Without clinical trials, potentially life-saving drugs, therapies, and other medical and surgical interventions would never reach patients. But if they’re not backed by reliable supply chains, these trials might never get beyond their initial phases.
Unfortunately, managing the clinical research supply chain is growing more difficult every year. As a result, researchers and supply chain managers need to work together to anticipate potential challenges before trials get underway—or else risk costly and time-consuming setbacks.
Specialized delivery solutions are essential to maintain compliance, ensure product integrity, and protect patients
As clinical research advances and investigational products grow more sophisticated, increasingly specialized delivery solutions are required for transporting products and materials safely to testing sites.
For example, the rise in biologic active pharmaceutical ingredients (APIs) has driven a greater demand for light- and temperature-controlled trucks due to the sensitivity of these materials. Many cell-based products even require cryogenic conditions in order to perform optimally throughout clinical trials. And since clinical trials are subject to Good Distribution Practice (GDP) and Good Clinical Practice (GCP) regulations, the transportation, handling, and storage of all products are subject to close scrutiny.
This poses a challenge for supply chain managers since many commercial carriers cannot accommodate such stringent requirements. Carefully vetting carriers is critical to both the success of the trial—and patient safety.
A nimble approach is required to prevent costly product overages
As pharmaceutical research trends toward biologics and large molecule APIs, researchers and supply chain managers are under increased pressure to conserve investigational products and reduce waste. These materials are not only more expensive and difficult to produce in large quantities than small molecule products, but have shorter expiry dates, are less stable, and require more complex—and therefore expensive—shipping solutions.
While researchers might once have ordered in bulk and saved excess product for future campaigns, it’s now imperative to order the right amount at the right time to ensure it doesn’t expire or go to waste. This is complicated by the unpredictable nature of clinical trials, with some participants dropping out before the trial even gets underway, and numbers continuing to thin as studies progress.
To prevent overstock while still ensuring they have enough product to meet patient demand, supply chain managers need to get more nimble with their planning and purchasing, making adjustments on the fly rather than setting plans in stone months before a study begins. For this approach to work, however, they must have confidence that their carrier network is up to the task of delivering materials on time and in optimal condition—otherwise, trial delays are inevitable.
The smallest disruption in the supply chain can greatly impact a trial’s results
While demand-led planning can prevent costly overstock, it can also leave clinical supply chains more vulnerable to disruption. Having too much product is an expensive problem, but having too little can result in data becoming invalidated if patients miss even one dosage.
To bolster their supply chains and prevent broken links from sinking entire studies, supply chain managers need to engage in strategic comparator sourcing and plan for any eventuality. If a product is being shipped internationally, are there local suppliers that could meet demand in a pinch, or vice versa? And if so, are there alternative carriers on hand that could move that product in a safe, timely, cost-effective, and compliant fashion?
Supporting clinical trials, fueling transformative research
At CTSI-Global, we understand the challenges of clinical trials—and the possibilities. That’s why we’re dedicated to helping teams navigate the complexities of the clinical supply chain to bring the future of medicine one step closer.
Through our proprietary technology, deep industry relationships, and decades of expertise, we can help supply chain managers to quickly identify the logistics solutions that meet the exacting needs of their studies. Our 20,000-strong global network of fully vetted carriers includes major cold chain operators with vast experience moving short-dated and highly regulated clinical materials, so you can feel confident about finding capacity, no matter how sensitive an investigational product is.
Strengthen the backbone of your clinical trials. Find expert logistics solutions and supply chain support by contacting CTSI-Global today.