Specialty Label for Needle Protection System in International Phase III Trial.
Blauvelt, N.Y. – Schreiner MediPharm, a Germany-based global provider of innovative functional label solutions for the pharmaceutical industry, has developed a compact Booklet-Label for a needle protection system used in an international phase III clinical trial conducted by pharmaceutical corporation Sanofi. Comprising over 30 pages, the extensive yet compact booklet contains all required product information in more than 20 languages.
Accuracy, safety, efficiency and speed are essential to the successful performance of clinical trials. Since most studies are conducted internationally, the investigational drugs must be reliably marked and provided with a complete set of information in several languages. For this purpose, Sanofi required a multi-page label making the product information available in many different languages. In addition, the label needed to firmly adhere to the plastic needle protection system without impairing the system’s functionality.
The Booklet-Label developed by Schreiner MediPharm is tightly wrapped around the needle protection system. The compact booklet encompasses 32 pages with medicinal information in 22 languages. It reliably adheres to the plastic substrate of the needle protection system and, due to its flexible material construction of thin booklet paper plus film layers, can be easily wrapped around the quadrangular device. A starter tab makes it possible to easily open and re-close the label.
The Booklet-Label is partially affixed to the device so that the pre-filled syringe and its contents are readily visible after opening. The booklet is equipped with a perforation, allowing for its removal before injection—only a small part of the label which, for instance, may contain variable data, subsequently remains on the device. The label material is suitable for custom overprinting using TTR printers, thus efficiently and flexibly supporting the processes during the clinical trial.
Schreiner MediPharm’s Clinical Trial Supplies (CTS) team is a competence and service partner for clinical trials. The team has comprehensive expertise in the area of Clinical Trial Supplies and provides individual and flexible consulting support to all customers according to their needs. A process center specializing in Booklet-Labels is dedicated to creating reliable solutions that are optimally adapted to the packaging of investigational drugs.
Schreiner MediPharm’s Booklet-Label for the needle protection system used by Sanofi in a clinical trial encompasses 32 pages.