Time-sensitive shipments go further
pharmafile | December 18, 2009 | Feature | Manufacturing and Production |
The logistical challenges of transporting clinical trials samples over long distances are
rapidly being overcome, says Sue Lee, Manager of Biopharm Systems, R&D for World Courier.
Founded in 1969, in response to industry’s need for faster and more
controlled delivery of critical business documents worldwide, World Courier extended its expertise in time-sensitive transportation to the pharmaceutical industry in the early 1980s.
Since then World Courier has developed its services, delivering customised transportation and logistical solutions to companies in the biomedical, biopharmaceutical and high-tech sectors. Over 140 offices are located in 50 countries, on six continents,
including emerging locations in China, India and South-East Asia.
Changes in the set-up of trials
Ten years ago many clinical trials were performed in Western Europe and North
America. Transporting clinical trial materials (CTMs) was a small part of our business,
as many destinations could be served by road within Europe within 24 to 48 hours.
Most clinical samples were sent with refrigerated gel packs with what seemed to be a
hope and a prayer that they would remain at an appropriate temperature for the duration
of the shipment.
About eight years ago the first clinical trials started to happen in Eastern Europe,
inside countries such as Poland and the Czech Republic, which at the time were
outside the EU and still required customs clearance for all inbound and outbound
shipments. Setting up routes, customs brokers and offices in those emerging countries
was a logistical challenge.
Now we are moving into another phase with the new emerging markets of South
America and Asia, particularly China and India. Trials are happening in exotic places,
with unpronounceable names, previously only seen in geography books.
In some of these countries, export permits are required for every individual shipment
of samples. With the increasingly tight deadlines, and longer transit times to central
laboratories, due to sheer physical distance, the additional burden of customs export
clearance puts greater requirements on to the site to ensure compliance with collection
times. Being able to contact a local office, whose staff have direct knowledge of the
local weather and traffic conditions, as well as speaking English and local languages, can make a huge difference in achieving on-time shipments.
Regulatory enforcement, particularly since the implementation of the European Clinical
Trials Directive in 2004, has increased the demand for validated and qualified packaging,
and temperature monitoring of all clinicaltrial supply shipments and many clinical
samples. World Courier has responded to these challenges by sourcing regional
packaging options, suited to both local and international conditions, and capable of
withstanding the rigours of normal transport.
More than 120 offices are equipped with interfaces to read temperature monitors
and to allow a download of TempTales, as well as Elpro and similar, thereby permitting
quicker release of drug supplies, which can be vital in competitive recruitment trials.
Standard operating procedures cover almost every aspect of the business, which gives a
uniform and consistent service.
In contrast, changes in the regulations for shipping patient samples have meant that it
has become much simpler to ship samples from infectious patients, for example those
with HIV, using regulated packaging, but without the requirements for dangerous
goods paperwork.
The growth in the shipping of CTMs has brought its own challenges, with a move away from single shipments to much heavier loads going into depots, for onward distribution. These can range from a pallet, right up to a full chartered jumbo freight flight. More robust packaging is used on regular basis, from the Vacuum Insulated Panel boxes created by World Courier Germany to large temperature-controlled unit load devices which can both cool and heat, depending on the external temperature.
We have seen an end to the days when a routine shipment was a single box, with simple
documentation to an investigator site. Now bulk shipments are the norm, requiring
detailed set-up, and potentially five or more statements or documents, including permits, certificates of analysis and origin, and different statements for each authority in the US!
What does the future hold?
We expect greater requirements for reusable packaging, more recycling and less waste,
in line with many other industries. Radio Frequently Identifying Frequency (RFID)
tags and Global Positioning System (GPS) monitors are expected to change the way
that everyone looks at monitoring and realtime tracking of the locations of shipments.
Examples that can monitor temperature and humidity are already on the market, with expensive static hardware for reading off data. Change will be speeded by regulatory moves and individual airlines buying into the necessity for global tracking, combined with reductions in cost per unit and the introduction of hand-held completelyportable units.
It is likely to take a while for China and India to become saturated with clinical
trials, but already trials are setting up in the Middle East and Africa. More and more
remote locations are being used and the logistical problems involved in making
deliveries of CTMs and collecting patient samples are sometimes extremely challenging.
World Courier is ready to respond with offices and staff in those countries to ensure
a service that no one else can deliver.
