Clinical

Module

The module
The TSS Clinical Module is a cloud-based software module designed specifically for managing temperature-sensitive products in clinical trials. It automates the entire process of temperature monitoring, data logging, and decision-making related to temperature excursions, ensuring that clinical trial products remain within their specified temperature ranges from the supply chain to the patient. 
Automated product release on item-level, based on end-to-end temperature exposure. Excursion management from shipment to dispense in serialized clinical trials.
Enhanced Efficiency and Automation
Drastically reduces the time and effort spent on temperature monitoring by automating what are traditionally manual processes. This enables faster decision-making, cutting response times from days to seconds.
Cost Reduction
By automatically evaluating temperature excursions and determining product viability in real time, the module reduces unnecessary product waste and the need for resupplies. This leads to significant cost savings, particularly for expensive clinical trial products.
Improved Compliance and Audit Readiness
The system ensures full compliance with GxP regulations and provides detailed, real-time documentation for all temperature-related activities. This simplifies the audit process and minimizes regulatory risks.
Patient Safety
Ensuring that temperature-sensitive products are stored and used within the correct parameters directly protects patient safety. The module provides rapid assessment of product usability, reducing the risk of compromised product use in clinical trials.
Scalability and Flexibility
The TSS Clinical Module is logger-agnostic and works with existing systems and hardware. This makes it a scalable solution that can grow alongside an organization’s needs without requiring a complete overhaul of their current infrastructure.
Seamless Integration
The module integrates smoothly with SSO, IRT/RTSM, and CTMS systems, allowing for an uninterrupted flow of data across the entire clinical trial process. This leads to improved site efficiency and a more streamlined experience for all users.

Excursion Management

Most excursions happen at clinical sites. Often primary and secondary distribution, and storage monitoring is done in silos which results in inefficient use of stability data. When an excursion happens at the clinical site, manual scrambling to understand the full temperature exposure of affected units takes time. The products are quarantined in IRT by several manual steps involving several stakeholders.  

Turning Days Into Seconds At Clinical Sites Worldwide

TSS Clinical Module is an end-to-end solution, designed for the clinical trial supply chain. It aggregates data from pre-shipment, shipment, and storage on kit or unit level and compares the cumulated temperature exposure to stability data through an integration with the IRT/RTSM. This way drugs can automatically be either released, or put in quarantine in the IRT for further investigation. It is a cloud-based application that is technology agnostic, supporting a wide range of industry in-transit and storage loggers as well as IRT integrations.

IRT Integrations

Integrations are independent of choice of logger, whether TSS or 3rd party. Additional integrations can easily be made upon customer request.

TSS has also developed a standardized integration process that can be applied to most IRTs, accelerating the process with minimal input from the sponsor.

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Excursion Management for Clinical Supply

In collaboration with endpoint Clinical, we discuss current industry trends and the main challenges and opportunities that a unified approach incorporating IRT and end-to-end temperature solutions bring to sponsors.

30+
Years of experience
20 000+
users worldwide

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