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.