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Sanofi, Schreiner MediPharm develop clinical trial labels for blinding syringes

Regulations, different language requirements and labeling challenges with transparent containers among issues involved in this cooperative effort.

Regulations, different language requirements and labeling challenges with transparent containers among issues involved in this cooperative effort.
Regulations, different language requirements and labeling challenges with transparent containers among issues involved in this cooperative effort.

The Clinical Trial Supplies Unit of Sanofi in Montpellier, France, and Schreiner MediPharm developed a solution for blinding syringes during Sanofi clinical study trials.

To best guarantee valid and compliant results during clinical trials, it is important to neutralize investigational products to ensure that active drug and placebo cannot be distinguished from one another.

At the same time, there is a legal obligation to provide extensive product information in different languages for drugs being tested. That presents a challenge for labeling, especially when transparent containers with small radii are involved.

For use in clinical trials, the label must provide sufficient space for compulsory text. In addition, it must ensure that each investigational product has the same appearance, even in transparent syringe barrels.

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