In terms of shipping and transportation, key issues to consider are the estimated travel time to given countries, a review
of the method of shipping (i.e., active, passive, phase-change), the type of transportation (i.e., air, ground, or ocean)
that will be used, validation of the shipper, and evaluation of the devices used in temperature monitoring. With respect to
shipper validation, shippers may fall into three categories: nonqualified (i.e., the shipper provides no documented testing
to maintain temperature), prequalified (i.e., the shipper performs documented testing to a shipping standard, such as water),
and validated (i.e., the shipper performs documented testing to a shipping standard with a given product). With respect to
monitoring, he noted that as part of the packaging decision, it has to be determined whether temperature monitors should be
used with all shipment or with some shipments. "All of these decisions affect cost and the quality of the product," says Gourley.
"The higher the cost of the delivery system, in general, the more robust."
Another decision point is kit size, noted Gourley. Freight costs are calculated on either the physical weight of the materials
or on the dimensional weight of the materials. Kit size will drive the shipping cost based on whichever of these two factors,
physical weight or dimensional weight, is greater. Reduced kit size will reduce the cost of shipment.
In these packaging and shipping decisions, packaging software can be used to reduce the size of the kit and to match the best
shipper for the intended application. "Before determining the final packaging configuration, however, you will need to know
how most material will be shipped and what type of cold-chain packaging will be used," he says.
With respect to security, Gourley emphasized the need to know the capabilities and practices of the shipper to ensure their
performance. Some key issues are whether the courier can screen materials, whether the courier has been audited, whether the
courier works with the consignee to clear shipments, and how the materials are handled in the couriers' presence.
In the end, adaptability is key. "With the trend toward more complex clinical trials, the ability to remain flexible and rapidly
adjust to changes in client demands has been a critical success factor for on-time delivery and receipt of clinical-trial
materials," says Randall H. Guthrie, vice-president of Xcelience. He points to the value of project management, integrated
supplier networks, and an understanding of regional differences from a regulatory standpoint to meet CTM requirements.
1. PhRMA, "Pharmaceutical Industry Profile 2011" (Washington DC, April 2011).
2. Tufts Center for the Study of Drug Development, "Rising Protocol Complexity, Execution Burden Varies Widely by Phase and
TA" Impact Report 12, No. 3, May/June 2010.
3. HHS, "Challenges to FDA's Ability toMonitor and Inspect Foreign Clinical Trials" (Washington DC, June 2010).
4. S.W. Glickman et al., N. Engl. J. Med.
360 (8), 816-823 (2009).
5. D. Gourley, presentation at the 9th Annual Cold Chain & Temperature Management Global Forum (Philadelphia, Sept. 2011).