By Jonathan Cousins and Claire Voigt
The pharmaceutical industry’s current drug development system is “in crisis and unsustainable”, according to the Clinical Trials Transformation Initiative (CTTI), a public-private partnership in the US to improve the quality and efficiency of clinical trials.1 The organization has, over the past few years, issued multiple sound recommendations for Sponsors and Contract Research Organizations (CROs) on a range of trial processes—from recruitment planning to data monitoring.
Meanwhile, Sponsors and CROs are actively pursuing various trial innovations that can ultimately lead to a competitive advantage in the market. However, there is a frequent source of inefficiency in clinical trial operations that is often overlooked: the lack of coordination between the digital and the physical supply chain of drug delivery to trial sites.
The integrated supply chain
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. That delineation was created—and is now perpetuated—not for any process-related reason, but rather 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; 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. There are significant interdependencies between the Interactive Response Technology (IRT) and the management services needed to ensure that the right drug is available at the right site at the right time, and for the lowest cost.
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. A greater coordinated effort will lead to more visibility into what is happening and thus enable the trial manager to meet the trial demands in a more cost-effective, streamlined way. Conversely, executing the optimal supply chain strategy is more difficult, expensive, and time-consuming when different vendors are working independently.
When trial Sponsors turn to separate partners to support the digital and physical supply chain, they must necessarily commit to spending significant management time 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.
Having multiple vendors also contributes to a fragmented financial picture. As explained by Heather Schultz in an Applied Clinical Trials article, “Multiple vendors and contracts end up in disparate systems, and the lack of integration doesn’t allow that data to be brought together for financial management in an easy or efficient way, making forecasting and budgeting extremely challenging.”
The complexity of problem resolution also increases with the number of vendors involved in the project. Multiple information sources and the limited view of each vendor make root cause analysis difficult. Also, it is easy for individual vendors to lapse into absolving themselves, pinning the “blame” for issues on others.
Finding a workable resolution can, therefore, be frustrating and time-consuming. In contrast, when a single vendor team is involved throughout the project, there can be a single, cross-team escalation pathway that tends to speed problem resolution.
Alignment, coordination, and consistency
The above project oversight issue has easy remedies but can require costly investment with the help of additional management resources. However, the need to ensure that all parties are in alignment and are working toward a common goal using consistent approaches is a much more serious matter.
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 arise 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’s 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.
Vendor responsibility is limited to the portion of the overall trial they have visibility to. Therefore, ensuring that overarching protocol objectives are met rests with the study Sponsor. Ensuring that cross-discipline goals, timelines, processes, and deliverables align across vendors is a time-consuming and challenging endeavor. Efficiencies in Clinical Trial delivery translate into increased quality and decreased cost.
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