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International Clinical Trials

The Last Mile

The global pharmaceutical industry spent more than $8 billion on cold chain logistics in 2014, getting their products and clinical trial supplies into pharmacies and hospitals worldwide. It is a similar picture this year: millions of miles will be travelled under the GxP regulations, with every consignment controlled for the correct storage conditions – including temperature and, sometimes, light levels and humidity. The drug then arrives at 'the last mile', a phrase that can strike fear into the hearts of project managers and supply chain professionals. This is the point at which the product, at a local level, gets to the ultimate users, which may be the investigator site, patient’s bedside or home address.

Stages of the Journey

Particularly with lifesaving medication or chemotherapy, the patient may be sitting in a hospital bed waiting for their treatment, and that final mile can be make or break. However, the first mile can be equally important. Modern treatment regimes regularly take cells, blood or biopsies from a patient and transport them to a laboratory for analysis, after which patient-specific treatments are created. These are not on-the-shelf solutions that can be replaced in the event of a problem with shipping. At best, another set of patient samples would have to be taken, transported and analysed, with the accompanying delays. At worst, there is no way to replicate and provide a therapeutic agent.

Moreover, there is not just one last mile; it depends on who you speak to, and whereabouts in the world they are. The developed world has sophisticated distribution systems, but getting a vaccine or other temperaturecontrolled materials to sites in developing countries is a much more difficult proposition, requiring control and excellent communications to make the necessary arrangements.

Systems and Technology

There is often a time element involved, and usually technology utilising temperature monitors and interactive response technology registration. A variety of tools are available to help – for instance, cloud-based systems for uploading data directly at the consignee can make all the difference.

Differentiating between the macro and micro levels is crucial. Global positioning systems can be used during transport, monitoring and transmitting the location of the temperature-controlled package. In addition, geo-temp technology is a promising innovation that could be developed for cold chain use in future. More traditional TempTale or Elpro device remain widely used.

Best Laid Plans

Systems need to be put in place well in advance of shipping so that the critical control points and handovers are both understood and effectively monitored. Ensuring that the ultimate consignee understands their responsibilities in downloading temperature monitors and dealing with the materials when they arrive is essential for the success of the shipment. Having spent time and budget delivering to the site, all can be lost if the material is left out at room temperature in an office, or placed into the wrong storage area where conditions are hostile. Preplanning and communication are essential. Even the best laid plans can go wrong – due to circumstances beyond your control – requiring flexibility from all parties that are involved in the supply chain.

Homecare can provide the data and peace of mind; delivering the medication under controlled temperature to a healthcare professional. They can be ready to administer the infusion or injection to the patient, averting the need for them to travel to the hospital. With medication then stored in the home, special fridges can be used which restrict access without a passcode – protecting other family members and even pets from inadvertent use. For materials which are not temperature controlled, technology can be employed to check when the patient opens the bottle.

Intelligent Solutions

The last mile makes all the difference to the consumer, and it is the only thing they will see, as the rest of the supply chain is – and should be – hidden to them. Even the best-designed supply chain is worth little if it all goes wrong at the delivery hand-off. Solutions which are appropriate to the destination, drug and patient must be employed in an intelligent manner to ensure compliance.

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Sue Lee, Technical Portfolio Manager, has worked for World Courier for 25 years. During this time, she has experienced a variety of customer service and operational functions, including the setting up of numerous multinational clinical sites for the transportation of biological samples. Sue has orchestrated thousands of shipments with very specific temperature requirements to a host of challenging locations, each presenting their own obstacles and dilemmas.
Sue Lee
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