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Ensuring study integrity and reliability during a drug recall

Technology and services delivered on schedule

A safety recall, by definition, is fraught with tension given the ultimate risks and the need to act swiftly with no margin for error. During a clinical trial in which only a portion of the product or a specific kit type is being recalled, the study need not be jeopardised. But it must be meticulously managed.

When a Sponsor was faced with such a situation, the company’s CRO suggested that Almac’s trusted professionals be called. Working in
concert, Almac Clinical Technologies (ACT) and Almac Clinical Services (ACS) kept the study going without unblinding, losing patients, or delaying the trial.

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