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Applied Clinical Trials
What you need to know to save the bottom line...and your sanity.
When you are in the business of creating lifesaving drugs, the mundane details of shipping logistics is not usually the first concern that springs to mind.
The biopharmaceutical industry, by its very nature, is one in which underlying business operations are often perceived as secondary to the higher calling of treating or even curing some of the most devastating diseases on earth. But ensuring that clinical samples reach their destination safely, securely, and at the right temperature is just as crucial as any element of the drug discovery process.
This is not hyperbole. Consider the following statement from the Medicines and Healthcare Regulatory Agency (MHRA):
Observance of the principles and guidelines of good distribution practice helps ensure that good practice applied during the development, testing and manufacture of medicines is not erased by the actions and omissions of those organizations involved in their distribution.
In other words, shipping logistics should be treated with the same seriousness and be subject to the same vigorous standards that laboratories, pharmaceutical sponsors, and independent clinics devote to their scientific research.
For most companies, contracting with a specialty courier is the best way to ensure desired results. But there are a series of issues that trial sponsors should be familiar with before choosing its courier service. Basic knowledge of federal and international regulations is not enough. Your courier will have to anticipate the types of shipping containers to be used, the distribution carriers to be contacted, local rules and customs, local environmental conditions, how to ensure the length and time of the distribution route, and much more.
As a trial sponsor, your knowledge of the following basic facts will ensure that your "cold chain" runs as efficiently as possible. (Cold or cool chain is a generic term that refers to all the storage, transport, paperwork, and logistical capabilities needed to ship a product requiring controlled low-temperature storage.)
It is imperative that your courier representative is brought into the clinical trials shipping process as early as possible. This is part and parcel of looking at the shipping process not as an afterthought, but as an integrated part of the drug discovery process. Early on, the courier can begin to implement the protocols at origins and destination points to ensure consistency throughout the logistics supply chain.
A smart courier realizes that commercial airlines are often the most cost-effective carriers of clinical specimens and investigational drugs. With sufficient lead-time, the courier can select ideal routings and pick-up times to provide the fastest door-to-door transit time. Plus, every airline's capabilities will need to be analyzed to ensure that they have appropriate infrastructure and awareness of the effect that temperature variances can have on the goods they are transporting. A courier specializing in temperature-controlled transportation will be able to select the carriers with the best capabilities to handle these shipments.
And of course, the earlier a courier gets involved, the easier it will be to establish the most important element of the shipping process: lines of communication. This will ensure that all the players in the process have up-to-date information on the progress of a specimen or study drug shipment. Plus, if something goes wrong—remember Murphy's law—the courier will know exactly who to contact.
The transport of human clinical trial samples and investigational drugs are highly regulated by both national and international transportation law. The basic precept of United Nations and most governmental decrees is that transport workers, airline passengers, and the general public must be warned about and protected from any possible infection from contact with human bodily fluids leaking outside of their packaging. Since most of the samples travel by air, the International Air Transportation Association (IATA) Dangerous Goods Regulations, which take their cue from the United Nations, must be consulted. Compliance with the rules are mandatory.
Just when clinical research associates, doctors, nurses, technicians, and logistics planners feel they finally have a handle on how to conduct the transport process, they are annually faced with new regulations. The year 2005 is no exception. This year, significant new regulations have mandated changes in how diagnostic specimens and investigational drugs are classified, and how packages are marked for transport purposes.
Failure to comply with the new rules could result in the collapse of the clinical trial process: airlines will refuse to accept the patient samples for carriage. However, this potential disaster can be avoided through careful attention to the transport regulatory environment during the planning process.
Quality air carriers usually do their best to accommodate the needs of shippers transporting biological material. But a courier will still need to have intimate knowledge of each carrier's SOPs. This is one piece of due diligence that can prepare you for the uncertainty of dealing internationally.
At any given time of the year, the regulation environment can vary greatly from country to country, or even within the same country. There may also be state and operator variations of the regulations that impose greater restrictions on shippers. Working closely with your courier will allow you to plan around these variations, to minimize their impact on the clinical logistics process. But clinical trials occur everywhere. It is now common for three different components of a clinical trial to take part in three different parts of the world.
Trials occurring in developing nations present an entirely new set of challenges. When operating in these areas you may be forced to deal with:
Only a courier who possesses in-depth knowledge of these local issues and customs will be able to navigate your shipments through the process easily.
When it comes to maintaining the integrity of clinical specimens and investigational drugs, temperature and time are the two enemies that are always working against you. Creating adequate safeguards to protect this critical cargo is itself a science.
Ambient specimens present challenges, as they may have a specific time element in transit. However, most challenging are clinical specimens or investigational drugs that either need to be frozen at -78.5 degrees Centigrade or maintain refrigerated temperatures between 2-8 degrees. Temperature variations of just a few degrees can affect integrity of specimens or investigational drugs and result in thousands of dollars in costs, and the wasting of priceless time. More ominously, if this mistake were to go undetected, it could ultimately cause harm to patients involved with the clinical trial. To achieve temperature consistency of specimens and/or investigational drugs, your courier, lab or drug packaging vendor will have to:
Whether or not you can maintain your desired temperature will be dictated by how well time is managed. Biological shipments will always be scrutinized by motor carriers and airlines that need to protect themselves when they briefly assume responsibility for a shipment. As noted above, flawed paperwork is an easy way to doom your shipment. But another is packaging and labeling mistakes.
Each link in the shipping chain, from the clinic to drivers to airport personnel, must ensure the integrity of each package. Rips, dents, and tears will halt the shipping process. Diagnostic specimens and drugs that may be classified as dangerous goods must also always be clearly marked and labeled. The labels must be intact and properly placed, and they must accurately represent the shipping classification of the shipment.
If any of these conditions are not met, you will find yourself sending a certified lab representative to fix the problem, or forking over a substantial amount of cash to have a licensed packaging company do it for you. But by then, it may already be too late.
Finding the right courier to shepherd your clinical specimens will keep your trial running smoothly—and that will save you money. There are explicit things a courier can do towards that end, such as bundling shipments from multiple in-country sites. But the real cost savings comes from your courier not losing you money. Staying one step ahead of regulators, investing in new technology, and having redundancies and complex backup plans to deal with any contingency is how couriers can truly save your sanity—and your bottom line.
Dan Catizone is vice president of business development, QuickSTAT, (732) 544-0401, email: email@example.com, www.qicstat.com.