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Clinical Trial Temperature Management

Streamlined Cold Chain Compliance & Safety

Ensuring every patient receives safe, effective treatment starts with protecting each drug kit throughout the clinical trial journey. Our automated, end-to-end temperature management system goes beyond tracking single excursions — it monitors stability across the entire supply chain, so issues are detected and addressed before they become risks.

By connecting sponsors, CROs, CDMOs, and clinical sites in one streamlined platform, we help you safeguard patient safety, improve compliance, and drive greater efficiency in the delivery of today’s most advanced therapies, from biologics to cell and gene treatments.

Berlinger SmartView Cloud Analytics Software for Clinical Trials

From Risk to Resilience: Monitoring Temperature in Clinical Trials

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Protect product integrity and patient safety
Even minor temperature excursions can compromise sensitive therapies, creating compliance risks and endangering patients.
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Avoid costly delays and waste
Small deviations can result in discarded inventory, shipment delays, and higher trial costs.
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Act instantly with real-time visibility
Automated monitoring detects excursions as they happen, enabling swift corrective action.
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Streamline operations through integration
Our extended ecosystem connects with RTSM systems, automating temperature management across the supply chain.

Tailored Solutions for Every Stage of Clinical Trials

Stationary USB Monitoring

  • Compliant cloud storage with automated data collection
  • Excursion alerts and location data for root cause analysis
  • Accept/reject shipment decisions with aggregated reporting
  • Fridge/freezer monitoring and basic segment analytics
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Real-time Stationary Monitoring

  • Continuous monitoring of storage environments in real time
  • Proactive issue detection for on-site drug kit management

Real-Time In-Transit Monitoring

  • Continuous visibility into shipment location and condition
  • Segment-focused tracking for faster root cause identification
  • Real-time alerts to enable rapid corrective action
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End-to-End Real-Time Monitoring

  • Automated management of temperature stability across the supply chain
  • Focus on stability budget breaches rather than individual excursions
  • Easier audit reporting and compliance
  • Streamlined collaboration between sponsors, CROs, CDMOs, and clinical sites

Partnerships

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Endpoint Clinical
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4G Clinical

SmartView + RTSM: The Golden Combination

SmartView integrates seamlessly with leading RTSM systems to deliver full automation in temperature management. By working together, RTSM remains your primary system of record while SmartView ensures every step of the cold chain is monitored, compliant, and reliable.

Benefits of Partnering with Us

  • Full automation of temperature monitoring within your RTSM workflow
  • Improved compliance and audit readiness through integrated data
  • Streamlined processes that reduce manual workload and errors
  • Added value for RTSM providers seeking to strengthen their clinical trial offerings

Contact Our Partnership Team

We are always looking to collaborate with RTSM providers and other ecosystem partners who want to deliver greater efficiency and safety in clinical trials.

Interested in exploring a partnership? Reach out to us today.

Case Studies

During clinical trials of Investigational Medicinal Products (IMPs), sponsors and caregivers are focused on patient health, not on managing cumbersome and time-consuming temperature monitoring systems. Learn how leading global pharmaceutical companies have partnered with Sensitech to ensure compliance, speed and patient safety with simple and intuitive monitoring solutions.

Learn More: Clinical Trials – Storage of Medicines


Case Study: Merck KGaA & Berlinger

Challenge

In a typical clinical trial, Merck KGaA experienced:

  • 21 temperature breaches
  • 110 temperature excursions
  • Resulting in more than 700 manual hours spent on investigation and documentation

Solution

By implementing an End-to-End (E2E) temperature management solution with Berlinger’s SmartView, Merck KGaA was able to automate excursion handling, streamline reporting, and focus only on true stability breaches.

Results

  • Manual workload reduced from 700 hours to just 21 hours
  • Average savings of 689 hours per trial
  • Simplified audit readiness and improved efficiency across teams

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Case Study: Debiopharm and Berlinger

From Temperature to Full Condition Monitoring - Berlinger had the privilege of implementing SmartSystem for shipment monitoring in a Debiopharm trial as a pilot project. This case study delves into the challenges faced, the innovative solutions deployed, and the tangible impact observed during the trial. The Debiopharm trial, characterized by its first-in-class approach, demanded an extra layer of precision and care in managing the investigational products.

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