan study drug needs. Often, best case recruitment plans are married with worst case drug supply plans, which creates a lot of wastage.
These problems could become worse with new regulations that will make expiry date extensions through relabeling of the study drug much more cumbersome and costly.
In addition to planning challenges, the optimal use of technology systems like IRT are often a challenge for drug supply managers. Finding the most optimal supply settings for your study requires great expertise. Most often, these settings are approached in a very risk-averse manner by keeping high buffer stocks, and unless there are any drug outages these settings are not reviewed and updated frequently. However, the supply situation at the depot and sites changes constantly. Optimizing drug supply settings regularly provides great potential for saving shipment costs and ensures sites and depots are well stocked.
That’s why we established the Cenduit Drug Supply Center of Excellence (COE) – a unique service to help clients save time and money by optimizing drug supply before a trial begins. The CoE uses proven, proprietary algorithms we have developed over years of experience to help clients create detailed packaging and supply plans that address a variety of scenarios.
Since we established the CoE several years ago, clients have been able to decrease study drug overages, reduce the number of shipments needed, speed the supply processes, and ease the burden of manual work for themselves, CROs and sites.
For example, one client conducting a study in over 50 countries with 26 depots saved an average of 30% on shipments per month, which resulted in $2 million in savings per year. We achieved this by optimizing the resupply algorithm and supply settings for the study. Another client who came to the CoE mid-study was able to reduce drug shipments by 50%, when we updated the way we forecasted for dose changes and how expiry date replacement were handled.
The CoE uses a two-pronged approach to manage the key elements of drug supply – initial planning and optimization. First, we help clients develop supply plans during initial study planning so they can make adequate predictions of what the need will be for the duration of the trial. Second, we use real-time data to understand how much drug will be used at different sites and depots, optimize for the duration of the trial, and update accordingly. This enables clients to supply only those sites with ongoing patients. In addition, we conduct regular reviews of the supply strategy using real time data to make forecasting adjustments.
Through the CoE and our operational excellence, we can help your organization create strategies to avoid or work around the problem of expiring medication, and at the same time reduce costs by eliminating unneeded shipments. We can help you:
- Create accurate forecasting of individual site needs
- Reduce buffer stocks at sites that need to be replaced
- Avoid replacement shipments when a drug expires
- Adjust the shipment size based on a depot stock forecast
- Regularly optimize site supply settings to reduce shipment frequency
- Manage supply chain risks to minimize the ship-to-dispense period
Contact us today to learn how your company can see quantifiable improvement in your drug supply processes through the Cenduit Drug Supply Center of Excellence.