Clinical trial ancillary equipment and supplies encompass an astonishing variety of products and categories. This includes everything one might need to conduct a clinical trial, from IV bags to centrifuges, blood pressure monitors to syringes, refrigerators, and everything in between. The list is extensive, and sponsors and CROs may not be aware of the full complexity of procuring these items. However, getting the right supplies and equipment in the right quantity, on time, and at various national and global sites is critical for the success of a clinical trial.
To learn more about the unique challenges relating to clinical study ancillary equipment and supplies that sponsors and CROs should factor in when planning a clinical trial, I sat down with Imperial’s medical equipment and supplies subject matter expert, Ryan Seeley.
Ryan masterminds the procurement and management of these products for our sponsor and CRO clients. He is the Imperial category manager for the medical equipment lifecycle and is an expert in the care and custody of lifecycle management. Ryan has also led process improvement initiatives related to medical supplies and equipment for several companies.
Q: What challenges do you see with clinical trial ancillary supplies and equipment procurement that might not be considered during the planning process?
A: A frequent mistake is not allowing for appropriate timelines for procuring goods and services, which can cause issues. Frequently, study teams wait until the last minute to place an order, which becomes problematic if there are any hiccups along the way. A recent example that comes to mind is when Hurricane Helene impacted a Baxter plant that was producing saline solution. This led to a shortage, so study teams who did not purchase sufficient quantities of saline in time were in a bind. It’s ideal to be a little bit ahead of the game in terms of timelines – not only because of potential acts of God but also because medical supplies can often be on backorder.
Because of the differences in clinical trial types and durations, it is difficult to suggest an exact number of weeks or months for planning. As a rule of thumb, the sooner orders are made, the better. Naturally, expiration dates play a role. But assuming the lead time on a product is 2-4 weeks, my suggestion would be to order supplies at least 5 weeks before they are needed.
Q: What are some unique challenges international studies present?
A: Although there are more moving parts, the essential process is the same. One different aspect is the issue of regulations. Products with FDA approval may not be approved for use in the EU or other countries. That makes the Imperial policy of regional sourcing so important. For instance, PVC is a common plasticizer that is used in everything from syringes to tubing, from IV bags to various kinds of medical supplies.
The EU is now getting ready to ban the use of PVC. Although it has not yet been phased out, most EU manufacturers have already stopped production in anticipation of the change. So when our clients ask us to procure PVC bags for clinical trials in the EU, this becomes a challenge. Even if alternate products are being produced, other materials have often not been tested for compatibility with an investigational product or are known to be incompatible because the drug adheres to or is absorbed into the material.
Cross-border shipping can also be an issue. For example, not all goods can be easily imported from the U.S. into Canada. An experienced provider like Imperial knows which products are easier to import into a given country than others.
Q: What are some solutions to these challenges?
A: Be aware of these potential pitfalls ahead of time.
In terms of timelines, it is vital to allow enough time to import the goods. Customs clearance, documentation, and licensing all take time. The lead time for us to receive a product does not mean it can be delivered to a specific site in that period of time. It still needs to be shipped, which can take anywhere from a week to a month due to global logistics.
When it comes to the availability of products like PVC bags, pharmaceutical companies can prepare by conducting the necessary compatibility studies to hopefully have multiple options available that match regional manufacturing trends and regulations. This is not something manufacturers or suppliers can do, so it would benefit drug makers to keep track of new and pending regulations. In fairness, this can be quite labor-intensive due to the various regulatory bodies.
Q: What are some of the challenges that study teams need to think about or plan ahead for when it comes to clinical trial ancillary supplies and equipment?
A: It is always a good idea to gather information about locations, sites, and countries as well as timelines for a study, and to communicate that information with suppliers. This gives us the information we need to help you navigate potential hurdles. It also helps us provide a more accurate quote – without specifics, we can only provide generic pricing. At Imperial, we generally take and coordinate orders for supplies used in studies all over the world and then determine where and when to purchase those products regionally. When sourcing supplies for trials conducted both in the United States and in Canada, for instance, we would typically procure these from the same source and ship across borders. For trials with sites in the EU, this procurement would occur through our U.K. office.
Q: What additional information should clients be aware of?
A: Despite our best efforts, mundane events, bureaucratic hurdles, climate events, and – as recently as 2020 – global pandemics can work in unexpected ways to make supplies scarce. In a sector where a wide variety of items are needed, the likelihood that any given item may be difficult to procure is that much higher. So, it is helpful to plan ahead.
Even though the supply chain disruptions of the COVID-19 era are mostly a thing of the past, we now have a landscape that has changed in ways both good and bad. Today, much of the clinical trial supply chain operates on a just-in-time basis instead of the surplus state we had before. On a positive note, this created an awareness of the lack of alternate suppliers and led to companies offering similar products that can serve as alternatives. While much of the supply chain originated in China before the pandemic, we now see manufacturing sites emerging in other countries.
Still, shortages will continue to occur and can have long-lasting consequences. That makes it all the more important to not only plan well and far in advance but also communicate clearly with suppliers.
Q: Why should sponsors and CROs choose Imperial for their clinical trial ancillary supplies and equipment needs?
A: At Imperial, we care. We know that in the end, clinical trials are all about the patients we serve. Focusing on that mission is what makes our people and teams go the extra mile to deliver the best products and the best possible service.
We collaborate with our clients to review their protocols, consult with their teams, and procure, warehouse, and distribute their study supplies and medical equipment worldwide from our operating centers in the U.S. and the U.K. We also offer rental or purchase options that fit the study’s needs.
Our global logistics experts ensure that the clinical trial ancillary supplies and equipment are delivered to the right sites on time, every time.
Contact us to talk about how Imperial Clinical Research Services can help with your ancillary supplies and equipment needs. You can also click here to visit our website.