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Clinical trial study credibility is about more than just a well-designed study protocol
Trade wars, fluctuating customs regulations, pandemics, blizzards, large boats getting stuck in canals. Predictable or not, any one of these events occurring almost anywhere in the world has the potential to jeopardize the credibility of a pivotal clinical trial by disrupting the global supply chain and slowing the delivery of time-sensitive study medication.
Regardless of the underlying cause, delays of any kind can threaten treatment timelines for participating patients and have the potential to cast a shadow over a study’s success.
The complexity of today’s global supply chains means there are many persistent opportunities for supply chain disruption. A built-for-purpose RTSM system provides much-needed support to clinical trial procurement professionals and supply managers grappling with the complications of distributing time-sensitive medications and adhering to complex study protocols.
Here are just a few ways selecting the right RTSM partner early in your study design can support the future credibility of your study.
One of the main advantages of an RTSM system is automation. Customizable inventory functions and predictive algorithms offer a flexible toolkit to optimize drug supply management. They provide control over initial shipment quantities, threshold values, DNX parameters (i.e. Do Not Dispense, Do Not Include, Do Not Ship), and the dynamic adjustment of expiration dates. Additionally, the system predicts adequate drug supply for future appointments and maintains appropriate levels of surplus for unforeseen circumstances like new enrollees or unscheduled visits. When used effectively, these tools can also minimize waste by ensuring precise quantities and orchestrating timely deliveries, aligning seamlessly with trial requirements.
An RTSM system fully integrated with eClinical technologies, depots, and temperature monitoring systems, allows for maximum oversight. Without manual intervention, the RTSM system will send shipment requests to the depot where the depot seamlessly updates dispatch details to the RTSM. Integrations like this improve data accuracy and integrity and eliminate manual transactions that could introduce errors and shipment delays.
Supply chain disruptions don’t only occur during business hours. Real-time supply monitoring allows for rapid and effective response to unforeseen challenges. A robust RTSM system flags incidents and triggers alerts, enabling swift intervention to avert trial interruptions. Customized, real-time reports offer a live feed of information on shipment requests and tracking, which can be complemented with ad hoc reports. Notifications and alerts for things like shipments, temperature excursions, and site inventory availability can be shared across a group of stakeholders so that everyone remains aware of critical developments.
RTSM systems enhance regulatory compliance and ensure the quality control required for a credible study. The system documents processes and subsequent corrective actions and provides a comprehensive traceability framework for internal review. The reports are there when you need them without committing hours of manual process documentation. By capturing the entire lifecycle of the drug, from release to shipments, assignment, and return, RTSM facilitates accountability and reconciliation within a validated system.
Your RTSM system can help you introduce new key performance indicators (KPIs) for monitoring shipping processes, and customs clearance allows supply chain managers to pinpoint and proactively rectify potential pitfalls at border crossings. Customizing your RTSM setup during the design phase by including the geographic locations of trial sites and possible customs delays allows the RTSM system to address potential issues through timely notifications, alerts, and strategic supply management.
RTSM systems have become an indispensable tool for better managing the clinical supply chain. But your RTSM is not just another piece of tech. Along with your RTSM support team, it is critical infrastructure in the pursuit of a well-run and credible clinical trial.
RTSM integration offers a comprehensive, real-time, and strategic approach to address existing supply-chain challenges while strengthening clinical supply chains against unforeseen obstacles.
RTSM aligns supply strategies, streamlines operations, optimizes supply management, maintains regulatory compliance, and provides data-driven insights, ultimately helping you reach your endpoint: a successful and credible clinical study.
With decades of experience, Endpoint Clinical is obsessed with proactive problem-solving, ensuring that issues are anticipated and resolved before they escalate, and any necessary changes are easily incorporated. From day one, we become an extension of your team, seamlessly integrating into your trial operations, minimizing friction, reducing risk, and enabling your clinical teams to focus where it matters most—on trial success.
Schedule a quick demo with Endpoint Clinical to learn more about how our solutions can optimize your clinical supply chain.
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