From Depot to Dose: The Power of RTSM Integration in Temperature Excursion Management

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At CTS Europe 2025, held February 24-26 in Barcelona, Endpoint Clinical and our partners at Sensitech | Berlinger presented on the future of temperature excursion management in clinical trials. This blog recaps our session, where we explored how integrating Randomization and Trial Supply Management (RTSM)systems with real-time temperature monitoring is helping sponsors protect product integrity, reduce operational burden, and maintain continuous patient access as clinical supply chains become more complex.

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Why Temperature Excursion Management Matters

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Temperature excursions pose a significant risk to clinical trial success. Even minor deviations can compromise drug stability, leading to delays, increased costs, and potential risks to patient safety. Traditional approaches, which often rely on manual processes and disconnected systems, make it difficult for teams to respond quickly and confidently.

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By integrating RTSM with temperature monitoring solutions like Sensitech |Berlinger’s SmartView, sponsors can:

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• Detect excursions instantly and trigger automated workflows
• Minimize manual effort while improving accuracy and compliance
• Optimize supply logistics to prevent unnecessary drug wastage

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How RTSM Integration Enhances Clinical Supply Management

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A fully integrated RTSM and temperature monitoring system gives study teams real-time oversight across the supply chain, from depot to patient. This proactive visibility helps teams make faster, more informed decisions to keep clinical supplies moving.

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Key benefits include:

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• Automated Monitoring and Response: When SmartView detects an excursion, an alert is sent directly to the RTSM. This allows immediate action, such as quarantining affected kits, notifying sites, and triggering resupply if needed.
• ‍Optimized Resupply and Reduced Waste: With real-time insight into shipment conditions and kit status, teams can prevent unnecessary disposal of viable products and improve inventory planning.‍
• Improved Site Support and Patient Access: Automated temperature tracking and stability budget management reduce the workload for site staff, freeing them up to focus on patient care instead of manual reporting.

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Real-World Results: Smarter Supply Chain Decisions

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Managing temperature excursions can be a significant operational burden. In one recent study, more than 1,800 shipments were monitored, with 79 excursions requiring 702 hours of manual work and costing €120,500 to manage.

After integrating RTSM with SmartView, the process became far more efficient. Non-critical excursions were automatically resolved, reducing manual work load to just 21 hours and cutting costs to €6,400—a dramatic improvement in both time and resources.

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Best Practices for RTSM Integration in Temperature Monitoring

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• ‍Start Integration Early: Align RTSM and temperature monitoring at the beginning of the trial to ensure visibility from depot to site and beyond.‍
• Automate Wherever Possible: Use real-time alerts, automated decision trees, and proactive site notifications to reduce manual processes and avoid delays.
•  Use Data to Continuously Improve: Leverage temperature and shipment data to identify risk areas, optimize shipping routes, and manage stability budgets.

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Looking Ahead

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Real-time, data-driven supply chain management is becoming essential as clinical trials grow in complexity. RTSM integration is no longer just a “nice to have”—it’s key to improving operational efficiency, meeting regulatory requirements, and ensuring patients receive safe, effective treatments without interruption.

Contactus to learn how Endpoint Clinical and our partners at Sensitech | Berlinger cansupport your clinical supply strategy. Request a demo today.

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