Temperature Monitoring in Clinical Trials – Interview with Rob Adriaansen

LOUNGES

In this elproINTERVIEW, ELPRO’s Senior Account Manager Rob Adriaansen talks about characteristics and challenges of temperature monitoring in clinical trials.

Temperature monitoring is a critical aspect of clinical trials, especially for the handling and storage of sensitive biological samples and investigational products. Can you describe key characteristics of clinical trials and discuss some of the challenges associated?

Being a solution provider for intelligent stability budget monitoring of pharmaceutical products, ELPRO is fully aware of the uniqueness of a clinical trial setting, for example its many stakeholders. Pharma companies, sponsors, CRO, CMO, investigators, participants, logistics service providers and of course authorities – each of these stakeholders may be involved at different stages of the supply chain, making coordination and communication crucial.

Clinical trials involve a highly complex supply chain, characterized by a decentralized network of sending sites, a variety of transport modes, diverse receiving locations, numerous border crossings, and challenging local conditions, especially during last-mile delivery. At every stage of this process, it is essential to ensure that all requirements – such as temperature control, regulatory compliance, and timely delivery – are met to the highest standards.

For the required temperature monitoring solutions, one clear challenge is developing software and hardware that is highly user-friendly. Local staff at clinical trial sites will be using the monitoring devices, and they neither have the time nor the capacity to deal with complicated systems. Devices and software must be intuitive, reliable, and easy to use, providing just the right amount of information they need at that moment to ensure smooth and uninterrupted operations.

This simplicity also applies to the alarm system. On the monitoring device, alerts must be clear and easy to interpret, allowing users to quickly determine whether conditions are acceptable or not. It should be immediately obvious when action is required—whether it's releasing the product, sending it to quarantine, or taking another appropriate step—without any ambiguity.

Another key factor is compliance. Strict regulations must be followed at every clinical site and throughout the entire clinical trial supply chain. These requirements need to be clearly understood and consistently adhered to. This is where data plays a crucial role, ensuring that all processes are properly documented and compliant with regulatory standards.

Speaking of data management: What role do data collection, analysis, and archiving play in clinical trials?

Data management plays a pivotal role in maintaining GDP compliance throughout the clinical trial supply chain. The data must be accurate and reliable, as it forms the basis for critical decisions – such as whether a volunteer or patient will receive the medication being shipped. Any errors or inconsistencies in the data could directly impact patient safety and the trial's success.

Data management in clinical trials raises several critical questions:

• Who owns the data?

• Who is responsible for data collection?

• Who is accountable for assessing clinical trial data?

• Who manages the archiving of that data?

• How and where can all data—including data from third-party systems—be centralized?

• Who has access to this centralized data?

• How can data be integrated with IRT systems?

ELPRO provides the hardware, software, and solutions needed to address all these questions, ensuring a seamless and efficient process from start to finish.

How does data management contribute to ensuring compliance, and what other key elements of compliance should be taken into consideration?

Full traceability of temperature-controlled shipments is critical for GDP and GCP compliance in clinical trials. Cold chain data management solutions help pharmaceutical companies achieve end-to-end compliance and provide maximum visibility across their supply chains.

Temperature monitoring systems need to be qualified and validated to meet global standards to integrate seamlessly into clinical trial workflows. These solutions also help generate compliant reports, ensuring all trial and distribution data is available for regulatory review when needed.

In clinical trials and pharmaceutical logistics, precision is paramount. ELPRO’s GxP services, including container and fleet qualification and GxP-compliant temperature mapping, contribute significantly to protect the integrity of temperature-sensitive products. 

How does ELPRO approach the development and implementation of effective temperature monitoring solutions tailored specifically for clinical trials?

ELPRO offers a range of devices for effective cold chain monitoring, operating at both the box and kit levels. Our solutions include comprehensive PDF data loggers as well as Bluetooth® Low Energy (BLE) solutions for enhanced connectivity. For real-time monitoring, we provide the IoT Real-Time data loggers LIBERO Gx for transport monitoring and the ECOLOG-PRO xG, an advanced device designed for tracking temperatures in refrigerators and freezers.

In the context of Direct-to-Patient solutions and last-mile monitoring, the LIBERO ITS stands out as a handy, user-friendly device. Its thin design allows for easy installation and attachment to the package. This indicator reliably shows whether the monitored kit or package has remained within the designated temperature range throughout the entire monitoring period.

With numerous possibilities available, ELPRO can design and implement a highly reliable and compliant temperature monitoring system tailored to address specific clinical trials monitoring needs.