DHL has acquired or partnered with four GMP clinical trials supply depots in the Philippines, Egypt, Belarus and Turkey.
The company, which provides logistics services for clinical trials, integrated the Turkey site, which it already owned as a domestic depot, into its global clinical trials supply network. It partnered with outside companies in the other three countries to bring their facilities on board.
Although DHL is “opening steadily each year” more facilities, the company strategy is to limit the stops in its supply chain where possible, Alex Klim, product manager, Clinical Trials Logistics at DHL, told Outsourcing-Pharma.com. “We work to a supply chain principle – the fewer depots, the fewer people handle the medication on the way. So there’s better quality assurance.
The biggest challenge for logistics suppliers for clinical trials is keeping up with global regulation, he said, and this includes the number of stages in a supply chain.
“We try regional set-ups, shipping across borders as little as possible. But there are some countries where regulations require shipping from a local depot.
“We need to import in a different way. Europe is not completely a free market – you can’t ship directly to investigator sites all over Europe. Sometimes you have to ship to a local wholesaler or pharmacist.”
In Portugal for instance, Infarmed, the National Authority of Medicines and Health Products, can require suppliers to ship trial supplies via a local registered pharmaceutical entity.
The company manages its 25 international trial supply depots via a “control tower” system which aims to keep on-site and transport procedures consistent around the world to safeguard the integrity of clinical trials.
“That means not just on the investigator site but seeing supplies are transported in the same conditions. You need to use the tools of logistics professionals – specifically temperature control: making sure items are packed in the right way so they preserve thermal energy.
“For example, with packaging temperature-controlled shipments, where the depot is, [workers] should pack products in a box, put the ice gel pack in, and seal it. When we went into India we found the norm was the couriers would turn up with a box and pack items in [themselves], and then they would put the ice pack in. We insist it’s all done at the depot.”
The company has created IT interfaces for its external transport providers, Klim told us, which update information from different carriers live in real time in the central system.
Clients can then use DHL’s tool to view their inventory, he said, without needing to find out who is the transport provider for different legs of the journey.
The interfaces fit into a larger inventory management system that allows trial managers to instantly check their stock levels, he said, whereas the traditional way – downloading inventory figures onto spreadsheets – often led clients to information up to two weeks out of date.
No bad surprises
Increased controls on R&D budgets in the current economic climate provide another challenge for pharmaceutical commercial services, Klim said. Accurate budget forecasts are needed to avoid “bad surprises” for clients. While logistics are not a large part of clinical trials budgets, delays or miscalculations can cause high indirect costs, he said.
“Study managers are under more pressure themselves. Maybe 20 years ago you could react differently to problems, and choose the most expensive solution.” This is no longer possible, said Klim.
DHL is also seeing accelerated demands from clients, he said, driven by a race to new markets. “They want to get into countries as quick as possible.”