Label concept combines first-opening indication, blinding for clinical trials

By Melissa Fassbender

- Last updated on GMT

During clinical trials investigational products must be neutralized to guarantee valid and compliant results. (Image: Schreiner MediPharm)
During clinical trials investigational products must be neutralized to guarantee valid and compliant results. (Image: Schreiner MediPharm)

Related tags Clinical trial Clinicaltrials.gov

Schreiner MediPharm’s new Flexi-Cap for Clinical Trial Supplies provides anti-counterfeit protection with blinding for transparent containers.

Gene Dul, president of Schreiner MediPharm US told us the product development goal is always to find the ideal solution​ for the actual customer application.

(Image: Schreiner MediPharm)
(Image: Schreiner MediPharm)

In this case, due to the sensitive topic of clinical trials and the need for a reliable blinding solution, it was necessary to find a suitable way to cover the complete container, while ensuring that the upper cap can be opened easily by means of tear strip and at the same time ensuring that the blinding functionality will not be impaired​,” he said.

Additionally, Dul explained the label and cap construction needs to be flexibly adapted to the glass container shape and size, and stick reliably.

During clinical trials, it is absolutely necessary to neutralize investigational products to ensure that active drug and placebo cannot be distinguished from one another, in order to guarantee valid and compliant results​,” he added.

Transparent containers present a particular challenge as each investigational product has to have the same appearance.

To address this issue, the new Flexi-Cap solution covers the whole container and features two opaque printed film caps that are combined with a marking label. The label also features a booklet with space for text in several languages. An integrated tear strip in the upper cap also offers an irreversible first-opening indication.

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