Ensuring your clinical programs have the right amount of supply available when and where patients need them is not an easy feat. It’s a persistent challenge faced by clinical supply teams every day. Undersupply results in timeline delays, or even worse, can potentially impact a patient’s ability to receive treatment. As such, the teams tasked with calculating supply levels tend to err on the side of caution when building stocks, opting for a ‘better safe than sorry’ approach by producing more than what is needed. However, oversupply results in excessive cost that is sunk into manufacturing, labelling, storing and in many cases the eventual destruction of unused materials.

Pooling supplies
The industry is continuously looking for ways to manage these overages, which can result in significant, unnecessary costs. One such strategy is drug pooling, in which buffer levels are calculated across programs or compound levels, rather than individual studies. This creates a “pool” of supplies that can be allocated to a particular protocol as and when they are needed, or ‘just in time,’ A buffer stock freely available to shift between studies results in a substantial reduction in the total quantity of supplies that are needed to support a program. By reducing the level of supply wastage, costs are cut, and savings are made. In short, with less buffer comes less wastage, and with less wastage comes an increased return on investment. It’s a straightforward idea but can be far from easy to implement.

The pressure to improve efficiency in the supply chain increases as the cost of inventory rises. The first major step to driving efficiency is to leverage proper tools, such as Interactive Response Technology (IRT). IRT solutions, which are designed on a trial-by-trial basis, have two main functions: to randomize patients onto proper treatment arms and, crucially, to manage clinical supply logistics.

The most daunting challenge to drug pooling is that IRT systems are protocol-specific implementations—a clear and fundamental conflict with the program-wide view needed for drug pooling. The historical approach to resolve this conflict has been to develop a stand-alone inventory management system to supplement the protocol specific IRTs. This extra system allows clinical supply teams to manage lot and country release, as well as protocol-level approvals for supplies, but it is far from being an ideal solution. These stand-alone systems are prohibitively complex and require ongoing, manual data entry to ensure they match up to real-world material availability. Clinical supply teams now have yet another system to monitor and maintain.

Worse still, as each additional protocol comes online, these systems need to be reprogramed again and again to make sure everything is properly accounted for. That’s not to say that IRT and drug pooling are mutually exclusive. In fact, when fully integrated with an existing Clinical Supplies Management System (CSM), they can yield fantastic results.



Free picking from drug pools
Free Picking (Just-In-Time) works by moving depot-level inventory tracking out of the IRT and into the overarching Clinical Supplies Management System. It means that supplies for the whole program can be pooled and allocated to a protocol—and in many cases packaged/labelled as well—when requested by the IRT. IRT remains the core algorithm for determining how much supply is needed at a specific location at a specific time. The difference is that the IRT system will no longer manage depot inventories or request specific supplies when ‘speaking’ with a distribution facility.

Rather, the IRT will send requests that detail only what is needed at a center. For example, it will ask for two kits of active materials and three placebo kits instead of ordering specific serialized supplies. Under the free-picking model, it is then down to the fulfilment team who will be packing the order to determine which supplies should be included in the upcoming shipment.

Depending on sponsor business practices, the teams can pick stock from materials that have already been labelled for use on multiple protocols, or they can package and/or label supplies for ‘just-in-time’ dispatch. Once the request has been fulfilled, the CSM system transmits a file back to the IRT that specifies the kit, lot and expiry information, and the drug is considered “released.” At this point, normal IRT handling for activities such as shipment receipt, allocation, reconciliation and returns, resume.

The benefits of this approach are two-fold. Applying a flexible, pooled inventory model within the IRT can result in substantial buffer reductions and cost savings, even as new protocols are introduced to the pool. It also simplifies the whole process for the clinical supplies teams. The model eliminates the need for staff to manually keep depot inventories that need to be updated across multiple IRTs, saving time, resources and headaches.

The practicalities of integrating systems
To fully realize its benefits, IRT Free Picking (Just-In-Time) does not have to be implemented at every depot. In fact, in most cases it is supported at the primary distribution centers, with traditional IRT-managed ordering being used at sub-depots. There are two main ways of achieving this, generally referred to as the “no list” and the “partial list” methods.

In the first, so-called because the IRT does not house a master kit list, all distribution initiates in IRT from the primary depots. When a sub-depot needs to be restocked, a Free Picking request is sent to the primary depot to fulfil the order. The primary depot then picks the kits to be transferred and replies back to the IRT with the kit, lot and expiry data for the materials to be transferred. 

Once the goods arrive at the sub-depot, traditional IRT logic takes over. This means that requests from sites to the sub-depot use the industry standard logic of dispatching supplies that have the lowest sequence number and the earliest expiry date.

As suggested by the name, in the partial list model, the IRT retains part of the master kit list, but it is only used by the sub-depots. Orders originating out of primary depots leverage the free picking logic, whereas orders out of sub depots leverage standard IRT logic. In the event transfers are required from primary to sub depots, these will be handled outside of IRT with the clinical supplies team ultimately releasing the transferred ranges for use at the sub depot after receipt.

The appropriate approach for each sponsor organization will vary based on their internal business processes, and both have their advantages. The no list model applies the free picking approach to site and depot transfers, and this allows for maximum flexibility on how regional sub-depots are stocked. 

On the other hand, the partial list model allows for free picking in some regions while retaining the traditional IRT model for others. The partial list approach has its benefits, but it’s worth noting that it does mean that supplies cannot be transferred directly from a primary to sub-depot in the IRT.

Fail safes
As with any IT transformation project, adopting an integrated IRT Free Picking (Just-in-Time) system requires careful planning. This will reduce delays, avoid risk and, vitally, ensure safety remains paramount.

Two key considerations are the Do Not Ship (DNS) logic and the handling of partial or failed shipping. Both of these are traditionally accounted for in the IRT, so they would need to be carefully defined under an IRT Free Picking (Just-in-Time) configuration. The DNS value, which specifies how many days prior to expiry a kit can be included in a shipment, ensures the lot with the earliest, safe expiry date is shipped to sites. Many times the DNS value is dynamically calculated based on variable visit windows and country specific parameters. The opposite is true of depot-to-depot transfers, as lots with extended expiries are needed at sub-depots for subsequent shipments sites. A clear definition is required as to which system (IRT or CSM) is to own the DNS logic and how this is communicated.

Partial or failed shipping also needs to be considered. An IRT will raise an alarm if an order quantity exceeds stock levels or if the inventory is running low. But with a Free Picking (Just-In-Time) interface in place, the IRT can no longer monitor stock levels at the depot. Again, the logic needs to clearly define and intelligently handle situations in which IRT requests orders that cannot be completely fulfilled. Should a partial shipment be sent?  How are supply teams to be notified of these events?

Changing inventory logic
Ultimately, Free Picking fundamentally changes IRT functionality. However, with some forethought and adjustment, an elegant solution can be supported. Success rests on careful planning and making alternative arrangements for processes such as DNS and handling partial or failed shipping requests.

The potential benefits of investing the time to do it right are multiple. Not only can such systems reduce wastage, they can cut the time clinical supplies teams spend manually updating complex stand-alone inventory management programs. Implementing an IRT Free Picking (JIT) model can help organizations significantly reduce costs by managing supplies efficiently over an entire clinical program or compound level.
Ultimately, they can help companies achieve return on investment faster while avoiding introducing any additional risk to their supply chains. 

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Bart Nicholson is Director of Customer Success for IRT at CRF Bracket. He has spent his full career in the validated software industry in a variety of roles across multiple applications.  Bart joined CRF Bracket’s IRT team in 2011. He has an undergraduate degree in Computer Engineering along with an MBA from Drexel’s Lebow College of Business.