Editor's note: This post has been updated to reflect current industry trends, including the expanded use of biologics, cell and gene therapies, and direct-to-patient supply models, and to incorporate Signant's fully launched Temperature Excursion Management solution.
The pharmaceutical industry is developing more temperature-sensitive, high-value investigational products (IP) than ever before. Biologics, cell and gene therapies (CGTs), and antibody-drug conjugates (ADCs) demand meticulous cold chain oversight — a single undetected temperature deviation can compromise drug stability, jeopardize patient safety, and trigger costly resupply events.
At the same time, the continued expansion of decentralized and direct-to-patient (DtP) trial models has multiplied the number of handoff points in the clinical supply chain — each one a potential source of untracked temperature exposure. With IP now traveling from manufacturer to depot to last-mile carrier to patient home, the ability to track cumulative temperature excursions across the entire journey has become essential, not optional.
Regulatory expectations have risen in parallel. Both FDA and EMA/GDP guidance increasingly call for comprehensive documentation, complete audit trails, and data integrity across all stages of temperature monitoring — making GxP-compliant excursion management a compliance requirement, not just a best practice.
Despite these rising stakes, many sponsors and study teams are still managing temperature excursions with fragmented, manual, or siloed systems that weren't designed for today's trial complexity.
Signant's TEM — a module within the Signant SmartSignals® Supplies platform — was purpose-built to replace fragmented, manual excursion management with a unified, automated, end-to-end system.
End-to-end cumulative tracking. Signant TEM consolidates temperature data from transit, warehouse, and site storage into a single longitudinal record for each IP unit, giving sponsors a complete picture of cumulative exposure and remaining stability budget throughout the entire supply chain cycle.
Drug-specific excursion thresholds. Rather than applying a generic profile to an entire shipment, TEM supports medication-specific excursion thresholds based on individual stability profiles. This enables accurate, sophisticated monitoring within mixed shipments — particularly valuable for trials involving biologics, CGTs, or other high-sensitivity IP.
Real-time notifications and in-transit visibility. TEM supports both USB and Bluetooth-based temperature monitors, enabling excursion data to be accessed while IP is still in transit — not after delivery. Real-time status notifications allow teams to act before a compromised product reaches a site.
Integrated quarantine and adjudication workflow. When an excursion is identified, TEM triggers a structured quarantine and adjudication process. Authorized users can assess the excursion and, where appropriate, override material status — preventing unnecessary waste while maintaining full compliance documentation.
Seamless workflow integration. Temperature monitor inclusion is embedded directly in the pick-and-pack workflow, eliminating the need for separate manual steps. TEM integrates with Signant SmartSignals RTSM and third-party RTSM systems, and supports multiple monitors within a single shipment.
Full GxP audit trail. Every action from excursion detection through adjudication to disposition is documented in a complete, GxP-compliant audit trail, supporting regulatory submissions and inspection readiness.
The ability to track not just whether an excursion occurred, but the total cumulative temperature exposure of each IP unit across its entire lifecycle, is the key capability gap in legacy TEM systems. For high-value, temperature-sensitive therapies like biologics and CGTs — where the cost of a destroyed batch can be substantial and resupply timelines can be long — this end-to-end visibility directly protects both patient safety and study timelines.
Signant's TEM is integrated within the same platform sponsors use for clinical supply chain management, RTSM, and randomization — meaning there is no separate system to validate, train on, or reconcile.
What is temperature excursion management (TEM) in clinical trials? Temperature excursion management refers to the processes and systems used to detect, document, assess, and adjudicate instances when an investigational product (IP) is stored or transported outside its specified temperature range. Effective TEM tracks excursions cumulatively across all supply chain legs — from manufacturing through distribution to the clinical site or patient — to ensure that IP dispensed to patients remains within known stability conditions.
What is a stability budget, and why does it matter for TEM? A stability budget defines the total acceptable amount of time a drug product can spend outside its labeled storage conditions without risk to its safety, quality, or efficacy. As a product moves through the clinical supply chain, temperature deviations "consume" parts of that budget. Tracking the remaining stability budget (RSB) in real time — across all legs of the journey — is the purpose of end-to-end TEM. If the RSB is depleted, the product cannot be dispensed safely.
What are the biggest risks of inadequate temperature excursion monitoring in clinical trials? The primary risks include: dispensing compromised IP to patients (patient safety risk), delayed detection leading to wasted product that could have been adjudicated and released, regulatory non-compliance due to incomplete audit trails, and late-stage quarantines that delay patient dosing and disrupt study timelines.
How does Signant's TEM integrate with RTSM? Signant's TEM integrates directly with Signant SmartSignals RTSM, allowing excursion status and quarantine decisions to automatically reflect in supply allocation and dispensing workflows. Integration with third-party RTSM systems is also supported.
Which types of trials benefit most from automated TEM? Trials involving biologics, cell and gene therapies, ADCs, vaccines, or any other temperature-sensitive IP, particularly those using decentralized, hybrid, or direct-to-patient supply models, benefit most from automated, end-to-end TEM. The more complex the supply chain, the greater the risk exposure from manual, fragmented excursion management.
Signant's Temperature Excursion Management is available as a standalone module within the Signant SmartSignals® Supplies platform and can be combined with Signant's broader clinical supply chain management and RTSM solutions for full end-to-end trial supply visibility.
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