With clinical trials becoming more globalised, the demand placed on the supply chain makes it increasingly difficult to maintain control of shipments that travel far and wide. As companies turn to forecasting systems and IRT (interactive response technologies) to manage their supplies, the ability to assess and simulate your demand enhances visibility throughout the supply chain.

To gain more insight into emerging technologies, Clinical Trials Arena spoke to Michael Koch, director of the supply chain group at Alkermes. Koch manages a group of professionals who are responsible for delivering clinical supplies to their studies globally. In this interview, Koch explains why more companies should be looking to implement innovative technologies to enhance their processes.

Clinical Trials Arena: In your opinion, how well is industry doing in leveraging emerging technologies to enhance supply chain processes?

Michael Koch: With the technology we are using – there are only a few suppliers/vendors in the market that are providing the technology most needed. What they’re starting to recognise is that the ERP (Enterprise Resource Planning) system that our big brothers in the commercial sector are using aren’t necessarily good for those involved at the clinical level. As a result, they’re starting to customize systems for clinical professionals, specifically supply chain professionals for use in forecasting, inventory management, integration with other systems (e.g. IRT – Interactive Response Technology), and so forth.

CTA: You mentioned IRT, how do such technologies improve supply chain operations?

MK: A good IRT system will give you complete visibility of your clinical inventory at any given time.  Not using an IRT can leave you blind past your warehouses and depots. That opens up the possibility of running out of stock, having a dissatisfied patient – maybe a patient even dropping out of a study. So if you’re not using an IRT to control your drug, that’s a very risky, labour-intensive situation. Considering in the US the cost per patient on study could approach $30,000 (it’s a bit less outside the US), if you lose a subject because you don’t have enough drug onsite or the systems in place to keep them, you’re not going to have a productive trial.

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CTA: Do you feel a sense that companies are not making the most in using, say IRT?

MK: That’s hard to tell without knowing what everyone else is using. From an Alkermes perspective, we are reaching a point where even our smaller studies are using IRT. This just makes sense from a supply side and a clinical control side. Certainly smaller companies will not enter into agreements with IRT providers because the associated expense can be cost prohibitive. The medium-sized companies may take it as they come. For us as a medium-sized company, there’s too much value in having an IRT than not at all. So the question becomes one of, since we’re using these technologies in other studies, why not use it in all of them?

CTA: How has the use of these technologies enhanced supply chain processes from a forecasting point of view?

MK: To a degree, we haven’t really seen the full benefits at this point. But certainly with IRT you have a position of inventory at all times; you know exactly where your inventory is, how it’s being used, and how it could be used in the future. With the forecasting technology, what you can do then is take all that real time data and feed it into the system to determine how much to make and when.

CTA: What advice would you give fellow professionals looking to implement new forecasting tools or an IRT system?

MK: For any person who is responsible for conducting a global clinical study, I would say the cost is justified in the success of the trial. Typically, a lot of the smaller organizations would simply not do it, while the medium-sized companies would err on the side of caution. My advice is to vet these two technologies when you’re starting a study. If you feel you can’t do the trial manually, you might want to put money into a technology to control the study.

Ultimately, IRT systems keep getting better and better over time as companies take advantage of the flexibility they provide. In the forecasting space, it’s still fairly new and it remains something professionals are getting to grips with. Going forward, I feel eLabels are the next frontier, and as forecasting tools and IRT become more prominent, such innovations like eLabels will enhance processes further because now you can change things out in the field.


*Michael Koch is the Director, Clinical Supply Chain at Alkermes