A few years ago, we asked a group of clinical research sites if there were any challenges in receiving, tracking, or storing ancillaries. The overwhelming consensus was that if any challenge existed, it was that their shelves were overflowing. In some cases, extra ancillary supplies had to be discarded.
Given that these ancillaries are also less costly, it makes sense that supply managers focused on forecasting and managing higher-cost IMP supply. It is, after all, the supply manager’s #1 priority to ensure the patient never shows up to their visit and their treatment isn’t there.
But what if you have enough of the right drug for the patient, but no way to administer it? We’ve heard stories where that very scenario is happening. Ancillaries have transitioned from something that has been taken for granted to something that might derail a trial.
COVID has been the catalyst for most of these disruptions. We’ve held many roundtables on supply chain disruptions from COVID. Surprisingly, the supply chain for IMP held up fairly well. Manufacturing IMP is tightly controlled by the trial sponsor and they are backed by teams of people to help figure out how to import their IMP.
The same can’t be said for ancillaries. As a sponsor, you are reliant on the manufacturers of the syringes, etc. If they are having trouble accessing the raw materials to make their product, there is no supply. Sponsors also don’t have the same resources dedicated to researching the ability to obtain or ship ancillaries into certain countries. You have less visibility and less control.
So what can be done? There are three main approaches to consider for ancillary management.
- Ancillaries are supplied by the clinical research sites. This alleviates much of the pressure for the sponsor organizations, but the sites may also have challenges securing the needed items. Sites may prefer not to deal with the hassle of obtaining supplies. You also run the risk of sites choosing specific sponsors to work with that doesn’t ask this of them.
- CROs or other third-party providers supply them. This option is low effort for both the sponsors and the sites, however, it can be much more costly. What you are saving in effort, you are paying for the experience, oversight, and management of ancillary supplies. Using third-party vendors may be very worthwhile when it comes to leasing equipment such as refrigerators or centrifuges but perhaps less so when they’re supplying tubing for infusions.
- Ancillaries are supplied by the sponsor. Procuring the right supplies and importing them to the right countries can require expertise, but if you have reliable sources this can be the easiest way to get the sites what they want and need.
If you, the sponsor, or your CRO are supplying ancillaries you then have the choice to either manage the inventory on spreadsheets and via email or use a system like a Randomization and Trial Supply Management system (RTSM). There are pros and cons to each approach. However, for the purposes of this blog, we wanted to provide insight into the considerations for using the RTSM.
Once you’ve decided to use your RTSM to manage your ancillaries you can decide to treat them just like you would your IMP or you can use your RTSM as simply an inventory management system.
- Track like IMP: Dispense ancillary kits to each patient alongside your IMP, treating them like just another kit to be assigned to a patient
- Inventory management only: Track shipment requests, process shipments, and allow site inventory to be marked as lost or damaged, but don’t associate with distinct patients
Track like IMP
Sites may find it simpler to treat your IMP and ancillaries in the same manner. You also have the benefit of projecting demand based on future patient visits, which can really help with your resupply to make sure you have enough but not too many ancillaries at a given site.
If you go this route, it is important to think through how your returns and accountability will work. Often ancillaries are not included in that process so you need to ensure your RTSM can exclude them from the accountability performed on IMP. However, what really seems to be problematic is keeping the site inventory accurate. Numbering your ancillary kits provides a higher level of accuracy for site dispensing. Conversely, if your ancillaries just have a lot of numbers on them, chances are the sites will pull what’s available and make corrections (a lot of corrections!) later.
Inventory management only
Sponsors are often concerned that sites will over-order or wait until the last minute to request a resupply, but in our experience, they normally do a nice job of placing orders in a timely manner – provided the process is streamlined. This is where an RTSM can help, by giving them an online form to submit and clear email notifications to let them know when their resupply is on the way.
The sites draw down their supply as needed, without having to check which lot was given to which patient. This makes it easier for them, but there’s a higher potential for waste which may be a problem if you have a very limited supply of ancillaries. However, you can set caps for how many sites can order at a time and require specific information from the sites just like a paper order form. And when sites submit their orders, your RTSM notifies the Supply Manager to review the order. They can see the current patient activity in the RTSM to help them make an informed decision on exactly what to send.
Either way, if you use your RTSM to track ancillaries you’ll be able to see all the shipments sent to each site. Sites can track their shipment receipt in the system or even have them be auto-received. You can also share ancillaries across studies, even if you’re not sharing your IMP.
It’s good to keep in mind flexibility as you set up your RTSM for ancillaries. Know what identifiers can be changed mid-study and which are fixed at the start. For example, you may want to call your syringes “syringe” instead of using the manufacturer’s name. That info is best kept in the lot description so that you can swap out different manufacturers as needed without having to process a change order. It’s a sliding scale, the more defined your process, the more benefit you are going to get out of using your RTSM for managing ancillary supplies.
Ancillaries should be top of mind
Whatever approach you take, ancillaries are no longer something that should be taken for granted. To ensure your patients are never without their medication, ancillary management is now a critical part of the process. Leveraging the RTSM can provide the needed visibility to address the complexity and alleviate the pressure on sponsors and sites for tracking ancillaries.
Amy Ripston, 4G Clinical Vice President of Marketing, has over 20 years of B2B experience, of which she spent 9 years in the bio/pharmaceutical industry. Amy has a knack for identifying market trends, synthesizing content, engaging thought leaders, and connecting businesses with innovative solutions.