A lot can go wrong in the lifecycle of an investigational product (IP). Medrio’s Randomized and Trial Supply Management (RTSM) expert, Ian Davison, shares proven strategies that enable teams to manage their IP journey and optimize their supply chain operations. Discover how positioning your RTSM solution as a central control system reduces clinical complexity and leaves you with clear, actionable data for better supply management.
A Review of RTSM
Randomization and trial supply management (RTSM) is unlike any other technology in a clinical trial tech stack. Unlike other eClinical technologies, an RTSM does more than collect or analyze data. It uses its inputs to direct other processes and systems related to supply logistics and randomization. It is, above all else, a control system. When executed correctly, the control system manages, directs, and regulates all stages of your IP lifecycle from initial packaging and labeling to final collection and destruction.
Although the concept of control sounds simple in theory, your IP’s journey to the subject can be fraught challenges:
- Difficulties maintaining a blind IP across it’s entire lifecycle
- Inefficient distribution leading to wasted inventory
- Issues related to managing and replacing damaged or expired product
Using an RTSM can help you gain the ultimate control over your product while saving you time and money.
Using RTSM as a Control System
RTSM acts as a control system between sites, subjects, shipments, and products. You may be wondering, what does an RTSM control system look like?
With an RTSM you have control over the subject’s journey from registration to screening to randomization and subsequent visits. At all points in the clinical trial, an RTSM is aware of the location and status of all active subjects, including their treatment arm, upcoming dispensation visits, and dispensation requirements.
Allocation to Subjects
RTSM also controls the allocation of the investigational product (IP) to the subjects. In addition to knowing where your subjects are in the treatment process, an RTSM also has a set of dispensation rules. It uses those rules to allocate the appropriate product at the appropriate visit. A good RTSM is flexible enough to deal with product incidents, such as replacing products that a pharmacist can’t find or a damaged kit.
Not only should your RTSM deal with product incidents, but issues that may not be related to a dispensing event. This may include a refrigerator failure or a medication quality recall. A key aspect of an RTSM’s role as a control system is IP management and any related incidents.
With an RTSM, position yourself to understand all relevant subject and IP data. With this perspective, you can drive an efficient, demand-driven site fulfillment strategy and supply chain.
RTSM Supply Strategies
There are several methods an RTSM can use to run your supply chain that can be tailored to your particular trial requirements.
Reorder Point Method
Reorder Point Method is the most commonly used supply chain management algorithm. An RTSM tracks usage / incidents and schedule shipments when the inventory numbers fall below a specified threshold. The supply threshold is established during trial setup. Once supply falls below the threshold, the system will replenish the site.
The demand drive method looks at all the subjects of the site and forecasts their IP requirements. A safety window is chosen based on site requirements, such as one week. An RTSM will then anticipate if there is enough inventory at the site within the safety window If there isn’t enough inventory, shipments are scheduled. Similar to Reorder Point, these parameters can be tailored to your exact trial requirements.
Just In Time
The Just In Time (JIT) method is rarely deployed, but it represents the ultimate strategy in lean inventory management. The Just In Time method essentially sends exactly what is required, just when it’s required. All shipments are triggered exactly when they are required. This often leads to a lot of small shipments, but if your product is scarce or expensive, JITis the best method to efficiently distribute inventory
The biggest benefit of JIT are the savings you make on the IP you never manufacture. Preserving inventory is only half the problem. JIT prevents you from manufacturing, packaging, storing, and generally creating overage that you don’t need to run your trial.
Rethinking RTSM Engagement
Here are a few ways that Medrio’s RTSM is rethinking engagement with clinical trials.
Built to Fit Your Study’s Needs
A trial that Medrio is currently supporting requires blind subject dosing.The challenge for our RTSM was to make best use of the product without being aware of individual subject dosing requirements. We solved this by constructing a dosing table that produced all the possible dosing plans for each possible dose and then ranking each possibility in terms of preference.
This approach allowed us to run a flexible inventory and make best use of the product without knowing exactly how much product was going to be required for each subject.
Reduce Site Overages
For a different trial, subjects were dispensed a cell therapy. The inventory of the cells available at the customer’s laboratory consisted of a series of vials with varying cell counts.
Our approach for this study was to build a Just In Time supply chain whereby our RTSM would pick the appropriate vials from the stock at that inventory to most efficiently distribute the cells. For example, if a subject needed 9 million cells, a 6 million and a 3.5 million cell vial would be dispensed, resulting in only 500K wasted cells. If we were not using a JIT approach,, it would have been appropriate to pick two vials of 6 million, amounting to 6x the amount of wasted cells!
Flexible Packaging and Labeling
Flexible packaging is how we dispense the appropriate amount product at each visit. For example, a subject might receive a single bottle at five visits as opposed to receiving a patient pack containing all five bottles at the first visit.
Clinical trials don’t always go to plan. What if a subject withdraws after two visits? With flexible packaging only two bottles would have been consumed, as opposed to all five bottles being wasted in the patient pack. The same can be said for product issues.In this scenario, you have to replace five bottles as opposed to just one bottle.
Numbering Your Kits
Numbering your kits is key to controlling your product. Numbering gives you complete oversight of the supply chain, and is essential for tracking and reconciliation. We highly recommend taking the time to individually number your kits to allow an RTSM total control and oversight of your inventory.
Let RTSM do the work for you. Our top piece of advice is to bring an RTSM solution in as early as possible during trial development. Early engagement is the key action you can take to maximize your RTSM.
With Medrio, our flexible RTSM allows you to drive while we help you navigate.
Request a demo here.