The complexity of new drugs and trial protocols will increase the use of dedicated supply chain providers, according to the survey of 250 key decision makers of clinical trial logistics services from pharmaceutical companies, central laboratories, CROs and manufacturing service providers in North America, Central & South America, Europe, and Asia.
Ariette Van Strien, SVP of Commercial Operations for Marken, told Outsourcing-pharma.com the survey didn’t reveal too many surprises and it “confirmed what we were thinking as it seems for most clients that spending is increasing.”
Time, temp and tracking
Temperature control capabilities (57%) and guaranteed on time delivery within specifications (53%) as well as real time traceability of shipments (49%) were the dominant reasons for companies moving to specialty logistics providers.
More than 50% reported that their organization had moved their clinical trials logistics business to a dedicated supply chain provider within the previous two years.
“When you look at the data, only 4% thought” spending for logistics would decrease, and most said that they’re looking to work with a specialty company similar to Marken, Van Strien said.
“Overall, there seems to be more of a tendency toward more global trials – for instance, the average Phase III trial was conducted in 39 countries, whereas in 2006 it was 18 countries,” she said. “We see more Latin America growth and more growth in Asia...as well as more remote regions linked to vaccine development or orphan drug development.”
In some cases, CROs and sponsors “need to go to 30 countries to find 100 patients” for an orphan drug, “and they’re not necessarily in major cities,” which can add to the burden. The study was conducted by That’s Nice Research, an independent survey group.
Complexity and data access
Increasing complexities in regulatory hurdles, especially with new GDP (good distribution practice) guidelines coming out, clients are looking to understand what it means, she added. Real time access to data is also important for clients, especially as companies want full access on where drugs are.
Partnerships are also key – if a client needs to run a trial in the Dominican Republic, for instance, “we can see if there’s a partner available to work with and set up interface on real-time access. We need to know how to grow our network if there’s client demand,” she added, noting that’s especially important as CROs run more adaptive trials.
Wes Wheeler, CEO of Marken, commented, “An increasing focus on rare diseases requires the industry to recruit patients from a larger pool of countries across the globe. The increased complexity of the drugs themselves, many of which are temperature sensitive and of high value, tells us the service provided by a specialty courier such as Marken satisfies a critical need in the supply chain and the successful completion of each clinical trial.”