Future-Proofing Clinical Trials: How Sponsors Can Up-Scale Through Automation

At this year’s Clinical Trial Supply Europe event in Barcelona, TSS took center stage to discuss one of the most pressing challenges in clinical trial supply chains—temperature monitoring. Our Key Account Manager, Anita Leposa, highlighted how automation is revolutionizing temperature integrity management, reducing manual work, and ensuring compliance for global pharmaceutical sponsors.
Insights from Clinical Trial Supply Europe 2025

The Growing Challenges in Clinical Trial Supply Chains

As clinical trials become more complex and global, ensuring temperature integrity across the supply chain has become a significant bottleneck. Based on our experience working with major pharmaceutical companies, we’ve identified three primary pain points:

  • 1. Increased Complexity & Site Burden
    Clinical trials are expanding in scale, requiring faster execution while placing additional pressure on clinical sites to maintain strict temperature control.
  • 2. Manual & Reactive Processes
    Many sponsors still rely on outdated manual calculations and spreadsheets for temperature data, leading to inefficiencies and compliance risks.
  • 3. Lack of Real-Time Visibility
    Without digital integration, sponsors lack a clear view of temperature deviations across the supply chain, causing delays in decision-making and potential risks to patient safety.

The Power of Automation—From Days to Seconds

During the session, Anita engaged the audience with live poll questions, revealing that the majority of attendees struggle with real-time visibility and manual processes. This confirms what we see across the industry—organizations need smarter, automated solutions to stay compliant and efficient.

By leveraging automated temperature monitoring, our pharmaceutical clients have reported significant improvements, including:

  • Instant release decisions enabled with 94.9% of temperature excursions resolved automatically, avoiding unnecessary quarantine time.
  • Accelerated drug availability when more than 100,000 clinical kits, though affected by excursions, were cleared for use without delays, ensuring that critical medications reach patients on time.
  • Sponsor cost savings exceeding $5M annually with reduced excursion evaluation time, lower inventory holding costs, and improved resupply efficiency.

Where Does Your Organization Stand in the Digital Maturity Journey?

Not all sponsors are at the same stage of digital transformation. Some organizations still operate in silos, where manual data handling and slow deviation resolution create inefficiencies. Without proper integration, teams struggle to maintain visibility, leading to delays and compliance risks.

Others have started to integrate digital tools but still rely on manual reviews, limiting the speed and efficiency of their processes. While small improvements have been made, they are not enough to keep up with the growing complexity of clinical trials.

The most advanced sponsors have fully automated and integrated temperature monitoring systems. These organizations leverage predictive analytics to prevent excursions before they happen, ensuring faster, more efficient decision-making and improved compliance across the entire supply chain.

Seamless Integrations for Smarter Supply Chains

TSS provides a hardware-agnostic, fully integrated solution that ensures:

  • Real-time temperature tracking across the entire supply chain, from manufacturing to dispensing at clinical sites.
  • Automated decision-making, eliminating manual calculations and reducing the risk of errors.
  • Predictive analytics to prevent temperature excursions before they impact clinical trial timelines.

Our bi-directional integration with RTSM, CTMS, and inventory management systems ensures faster drug releases while maintaining compliance with GxP and regulatory requirements.

Temperature Monitoring in Clinical Trials Supply Chain >

Real-World Success by Leading Pharma Companies

Some of the largest pharma companies have already embraced automation with remarkable results. Some sponsors have successfully onboarded hundreds of studies to automated temperature monitoring, significantly reducing clinical site workload and minimizing excursion risks. By streamlining the evaluation process, these organizations have been able to release investigational drugs more quickly, ensuring that critical treatments are readily available to patients.

With 94.9% of temperature excursions instantly resolved, we’ve seen a dramatic reduction in quarantine times, ensuring faster drug availability for patients.

In addition to improving efficiency, some of our customers have also implemented real-time storage monitoring across thousands of clinical sites. This has led to higher data accuracy, better visibility into trial performance, and a proactive approach to temperature management. By integrating real-time insights, sponsors can swiftly address potential risks, reducing the likelihood of temperature excursions impacting drug availability.

These results demonstrate the tangible benefits of automation in clinical trial supply chains. By eliminating manual processes and leveraging data-driven decision-making, sponsors are achieving substantial time and cost savings while ensuring compliance and patient safety.

Is Your Clinical Trial Future-Proof?

Sponsors who embrace automation can scale operations, minimize risks, and optimize compliance. Here’s a quick check-list to evaluate your current status:

  1. Do we have full visibility across the entire kit lifetime?
  2. Are our systems integrated for seamless performance?
  3. Are we leveraging real-time data for predictive forecasting?

If your organization still relies on manual processes, now is the time to take the next step toward automation.

At TSS, we support you in every stage of your digital transformation journey.

Are you ready to optimize your temperature monitoring processes?

"Automation is not just a competitive advantage, it’s a necessity for ensuring the safety, efficiency, and scalability of clinical trials."

Contact us >

You may also be interested in

What is Quality?

According to Lie Berglind, Chief Quality Officer at TSS, quality management is the soul of every organization. It is about doing what we say we should do, but also about measuring and determining how it was done, as well as documenting it to discover opportunities for improvement.
Read moreDownload Whitepaper

4 things to know about TSS new BLE data loggers

USB data loggers have been an important part of the life science temperature monitoring process for years. They have dramatically improved the safety of the drug distribution process by allowing the accurate measurement of temperature data at set points along the supply journey.
Read moreDownload Whitepaper

End-to-end visibility is the key to creating more efficient, cost-effective, and sustainable pharmaceutical supply chains

Pharmaceutical supply chains are often defined by a lack of connectivity between tiers, stakeholders and operational islands. It doesn’t have to be that way.
Read moreDownload Whitepaper

You may also be interested in

10 Steps to Navigating Sustainability in the Pharma Supply Chain

In the complex world of pharmaceuticals, sustainability is becoming a key part of business strategy. The push for a greener future is driven not only by government rules but also by the expectations of communities and customers. However, making the supply chain sustainable while balancing costs and maintaining high quality can be challenging. This requires careful planning and a commitment to long-term goals.
Read more

TSS Receives CDP SME Climate Score 'SME B' for Strong Climate Actions

TSS, a global company specializing in temperature monitoring for the pharmaceutical supply chain, is proud to announce that it has received an 'SME B' rating from the 2024 CDP SME Climate Score. This recognition highlights TSS’s commitment to being open about its environmental impact and taking steps to reduce it.
Read more

Subscribe to our newsletter

Sign up for our newsletter to receive all the latest TSS news and insights in temperature management solutions.