Reliable Vial Blinding from Schreiner MediPharm for International Clinical Trial

Die Vial-Verblindungslösung von Schreiner MediPharm für WuXi STA ermöglicht eine zuverlässige Neutralisierung von Verum und Placebo in der klinischen Studie. © Schreiner MediPharm / The vial blinding solution from Schreiner MediPharm for WuXi STA enables reliable neutralization of verum and placebo in a clinical trial. © Schreiner MediPharm

Schreiner MediPharm has developed a reliable blinding solution for vials used for clinical dosing. The self-adhesive film labels are colored as well as semi-transparent. As a result, the different liquids of the investigational drug and placebo cannot be distinguished from each other while the fill level of the vials can still be seen.

In clinical trials, it is important to reliably blind the investigational products so that trial participants cannot distinguish verum and placebo from each other. That is a prerequisite for obtaining valid results regarding the efficacy of the tested medicine. In the case of transparent containers such as vials, that poses special challenges to a blinding solution because the color of the vial content must be neutralized and at the same time remain visible.

Schreiner MediPharm has developed a colored film label for vials that are filled with a liquid active ingredient (API). The specialty blinding solution consists of a self-adhesive label with semi-transparent yellow coloration. Consequently, different liquids filled into vials can no longer be distinguished from each other. At the same time, however, the label is transparent enough for identifying the fill level of the liquid inside the vial. The solution from Schreiner MediPharm thus ensures efficient and flexible blinding of the investigational products and helps optimize processes during a clinical trial.

Schreiner MediPharm designed the blinding label with WuXi STA, a global Contract Research, Development, and Manufacturing Organization (CRDMO). Among other things, the company offers clinical supply services for clinical trials and has been manufacturing clinical investigational products since 2008. The blinding solution from Schreiner MediPharm and WuXi STA was developed precisely for the vials —and complies with the requirements of international regulations for clinical trials.