Syringe-Blinding for Clinical Trial from Sanofi


Syringe-Blinding for Clinical Trial from Sanofi

It is important to reliably ensure that active drug and placebo cannot be distinguished from one another during blinded clinical trials for investigational products. At the same time, there is a legal obligation to provide extensive product information in different languages for the drug being tested. This presents a particular challenge for labeling, especially when transparent containers with small radii are involved. Schreiner MediPharm has developed a special solution for syringes together with the Clinical Trial Supplies Unit of Sanofi, one of the leading global healthcare companies.

For use in clinical trials, the label must provide sufficient space for comprehensive text. In addition, it must ensure that each investigational product has the same appearance, even in transparent syringe barrels. Depending on the required amount of text, a one- or two-layered wrap design is used, each of which allows double sided printing per layer of film. Extensive, high opacity printing of the transparent material is required to do this.

The product solutions are based on a particularly long, one-layered wrap-around label (Pharma-Wrap) and a two-layered label (Euro-Label). Very flexible film material is required, so that the label can be easily wrapped around the syringe with a small radius. The part of the label that is directly glued to the syringe consists of a tinted transparent foil. This enables reliable neutralization of the syringe without obstructing the view of the contents. The remaining part of the label is printed on a white background, so that information can be provided on both sides. The integrated peel-open tab enables easy opening and closing of the label.

These specialty labels increase flexibility, efficiency, and safety for the execution of clinical trials, because one single label variant can be used globally for labeling the respective product.