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Drug Transportation and Storage Monitoring Solutions for Clinical Trials
From package to patient, use ELPRO to achieve superior temperature monitoring control and visualization throughout the clinical supply chain.
Streamlining Document Management and Data Capture in the Clinical Supply Chain
There are many issues in clinical trials. Patient safety is a primary concern, and confirming product quality helps ensure that the trial runs as planned. However, most clinical trial kits and products are temperature sensitive, which can affect product quality. The stability of drugs and biological samples depends in part on the range of temperatures to which they are exposed during storage and transportation. Each product or kit has a certain, limited stability budget, which can be reduced by deviations in many transportation and storage steps. To avoid this, temperature monitoring during clinical trials is critical.
Clinical trial drugs are usually transported by various methods, such as refrigerated or frozen transportation, rapid freezing/thawing or special packaging, etc., to ensure the safety and efficacy of the drugs during transportation. During transportation, temperature monitoring is a critical task and there are usually two methods of temperature monitoring.
Smart Indicator, Temperature Indicator（The simple design and operation of the product (e.g., temperature stickers, labels, or built-in sensors) allows for real-time monitoring of temperature changes during sample transport, and helps to greatly simplify the monitoring and data collection process.
Long-term indicator:Electronic indicators are installed during production or filling to monitor patients throughout the product's life cycle. HONGKE LIBERO ITS realizes a continuous reduction of temperature deviations from the configured stability budget over the entire life cycle of the product. This may last up to 1 year or even 3 years in the long term.
Refrigerator or freezer monitoring
Once a product arrives at the clinical trial site, there are many quality control processes to ensure patient safety and the smooth running of the clinical trial. Clinical field personnel need to know that product temperatures are in compliance while in the field to ensure that the clinical product is safe and effective for the patient. Reliable temperature monitoring systems provide this assurance. Whether clinical products and kits are stored in refrigerators, freezers or multiple small storage facilities, choosing the right temperature monitoring system helps ensure success.
A stand-alone temperature monitoring system is a suitable method for monitoring refrigerators or freezers. The monitoring system provides local audible and visual alarms on the equipment display.
Used in clinical sites, the Avision LIBERO W requires no installation or IT infrastructure, measures at temperatures from -35°C to +50°C and is always 100% compliant with the GxP standard. On the other hand, the networked centralized monitoring system provides a more automated process.
The elproCLOUD Starter Kit utilizes real-time data loggers connected to the cloud via a wireless network. The cloud software sends alert notifications around the globe via e-mail and automatic monthly reports around the clock. These systems are more suitable for remote system users with extended point requirements.
Are you tired of your customers and the field not knowing anything about temperature monitoring? Is your organization responsible for managing products stored at multiple remote monitoring points? Are you tired of chasing data? You should consider offering “Monitoring as a Service”!”
CROs can bring value-added benefits to clinical organizations in terms of expertise, monitoring technology and quality control processes. With the easy-to-use LIBERO series of data loggers from Avision ELPRO, you can autonomously monitor critical products in small storage locations or refrigerators.
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- Simple installation, remote monitoring points can be installed by yourself.
- All data collected in one centralized system
- If an alarm occurs, the remote monitoring point is notified and its exact sensors are viewed.
- Hardware is secure and easy to use; easy upload to software
- You can manage and control all sensor alarm criteria, battery level, access to calibration certificates, and administrative privileges for all users.
HONGKE complies with the Pharmaceutical Industry Code.
Clinical Trial Drug Transportation and Storage Monitoring Solutions
Depending on the supply chain route (point-to-point, clinical trial site, or direct-to-patient); how do you ensure temperature compliance when the product arrives at the clinical site, from refrigerated storage until patient administration? Depending on the value of the product and the complexity of the use case, HONGKE offers a wide range of monitoring solutions to fit your supply chain.
Depending on your application scenario, choose from the following HONGKE ELPRO solutions for clinical trials or field monitoring applications at any point in the entire supply chain.
HK-LIBERO CL USB/PDF
Temperature Recorder
Monitoring clinical trials during storage/transportation
- Type：USB/PDF Temperature Recorder
- Battery life: 14 months or 2 years for multiple uses
- Parameter: Internal temperature sensor (-35°C to +50°C)
- Transportation Monitoring: Generate PDF reports upon arrival at destination
- Monitoring and alerts during storage: download data quarterly and display alerts
HK-LIBERO GL
Real-time Data Logger
Transportation or on-site real-time tracking
- Type：Real Time Data Recorder
- Battery life: 1 year for multiple uses
- Parameters: internal temperature sensor (-10°C to +50°C), position, light, tilt angle
- Transportation monitoring: real-time monitoring, generating reports at the destination
- Monitoring and alerts during storage: automatic monthly reports, 24/7 alerts via email
HK-LIBERO ITS
Long-term Electronic Temperature Indicator
End-to-end suite level monitoring
- Type：Electronic Temperature Indicator
- Battery life: 4 years
Parameter: Internal temperature sensor (-20°C to +50°C) - Transportation Monitoring: Scanning QR code for reports
- Monitoring and alarms during storage: press the button to confirm, if the alarm downloads
Completion of aviation safety certification for safe air transportation
All of the above temperature recorders/indicators supplied by Hongke for vaccine transportation are powered by button cell batteries, compliant with IATA regulations, and are certified as safe for air transportation by the Shanghai Institute of Chemical Technology's Certificate of Cargo Transportation Conditions and Beijing DGM Air Transportation Hazard Identification Report Dieter Ziehm.
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The professional Hongke team will be the first to respond and provide you with the best service to solve all your problems.
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