comparator sourcing clinical trials

The comparator market is a minefield. While a local wholesaler may be able to provide the product you are looking for, can they obtain the volume you need, preferably as a single batch and with the longest possible expiry date? This may be possible for some high volume products, but can be challenging for biologics with limited inventory available in each country.
Working with an experienced partner, with knowledge of the global market and with an established network of providers, can simplify this process. For example, the KLIFO team is familiar with the advantages of some markets – for example, comparator products can be sourced in some EU countries at a much lower price than in others. Conversely, while product may be less expensive, these countries may only be able to support smaller orders, so may not be the best fit for all projects.

In our experience, while there are some great comparator suppliers in the market…we often buy from these ourselves…while a supplier may have an excellent record of sourcing a particular product, this may not apply across all products of manufacturers. We have learned through experience which suppliers have the best access to particular products. KLIFO also likes, where possible, to keep manufacturer-to-trial supply chains as short as possible. The more links in this supply chain, the more expensive comparator product can be. With many comparator products in short supplier, approaching multiple suppliers with the same request can be counter-productive. In some cases it can create artificial demand, resulting in manufacturers introducing quota systems and other controls, making product even more difficult to source.
Sourcing aside, when KLIFO is managing an entire CTS project, we can ensure purchasing strategies for comparator align with actual clinical trial need. For example, we have been asked to source product to cover an entire clinical trial. Upon working with suppliers and discovering the maximum expiry date available for the product, we quickly deduced that based on the client’s enrolment projections for their trial, a significant amount of this expensive product would expire before it was ever needed. We were able to work with the client, and the supplier, to develop a purchasing plan that better matched the needs of their trial and minimised waste due to expired drug.

In a perfect world, yes. However, this approach does not come without challenges. Clients have reported long lead times and high prices when using this approach. In our experience, the majority of comparator is sourced from the open market.

We can do this. However, we encourage clients to think about the value of doing this.
Consumable ancillaries often have low unit prices. Packaging these into kits at a company following GMP processes may cost more than the ancillaries are worth. Alternative strategies, such as providing each site with an off-the-shelf box of ancillaries may be more cost effective in many cases.
Packaging ancillaries inside drug kits can create additional unnecessary costs. Drug products need temperature-controlled packaging, which can be expensive. Ancillary products, in most cases, can be shipped under lower cost ambient conditions. By adding ancillary items to drug kits, ancillary products must now be shipped under the same temperature-controlled condition as drug products, increasing distribution costs.
While KLIFO is happy to provide the above services, we always ask clients whether the benefits of these ‘clinical trial in a box’ strategies justify the extra cost and time required to deliver them.