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Do you agree that the trend within clinical trials is moving towards using controlled ambient containers for regular room temperature shipments?

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Q: Do you agree that the trend within clinical trials is moving towards using controlled ambient containers for regular room temperature shipments? I have even heard of some going so far as to include a temperature logger inside. Can you comment?

—name withheld by request

 
A: Your assessment of the current situation is correct. Most companies are aware that controlled ambient shipments are likely to be mandated by regulators in the medium term. There are some countries such as Canada where most companies are interpreting the guidelines as requiring controlled / measured ambient shipments already.

In addition, some companies with the majority of patients in countries with extreme temperatures have chosen to mandate controlled ambient shipments. We expect this trend to continue.

—Christine Milligan, Ph.D., director of Global Logistics, Fisher Clinical Services

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