Signant Launches Clinical IP Temperature Monitoring Module
PHILADELPHIA, PA – September 21, 2022 – Signant Health, the leader in evidence generation for modern clinical trials, today announced the launch of its comprehensive, cloud-based Temperature Excursion Management (TEM) solution, a standalone module within the company’s clinical supply chain management solution portfolio. The automated platform enables end-to-end monitoring of investigational product temperature excursion from manufacturing through distribution to clinical research sites.
Supporting the quality and safety of investigational products requires meticulous supervision of the environmental conditions to which they are exposed during storage and handling. Signant’s TEM solution enables sponsors to gather, consolidate, review, analyze, and take actions based on the temperature monitoring data collected at each step of the manufacturing and distribution process, thus eliminating manual, error-prone evaluation processes that can take hours or days. Flexible integration options and automation help sponsors and research sites track temperature excursions for all clinical trials from a single user interface while generating a full genealogy and an enhanced audit trail for each product unit.
“The addition of the Temperature Excursion Management solution into our supplies inventory management platform enables customers to track cumulative temperature excursions against a library of electronic stability profiles,” said Oliver Cunningham, Signant’s vice president of supplies management solutions. He added, “They can also verify that temperature monitoring devices are launched and packed within the same workflow they use to pick and pack their patient supplies. By simplifying and accelerating these processes for customers, we enable end-to-end visibility into clinical IP temperature excursion history while supporting patient safety and full GxP compliance.”
The Temperature Excursion Management solution integrates with the latest version of Signant’s Planning, Materials, and Distribution (PMD) solution. Full integration with Signant SmartSignals RTSM solution is planned for 2023.
About Signant Health
Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 400 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, eConsent, RTSM, supply chain management, and data quality analytics. Learn more at www.signanthealth.com.
Contact:
Heather Bilinski
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