Scott Houlton, CEO
Launching a new drug into the global market has become a challenging task for drug manufacturers due to various regulatory requirements, new technologies, and the complexity of studies being conducted. As such, the need for smart and accurate clinical supply chain management decisions along with detailed monitoring, precise planning, and coordination between many players has become a critical aspect. Enter CSM, an all-in-one clinical supply chain solution company that focuses on providing innovative ways to overcome the challenges of the supply chain of pharmaceutical and biotechnology companies around the globe. “We make shipments to over 85 countries across the globe and have to ensure that right medicines are shipped to the right patients at the appropriate time,” asserts Scott Houlton, the CEO of CSM.
The dynamic nature of clinical trials can lead to unforeseeable outcomes and process changes which demands a flexible supply chain implementation. This is where CSM stands tall as compared to their competitors in the market. The company has expertise, which caters to their customers in managing inventory and distributing drugs so that the clinical trials become more efficient and reliable. Additionally, they not only help their clients in the global distribution of the products but also assist them throughout the material movement process to maintain the appropriate temperatures for the medicines. “CSM has a strong, 20 year track record and we understand the regulatory guidelines around the world. Our project management expertise works with our customers to actively manage planning and acquire the techniques to optimize the process of the clinical trials,” says Houlton.
CSM’s unique On-Demand services provide sponsors with versatile and innovative tools that enable their clinical trials to run on expedited timelines and dramatically reduce the overall cost of trial supply when compared to traditional supply chain solutions.
We do shipments across the globe and have to make sure that right medicines are shipped to the right patients at the appropriate time
On average, over 50 percent of clinical supplies packaged using a traditional approach are never utilized. On-Demand packaging and labeling of clinical supplies eliminates this waste, which allows customers to save more than what they spent to package the entire clinical trial. In one such instance, a sponsor requested an urgent packaging and labeling of an investigational medicinal product (IMP) to Belgium, within a limited period of 48 hours. In addition to that, the sponsor had no additional stock of the drug product available and would have to repurpose the drug product from another trial with the same product. Also, as the shipment destination was within the EU, there were regulations that required certification by a Qualified Person (QP) for each packaged batch, leading to an additional constraint to the delivery procedure. By using the On-Demand methodology, CSM helped the sponsor overcome each of these issues. They packaged and labeled the exact number of kits needed, and dispatched them immediately, without warehousing, to the site. A team was assigned for handling the request,and the process also involved QPs to ensure that the batch certification was completed within the time limit.
Also, CSM has designed a Direct-to-Patient program which can be customized as per the requirements of the patients. To enable faster and hassle-free services, the company utilizes combined commercial flights with courier services for Direct-to-Patient delivery instead of using a standard freight integrator with a shipping schedule. Furthermore, a TSA-certified cargo screening facility ensures that each shipment is fully inspected before leaving CSM in order to avoid a delay in another inspection process.
The recent acquisition of CSM by UK based company Clinigen Group Plc (LON:CLIN) will enable CSM to expand their footprints across South Africa, Australia, New Zealand, Singapore, Hong Kong, and Japan. “It provides CSM an expanded global footprint to benefit our customers and creates a specialist Global infrastructure to the benefit of patients,” concludes Houlton.