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Manufacturer and global supplier
of temperature data-collecting
devices used for documenting
environmentally-sensitive
products throughout the cold
chain. ISO 9001:2008 certified.

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Cold Chain Solutions

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•News

August 2013

New FDA Guidance Calls for Increased Emphasis on Centralized Trial Monitoring

A new guidance document released by the US Food and Drug Administration on 6 August 2013 calls on sponsors to develop centralized risk-based monitoring strategies for clinical trials involving medical products with the ultimate goal of enhancing protections for human subjects while simultaneously improving the quality of clinical trial data

In the guidance, Oversight of Clinical Investigations, A Risk-Based Approach to Monitoring, FDA "encourages greater use" of centralized monitoring practices compared to historical trends that emphasized on-site monitoring as it applies to pharmaceutical, biologics, medical devices and combination products.

“Centralized monitoring is a remote evaluation carried out by sponsor personnel or representatives (e.g., clinical monitors, data management personnel, or statisticians) at a location other than the sites at which the clinical investigation is being conducted. Centralized monitoring processes can provide many of the capabilities of on-site monitoring as well as additional capabilities.”

FDA's guidance lists several it says would "reflect a modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively," such as the use of centralized monitoring.

  • Supplement or reduce the frequency and extent of on-site monitoring
  • Target on-site monitoring by identifying higher risk clinical sites
  • Communication with Study Site Staff
  • Review of Site’s Processes, Procedures, and Records
  • Source Data Verification and Corroboration

DOCUMENTING MONITORING ACTIVITIES
Documentation of monitoring activities generally includes the following:

  • The date of the activity and the individual(s) conducting and participating in it
  • A summary of the data or activities reviewed
  • A description of any noncompliance, potential noncompliance, data irregularities, or other deficiencies identified
  • A description of any actions taken, to be taken, or recommended, including the person responsible for completing actions and the anticipated date of completion

Documentation of monitoring should include sufficient detail to allow verification that the monitoring plan was followed.

Marathon Product, Inc. provides wireless and networked products for centralized monitoring compliance.

December 2012

NIH Virus Research Center orders Marathon EDL-CO2 and microDL-200C electronic data loggers for biological studies.

Moses Lake Industries orders additional EDL-Net products for remote temperature monitoring.

Marathon introduces the EDL-RTD2 and EDL-LN2, 2-channel high temperature and -200C data loggers with large LCD screens for easy viewing and with built-in piezoelectric buzzers.

NADRO – Mexico
Marathon completes installation of 100 EDL-M5 wireless data loggers for 18 remote sites for monitoring warehouse operations of vaccines, medicines for Mexico's largest distributor of clinical supplies.

November 2012

Nu Skin orders Marathon EDL-Net data loggers for remote monitoring of raw materials and finished products for beauty applications.

University of Maryland School of Medicine orders Marathon microDL portable LCD loggers and EDL-WiFi data loggers for monitoring laboratory refrigerators and freezers.

September 2012

Marathon introduces 2c\temp-RH with 32 K memory USB data loggers for temperature and humidity data logging applications.

August 2012

Moses Lake Industries orders Marathon EDL-Net remote data loggers for raw materials and finished product monitoring.

US Pharmacopeial Convention orders Marathon microDL data loggers for monitoring drug and sample storage applications.

March 2012

John Hopkins University School of Medicine orders Marathon microDL-200C data loggers for shipment and storage applications.

University of Colorado orders Marathon microDL-200C loggers for monitoring blood and biological shipments.

February 2012

Marathon introduces Marathon Logger Pulse, an Enterprise Software Package for managing the cold chain. Now see all your remote sites in real time with instant alarm notifications via cell phone and or email to multiple addresses. 21 CFR compliant with an unlimited number of users and simultaneous access to data in real time utilizing Marathon's precision data capture technology.

   rev. Nov-12-2014