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Clinical Trials and Site Monitoring Made Easy

From packaging to patient, get superior temperature monitoring control and visibility to your entire clinical supply chain with ELPRO

Clinical Trials and Site Monitoring Made Easy

From packaging to patient, get superior temperature monitoring control and visibility to your entire clinical supply chain with ELPRO

Simplify Paperwork and Data Gathering
In Your Clinical Supply Chain

ELPRO LIBERO ITS electronic indicators in the clinical supply chain


There’s a lot on the line in clinical trials. Patient safety is a top concern, and confirming product quality helps to ensure trials stay on schedule. However, most clinical trial kits and products are sensitive to temperature, which can affect product quality. Each product or kit has a certain, limited stability budget, which is reduced by any deviation from the many transport and storage steps. There are two temperature monitoring approaches for clinical supply chains. You can dramatically simplify your monitoring and data gathering processes with a smart indicator.

 

 

Do This...

long-term indicator

Use a long-term indicator: Attach an electronic indicator at point of manufacture or filling and monitor the entire life of the product, to the patient. Read more how LIBERO ITS deducts temperature deviations continuously from the configured stability budget for the entire life of the product.

 

...Not This.

Measure and puzzle data

Measure and puzzle data: Measure each portion of the supply chain separately to account for any deviations, then puzzle together the Time Out of Refrigeration (TOR).

You've Got Options.

 

There are choices for monitoring solutions that may fit your supply chain depending on supply chain route (site to site, clinical site or Direct-to-Patient); value of the product and complexity of certain lanes. Then, when it reaches the clinical site, how can you be sure temperature is in specification while in refrigerator storage until patient administration? There are many times when monitoring on individual product level is valuable, even in storage.

1. Schedule Project Start-up/

Scoping Call

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2. Receive Proposal of

Services & Costs

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3. Schedule Date &

Resources Required

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Schedule Start-up Call

What's Your Application?

Choose the ELPRO solution below that best fits your clinical trial or site monitoring application anywhere along the entire supply chain.

 

Monitor Clinical Trials During Storage/Transport

LIBERO CL USB/PDF Logger

 

  • Type: USB/PDF data logger
  • Battery life: Multi-use 1 year
  • Parameters: Internal temperature sensor (-35 °C to +50 °C)
  • Transport monitoring: Generate PDF report at arrival at destination
  • Monitoring & alarming during storage: Quarterly download of data, alarm on display
More about LIBERO data loggers

Real-time Tracking During Transport or On Site

LIBERO GL

 

  • Type: Real-time data logger
  • Battery life: Multi-use 1 year
  • Parameters: Internal temperature sensor (-10 °C to +50 °C), Position, Light, Tilt
  • Transport monitoring: Real-time visibility, generate report at destination
  • Monitoring & alarming during storage: Automated monthly report, 24/7 alarming via email
More about LIBERO Gx

End-to-End Kit Level Monitoring

LIBERO ITS long-term electronic indicator 

  • Type: Electronic indicator
  • Battery life: 4 years
  • Parameters: Internal temperature sensor (-20 °C to +50 °C)
  • Transport monitoring: Press button to get OK for product release
  • Monitoring & alarming during storage: Press button to get OK, download if ALARM
See LIBERO ITS

Refrigerator or Freezer Monitoring

 

Once the product reaches the clinical site, there are many quality control protocols in place to ensure patient safety and smooth clinical trials. Clinical site staff need to know that the product has been kept in temperature specification while on site to ensure the clinical product being administered to the patient is safe and efficacious. A reliable temperature monitoring system provides that assurance. Whether the clinical products and kits are stored in refrigerators, freezers or across multiple small storage facilities, choosing the right temperature monitoring system can help ensure success. Stand-alone "independent" temperature monitoring systems are an easy-to-use approach that provide local audible/visual alarms on the device display.  LIBERO W for clinical sites requires no installation or IT infrastructure, measures -35 °C to +50 °C, and is always 100% GxP compliant. Networked, "connected" centralized monitoring systems on the other hand offer more automated processes. The ELPRO Cloud starter kit uses a real-time data logger to connect to the cloud via radio bridge. Software in the cloud sends alarm notifications globally, 24/7 by email and automated monthly reports. These systems are more suitable for growing sites, with remote system users.

 

Room with Freezers

Monitoring As a Service for CROs: Safe and Easy

 

Are you tired of customers and sites having no knowledge of temperature monitoring?

Is your organization responsible for products stored at many remote sites? Are you tired of running after data? You should strongly consider offering “monitoring as a service.”

A CRO can bring the value added benefit of competency, monitoring technology and quality control processes to clinical sites. With ELPRO's easy to use LIBERO family of data loggers, you can take ownership of monitoring valuable products at small storage locations or refrigerators.

 

Consider these advantages:

  • Installation is simple so remote sites can do it themselves

  • All data is collected centrally in one archive

  • In case of alarms, the remote sites are notified and see their exact sensor

  • The hardware is safe and easy to use; easy uploading to software

  • You have management overview and control of alarm criteria on all sensors, battery levels, access to calibration certificates, and admin rights for all users

Clinical Trials
Get a Quote

Whitepaper on Temperature Monitoring for Direct-to-Patient Logistics

A New Approach for Temperature Monitoring in a Changing Clinical Supply Chain Environment.

DOWNLOAD

Contact Us About Your Next Clinical Trial.

 

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SERVICES GxP Compliant Consulting & Support

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