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How Contract Research Organizations Optimize Cold Chain Operations During Clinical Trials
In the United States, 165,000 clinical trials each year are carefully designed and conducted to test the safety and efficacy of drugs before they are approved by the FDA. Because many medications, in particular vaccines, must be stored and transported in refrigerators and freezers, an intricate and complex cold chain is required to ensure they are continuously maintained within their proper temperature ranges.
Pharmaceutical and biotechnology companies frequently hire Contract Research Organizations (CROs) to manage clinical trials through all their stages. Rising pressure on these companies to be first to market can fast-track research to control costs, which also potentially adds greater risk to the integrity of experimental samples throughout the research lifecycle.
To mitigate risks by controlling the clinical trial’s cold chain operations, CROs must monitor environmental conditions, execute corrective actions when excursions in temperature occur, and analyze in-depth data gathered at each link in the chain to optimize efficiency, safety, and compliance. Among its many responsibilities, the CRO is charged with preventing the loss of clinical samples, which not only destroys years of investments, but also delays life-saving treatments for patients.
In this post, we take a look at how CROs use IoT-enabled Sensing-as-a-Service solutions to ensure regulatory compliance and optimize cold chain operations at each point of a clinical sample’s physical journey during its clinical trial.
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