Challenge

A customer was looking for a comparator drug for their clinical trial. In the US, the drug that was required was on major allocation, and the limited quantities available in the market would not allow for them to source enough product to run their trial. To add additional complexity of the request, the trial protocol required the company to use product that had a US origin, so they could not even consider sourcing the product from a different market. The company reached out to WEP Clinical in the hopes that there would be something we could do to help.

Solution

WEP Clinical first enquired into what the reason was for requiring US-only product. If it was a requirement due to language issues, WEP Clinical would have sourced the product out of another English speaking (labeling) country. However, that was not the case, and in reality, they required a product that was actually manufactured in the US. After some research, we found that there was an option to source product, which was marketed outside the country, but which was actually manufactured in the US. Because, neither the packaging, nor any of other accompanying documentation stated that the product was manufactured in the US, the company had not considered this option. After more research and calls, we were able to get our customer the confirmation they needed to be assured the product was indeed manufactured in the US, and we were able to source the product, so they could complete their trial.