The module
Automated product release on item-level, based on end-to-end temperature exposure.
Excursion management from shipment to dispense in serialized clinical trials

TSS Clinical Module

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.  

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.

Excursion Management: turning days into seconds at clinical sites worldwide

  • Download TSS Clinical Module product sheet here

Current IRT Integrations:

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

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

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.

  • Watch on-demand here
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