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How to Overcome Complex Cold Chain Clinical Trial Challenges

Royce Heap

By: Royce Heap March 22 2018

Tags: Cold Chain, Logistics for Clinical Trials

Cold Chain Supply Chain Challenges

The industry’s evolution to handle increased quantities of complex cold chain biologics across many continents presents challenges to all parties across the supply chain. In fact, the globalization of clinical trials, with an increased focus on far-to-reach patient pools in Asia Pacific and Latin America, has expanded the footprint of the traditional supply chain. Proficient monitoring and tracking of cold chain supplies from point of origin to site can help ensure the integrity and security of clinical supplies as they make their journey across continents. Accurate temperature history data is imperative to effective vaccine management as storage outside of temperature specifications can render a vaccine ineffective.

What is a data logger?

A data logger/temperature monitor is an electronic monitoring device that continuously records temperature while in transit. Data loggers let you track and collect valuable data about your temperature-sensitive clinical supplies shipments. In general, most temperature monitors are designed for relatively short duration shipments (10-90 days). Data from individual sensors is usually transmitted by wire or by radio signal to a base station or to a personal computer. In some instances audible alarms will sound to highlight temperature excursions across the supply chain. That way the Sponsor can make immediate accept or reject decisions on stability data ensuring product integrity. Over time all parties gain greater visibility into every critical step of the cold chain supply chain for their products.

Alarm types:

It is important to appreciate the reasons as to why an alarm may sound. For example, it could be a once-off event, related to time, whereby the alarm will sound if the temperature is out of range for the time specified. Or is it related to cumulative time out of temperature specifications? In this instance the alarm sounds due to cumulative consecutive or non-consecutive temperature out of environment for the time specified. Ensure that key personnel know and understand all alarm types so that the correct action can be taken in response to each alarm.

The importance of training:

A cold chain supply chain is only robust if all parties to the supply chain appreciate the importance of maintaining product integrity at all times. Consider the journey vaccines take from point of origin to site delivery. Education is key. Top tips include:

  • Train all personnel on the importance of maintaining stringent storage conditions for all vaccines
  • Educate team members on precise location of temperature monitors in shipment boxes, fridges and freezers. Temperature monitor placement matters as the wrong location can result in temperature spikes that could jeopardize the integrity of the product
  • Encourage personnel to take pro-active action when an alarm occurs
  • Clearly document what action should be taken should a deviation occur. Define the measures that should be taken to ensure that deviations of this nature do not happen again.
  • Define who makes a decision on the product integrity? Is the local health authority, the Sponsor, the Qualified Person on site, the logistics provider?
  • For fixed controlled storage units, set up generator back-up to handle significant power outages, particularly if regional power outages are common

Probably the best piece of advice is to educate personnel on when to switch on & switch off the temperature monitor. If the monitor is not switched on just before a shipment is sent, then the Investigative Medicinal Product (IMP) will not be monitored during transit. In addition, if the product is used on arrival at the investigator site, but the temperature monitor is not stopped manually, it will continue to record irrelevant data. In both instances good training and oversight of logistics personnel will instill a sense of ownership, one that is imperative if we are to maintain integrity of clinical supplies and overcome cold chain supply chain challenges.

Learn more about key cold chain trends, the importance of a robust supply chain, and planning recommendations for biopharmaceutical companies preparing to scale up to global vaccine trials.

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Royce Heap