Benefits of Implementing EDC & Medical Coding with RTSM
The Fountayn Platform delivers more than $1.3 million in Cost Savings for Phase III Clinical Supply Management and Shipping Procedures.
Overview
Technology advancements for the clinical trials industry has created cost savings in all areas of the trial process. Web-based systems drive efficiency in trial design, randomization, clinical supply management, and more. The Fountayn Platform, including RTSM supported a client’s two year, Phase III study seeking a cure for multiple sclerosis and delivered cost savings of more than $1.3 million.
The study consisted of 500 patients at 80 sites in 11 countries throughout Europe, and three treatment regimens - the study drug, placebo, and the comparator drug. The start-up biotech company needed a cost efficient solution to address a variety of challenges in randomization and clinical supply management and selected the Fountayn Data Platform, utilizing EDC & Medical Coding to capture and clean the data, while using RTSM to manage randomization and clinical supplies.
Challenge
Optimizing clinical supply management, shipping procedures, and cost were a priority for the client.
“Fountayn’s unique configuration abilities allowed us to deliver exactly what the client needed, saving them significant expenses on investigational product and supplemental shipments.”
Clinical Supply Management
The study involved a complicated clinical supply management scheme with a total of 6 kit types for the trial - a 30 day supply kit for the study drug, the comparator and the placebo, and a 3 day reserve kit for the study drug, the comparator and the placebo.
The drug was expensive to manufacture and package with a value of $10,000 a year per patient; the comparator was even pricier at $40,000 a year per patient. A limited quantity of both the comparator and study drugs was available as high manufacturing costs translated to less drug produced.
Shipping Procedures
The trial drug required precise storage temperature between 2 to 8 degrees Celsius. A very narrow shipping lead time was required for this trial to optimize just-in-time (JIT) supply upon randomization. Shipping costs for this study were understandably high, at an estimated $4 million and a targeted cost-cutting area.
The kits were distributed unevenly from one central and four local depots, according to the following schedule:
The local depots had limited capacity to store kits and the distance of site location from the local depot created varying shipment lead times. These issues prevented the client from developing one distribution solution, either pre-stocked or JIT, to accommodate all sites.
Cost
Implementing an entire just-in-time (JIT) shipment solution of 500 kits at $8,000 a piece would have cost an estimated $4 million in shipping fees alone; considering the time required from staff to manage on-site inventory and communicate with the central and local depots, the expense grows. The additional risk of losing trial product to shipping outside the tight temperature requirements not only adds expense, but lead-time issues along with the manufacture of more trial product.
Solution
Fountayn worked with the client to develop a supply distribution strategy utilizing RTSM to combine multiple inventory management tactics into a comprehensive solution.
RTSM by Fountayn
Fountayn worked with the client to ensure sites received JIT inventory, where necessary, and allowed pre-stocked shipments, where possible, to reduce complexity in execution and overall cost. Cost savings in excess of $1.3 million where realized using the hybrid approach in RTSM by Fountayn.
The initial supply distribution based on each site’s location and the transit time from the local depot to the site were reflected and configured in RTSM to automatically request shipments with the appropriate contents to fulfill the independent needs for each site.
To resupply all sites throughout the study on a regular basis, Fountayn configured RTSM to allow the client to conduct a sweep in the Fountayn Platform to measure the amount of inventory needed for the next period considering the following variable:
Active Patients Only
Used Supply
Schedule Visits
Placebo Switched at Month 4
Full & Reserve Kits on Site
Site-Defined, Back-up Kits
Users could view the calculated inventory amounts and approve each shipment in Fountayn prior to sending the request. All the while, study teams were working on the same real-time data since patient data, randomization, and inventory were all captured and managed in the Fountayn single database architecture.
Results
Leveraging The Fountayn Platform resulted in cost savings of over $1.3 million for the trial as a result of a streamlined supply process and consistent data quality, delivered in real-time. Additional cost savings were realized through using RTSM to calculate and suggest re-order quantities, versus a manual process, which are not estimated here.
By pre-stocking half the sites using RTSM, Fountayn was able to optimize the number of kits shipped at any given time, reducing the number of overall shipments during the study decreasing shipping costs to $2.6 million. Additionally, JIT delivery at randomization eliminated the need to pre-stock half of the sites, which saved on upfront costs and helped manage the inventory quantities.
*Fountayn Formerly known as Datatrak