According to the company, the service allows clients to use UPS’ established brokerage system in conjunction with Marken's clinical trial supply chain solutions. In addition to the UPS team, Marken also maintains relationships with brokers in each country who have local regulatory expertise.
The new service ensures all Importer of Record obligations are met while reducing potential exposure to fines, penalties, and forfeiture. It also allows clients to benefit from new trade programs, duty drawbacks, and tax exemptions.
Being able to properly manage these services is key, said Dan Bell, vice president, North America operations and global regulatory affairs – especially for CROs and in the clinical market.
“If you can imagine, for a CRO that has thousands of protocols for many, many pharma clients, dealing with lots of transportation companies, and as part of that, lots of brokerage firms, having that oversight of how each one of those entries are filed and maintaining compliance is a real big challenge,” Bell told us.
“I think until we managed to put these services together, it was really hard to have that on a global level, especially for CROs,” he said.
For CROs, Bell explained that maintaining compliance is important to avoid fines and penalties, as well as the potential loss of import/export rights. The new service aims to provide more visibly and control, especially as more vendors and countries are involved in the clinical trial supply chain.
Additionally, as the industry develops more biologically-derived drugs, such as cell and gene therapies, Bell noted that the challenges are compounded. In Europe, for example, GMOs are specifically regulated, posing additional hurdles from a compliance perspective in both the storage and transportation of genetically modified products.
“The big supply chain challenge, and why you absolutely need to make sure that when you hit the send button and file your entry to both customs and agencies, is making sure that it doesn’t take longer than it should to process because biologically-derived products are nearly always temperate controlled,” he added.
Bell said the number one delay for most people is nearly always some kind of import or export question mark.
“This program that we’ve put together is to make sure that when shipments are going down the road – you’ve found your patient, you’ve signed your patient up for the trial – that you’ve done that work ahead of time to make sure that you understand how long it takes to go through customs,” he explained.
“It’s really clear that this is an issue that’s been there for a very long time, it’s just made more challenging by the number of trials that have a global footprint,” Bell added, noting that it’s an issue everybody is trying to get their arms around.
"The thing that we’ve realized as we started to launch this global brokerage [service offering] … add in the clinical knowledge to that and then the project management … put those three things together, it’s unique in the marketplace,” said Bell.