Sanofi helps develop blinding label for clinical trials

Compliance in clinical trials requires that the active drug and placebo cannot be distinguished, which presents a unique challenge for labeling. 

In order to address this challenge, Schreiner MediPharm, a Germany-based pharmaceutical labeling solutions provider has created a new label for blinding syringes during trials. The new label was developed in part with Sanofi’s clinical trials supply unit.

In clinical trials it is crucial to equip the investigational products with all required information in different languages,” Barbara Decker, project manager at Schreiner MediPharms’ Clinical Trial Services, told us – usually this is done with the help of booklet labels.

However, in case of syringes, automatic dispensing of booklet labels means a real challenge and might cause problems with some processing machines,” explained Decker.

According to MediPharm, the new label neutralizes investigational products – preventing researchers’ ability to distinguish an active drug from the placebo. Specifically, the label ensures investigational products appear the same, even in transparent syringe barrels, and is available is one- or two-layer wrap designs.

According to the company, the new labels will increase safety in clinical trial execution as one single label can be used globally for each product while also providing a blind.