All the elements of a clinical trial supply chain are, as the name indicates, closely linked together. Intelligent management of vital study medications and supplies is a formidable challenge, and a misstep could mean cost overruns, trial delays, and failure to get patients the drugs when needed.
Oliver Cunningham, vice president of supplies management with Signant Health, discussed the complexities of clinical supply chain management, and one tech solution designed to help streamline the process.
OSP: Could you please talk about some of the biggest/most formidable challenges trial professionals face when managing clinical trial logistics?
OC: The biggest risk for a clinical supplies team is not having the right medication on time for patients enrolled in the clinical trial. This is largely due to the lack of supply chain visibility, leading to poor forecasting and planning for ongoing and future needs, both at the manufacturing (program) and site (study) level.
Because the risk of a missed patient is so high, clinical supply teams typically resort to creating buffers by ordering more drugs than needed to avoid stock out. However, the demand generated from site recruitment is often unpredictable, and stock is frequently unable to be transferred between sites, resulting in many sites throwing away excess and expired stock – a particular concern for high-cost products with a short shelf life.
OSP: Similarly, what are some of the missteps (or maybe missed steps) logistics managers commonly make?
OC: Far too often, clinical supply teams forecast with spreadsheets that produce limited demand and supplies visibility. They also lack operational standardization, resulting in clinical trial delays, hidden costs, and drug waste. In addition, the nature of spreadsheets requires manual data input, which can lead to erroneous forecasting based on out-of-date data.
OSP: Please tell us about your SmartSignals solution—what it is, the applications/environments it’s best suited for, and an overview of the ways it helps study professionals streamline things.
OSP: SmartSignals Supplies is a cloud-based, enterprise solution, designed specifically to streamline the complexities of the clinical supply chain. The Supplies software serves life science companies with easy access to real-time demand and end-to-end inventory visibility within a single source.
A central repository for demand and supply metrics means clinical supply teams are more consistent and accurate in how they forecast and plan at both the study and program level. This can be a challenging scenario to imitate with traditional spreadsheets.
OSP: Specifically, please share how SmartSignals helps users collaborate and control aspects of their SC.
OC: Managing a clinical supply chain within a single environment establishes a common framework for forecasting, planning, and inventory management. A common framework builds organizational capability and expertise while encouraging collaboration since everyone is homogeneously trained using the same standard processes.
OSP: Could you please tell us about capabilities and features SmartSignals offers that other systems and solutions might not?
OC: SmartSignals Supplies is designed to provide customers with the ability to dynamically manage their clinical supply chain with end-to-end visibility and real-time data, so they can properly review current demand estimates, plan mid-study production runs, and accurately revise forecasts and production timings.
We’ve developed these capabilities over 20 years working with small to large pharmaceutical companies. During this time, the environment has evolved to meet the changing needs of our customers. This includes standard integrations with contract manufacturing organizations (CMOs) and distribution partners, scenario planning with version-controlled libraries to optimize supplies at all levels, advanced reporting capabilities with visually appealing, dynamic graphs, and fully compliant audit trails.
In addition to our extensive experience, SmartSignals Supplies looks for innovative ways to support our customers with a competitive advantage. These advantages include integrated temperature monitoring, built-in resilience to support new regulatory guidelines, and direct-to-patient (DtP) drug delivery.
OSP: Do you have anything to add?
OC: SmartSignals Supplies is a cloud-based, software-as-a-service solution, empowering companies of all sizes as it does not rely on an internal IT department to manage.
Our software is fully integrated with our SmartSignals RTSM solution, providing real-time logistics and usage data, ensuring accurate and up-to-date data are used at all times in ongoing supplies demand planning. The combination of the two also provides full visibility of the chain of custody for each medication unit and the full reconciliation, returns, and destruction process. This ensures full accountability without the need to reconcile multiple data sources.
Similarly, the management of upstream manufacturing and production processes with in-trial logistics enables Sponsors to consolidate and manage temperature excursion management across the complete lifetime of each medication unit.
Further integrations across our suite of products add additional power to the data. For example, patient consents within our eConsent solution provides screening numbers to RTSM, which the solution uses to determine site stock levels and account for new patients randomized.
SmartSignals Supplies also supports the increasingly popular DtP medication supply, which has applications in both traditional, fully site-based trials and hybrid trials where some or all patient assessments are remote. In addition to the added convenience for trial participants, controlling patient-level distribution of supplies from a central pharmacy or local country depot increases drug savings and reduces overall wastage, enabling studies to operate on less overall supplies and in some cases, start earlier.
