The pharmaceutical industry is accustomed to thinking of the clinical trial supply chain as having two distinct parts: the digital supply chain, meaning the technology required to manage and monitor drug inventory, and the physical supply chain, or the processes involved in preparing and shipping drug products from depots to sites. However, that delineation was created simply because most vendors supporting the industry provide only half of the equation.
The delineation between the digital and physical supply chain need not exist; in fact, ideally, it should not exist. The digital and physical aspects of the supply are inexorably linked across all phases of the trial, starting with forecast and moving onto the bulk input and preparation of finished goods ready to ship from the depot… to monitoring sites’ inventory and patient dispensing… to managing returns and accounting for the disposition of all products. The extent to which the supply chain technology and supporting services are integrated directly affects the amount of oversight, degree of alignment, number of custom system integrations, and level of risk involved in ensuring successful trial operations. The more coordinated the effort, the better the ability to meet the trial demands in a cost effective, streamlined way.
When trial sponsors turn to separate partners to support the digital and physical supply chain, they must necessarily commit to spending significant management and problem resolution time in serving as a go-between. The onus is on the sponsor to ensure that the lines of communication are open between all of the parties, which usually translates into more frequent meetings.
Alignment, Coordination, and Consistency
A common understanding of the strategy is essential to seeing that the IRT design, packaging design, and distribution strategy all are working together in a cohesive fashion. Costly inefficiencies creep in when elements are misaligned. Investigational Medicinal Product (IMP) may sit at the depot long before the IRT is configured, or vice versa. The IRT may generate shipments that are impractical for sites to cope with logistically or that are not in line with the average patient treatment needs. Each vendor may create its own, unrelated set of requirements that cannot be easily integrated with others, posing difficulties for supply monitoring and data analysis. And the list goes on.
A Virtuous Circle of Information
IRT systems do not automatically integrate with other trial systems used by separate vendors, yet it is essential that information flow freely across these systems. When multiple vendors support separate parts of the overall supply chain, such integrations must be custom-designed for each individual study. This can be a costly and time-consuming proposition, easily adding tens of thousands of dollars to the system development costs of each study.
Improved Visibility for Inventory Management
It is critical for the supply chain manager to have insight into the demand for drug products (based on patient activities) as well as into current inventory levels. When a single reporting system draws upon clinical operations information and inventory details from the IRT, the supply chain manager can ensure that sufficient supplies are on hand for patients’ needs. Visibility into both sides of the demand / supply equation is especially important in order to accommodate unscheduled patient visits or the need to replace drug kits.
Every trial has hundreds of moving parts and an attendant high risk of something not going as planned. The risks are higher, however, when different partners provide different parts of the supply chain support. These include the risk that:
• Objectives, priorities, and schedules are misaligned, leading to costly mistakes and protracted timelines
• Information transferred manually can be incorrect and outdated
• The number of change orders increases with inconsistencies and discrepancies between vendors
• Stockouts and / or product wastage can occur from lack of visibility to the full supply chain
• Additional custom system integrations can add unforeseen costs
End-to-end supply chain solutions that encompass technology and supply chain management and distribution services actually improve study efficiencies that translate into savings. When the same partner provides the trial forecast, the drug supply strategy, the interactive response technology, and the packaging design and distribution services, the study benefits from a virtuous cycle of information and coordination. Processes all up and down the supply chain are optimized to ensure that the right drug is on hand at sites at the right time.