Clinical Trial Shipment Monitoring
Shipment Monitoring
Per-shipment monitoring for clinical trial materials with sensors placed inside primary containers. Includes lane qualification, excursion management, IVRS/IXRS integration, and full GDP/GxP-compliant chain-of-custody documentation for every shipment.
Per-Shipment Trial Material Integrity
Clinical trial materials — investigational medicinal products, biologics, and comparators — are irreplaceable once dispensed to a site, and a single undocumented excursion can invalidate a patient cohort or delay a regulatory submission. This offering gives sponsors and CROs an auditable, per-shipment temperature record that satisfies both GDP and GxP requirements at every custody handoff.
How it's deployed
Compact single-use or reusable data loggers are placed directly inside primary shipping containers before dispatch, capturing continuous temperature readings at configurable intervals as short as one minute. Lane qualification data is used to pre-validate route performance, and IVRS/IXRS integration means excursion events are automatically flagged in the trial management system without manual intervention.
Evidence & Reporting
Each shipment closes with a GDP/GxP-compliant chain-of-custody report including time-stamped sensor readings, excursion summaries with MKT calculations, and a complete custody log signed under FDA 21 CFR Part 11 electronic signature requirements. Excursion management workflows produce documented impact assessments that can be attached directly to the Trial Master File.
Included and Optional Capabilities
Included
- Real-time Temperature Sensors
TS sensors for continuous monitoring
- Full Shipment Excursion Reports
Complete excursion documentation
Optional add-ons
- Auto Departure/Arrival Detection
Automatic shipment event detection
- ERP/LIMS Integration
System integration
Related Shipment Monitoring Offerings
Frequently Asked Questions
When the sensor detects a temperature breach, an automated alert is sent to the connected IVRS/IXRS system, which can immediately flag the affected shipment or patient kit in the trial database. The sponsor or CRO QA team receives the excursion notification in real time and can initiate an impact assessment before the package even arrives at the investigator site.
Yes — sensors are configurable per-shipment with independent alarm thresholds, so ambient room-temperature products and refrigerated biologics in the same trial can each be monitored against their own specified storage conditions. Lane qualification data is maintained separately per condition range, keeping regulatory documentation clean for each product type.
The platform generates a formal excursion report that includes the full time-temperature profile, breach duration, maximum deviation, and a MKT (Mean Kinetic Temperature) calculation. This report can be referenced in the destruction record or return-to-depot paperwork, satisfying GDP requirements for documented deviation handling.
Plan Clinical Trial Shipment Monitoring
Talk with Seemoto about the sensor, gateway, reporting, and compliance setup for clinical trial shipment monitoring.