The phrase “supply chain” conjures images of something rigid, straightforward. Rarely, however, is this impression accurate, and it’s certainly never true in the field of clinical logistics, where challenges for complying with handling and shipping regulations for different countries are many and diverse: Investigational Medicinal Products (IMPs), biological samples, medical devices, point-of-care devices, bedside diagnostics and study-specific documents.
Managing IMPs and ancillary supplies is a complex and delicate process — one that’s subject to change at every stage. There’s also much at stake, from maintaining IMPs that represent millions of dollars in investment to the health of volunteers and patients involved in the trials and eventual treatments. It’s never just a simple matter of crating drugs and making sure the delivery label is correct.
The IMP supply chain involves demand calculation, supply forecast, customs clearance, global sourcing, inventory management and a host of other variables. If any are mismanaged or imprecision occurs, it could harm the outcome of the clinical trial or, worse, place the safety of patients at risk. Avoiding costly trial delays, reducing patient risk and maximizing the opportunity for a successful clinical trial requires a holistic plan, rapid adoption, and the formation of a reliable ecosystem of expert partners.
PLAN EVERY PART
Just as one weak link can break a chain, in this case it’s a chain that supplies the demand for complex, multinational, multi-center studies. A range of variables needs to be addressed for each study, including the quantity of drugs required throughout; shipping regulations of the country where the study is being conducted; optimum packaging configurations and conditions; the cost; and important considerations such as randomized trials, which impact how drugs are packaged, delivered and tracked.
In simple terms, planning starts with a bill of materials. This bill of materials is very important in the planning phase for developing a global distribution strategy. Creating and streamlining the supply chain processes in a study’s early stages improves communication, reduces the supply risk, ensures increased protocol compliance and increases quality/patient safety. An insufficient supply of medication and ancillary supplies available for patients at sites across the globe represents a huge risk to the entire clinical study/program, even if all other clinical operations are under control.
IMPs themselves demand a special type of handling. After all, they’re precious cargo. These experimental drugs represent years of discovery and analysis costing millions of dollars. Overproduction and oversupply can be as costly as underproduction and undersupply. IMPs are also extremely sensitive with expiration dates and, often, cold-storage needs. From an inventory log-in to a disabled delivery truck — errors result in a staggering loss of product and a significant increase in expense.
However, before any medication can be distributed, it must be labeled as per clinical trial and local regulatory agency requirements. Regulatory requirements can be particularly stringent, and include stipulations such as paper type, font, format and language style that. In fact, a study label often turns into a booklet.
Of course, there’s more than one market and set of regulations to navigate. Each country has its own regulations. Failure to follow them will delay clinical trial supplies because they will be held up by border officials requiring correct documentation. Completion of import/export documentation requires expert knowledge that must be constantly updated as regulations continuously change.
Some countries even ban certain materials used in clinical trials, particularly in the area of gene therapy. When developing a patient recruitment strategy, experts in clinical logistics can provide invaluable advice on country selection to avoid these situations.
While protecting and delivering IMPs is the core job of clinical logistics, other facets of the IMP supply chain are equally important. A set of components too often overlooked is ancillary supplies. For every vital IMP that must be distributed there is a bevy of non-drug materials that need to accompany it and remain replenished. This includes printing material, patient diaries, lab instruments, medical equipment and incentives for volunteers and staff.
Trials are becoming more complex, so the amount of ancillary supplies and the number of vendors providing those supplies has greatly increased. As a result, ancillary supplies are traditionally managed in a way that results in their arrival from different places at different times. Unfortunately, this approach increases project management time and costs, leads to higher material and shipping costs, and creates complex, suboptimal processes that result in higher failure rates.
A better approach is to consolidate as many non-drug-related outbound activities as possible. In other words, institute a material flow that can be centrally managed. This approach yields significant shipping cost savings, time and process efficiency, and inventory transparency.
PLAN TO BE FLEXIBLE
However, having every component mapped, tracked and organized is not enough. Moving them becomes the next concern. Demand isn’t stable in clinical trials. It’s based on the original operational plan of a clinical study, which changes over the course of planning and execution.
Demand impacts everything from the number of patients needed for the trial to IMP shelf life to depot management. Adequate flexibility has to be planned in advance so that when the components change, demand can be addressed quickly and appropriately.
However, it’s not only demand. At any stage, all elements and environments that have been so carefully coordinated could change, threatening the integrity of the entire supply chain. Clinical logistics is a discipline of surprises, requiring careful distinction between following SOPs and being flexible enough to accommodate changes. Of course, that flexibility should never come at the expense of control. Without control, the supply chain falls apart.