Schreiner MediPharm has developed a compact Booklet-Label for a needle protection system used in an international phase III clinical trial conducted by pharmaceutical corporation Sanofi. On more than 30 pages, the extensive yet small booklet contains all the 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 was 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 content are readily visible after it has been opened. The booklet is equipped with a perforation, allowing for its removal before an injection—only a small part of the label, which may contain variable data for instance, will subsequently remain on the device. The label material is suitable for custom overprinting using TTR printers and thus efficiently and flexibly supports the processes during the clinical trial.
Schreiner MediPharm’s Clinical Trial Supplies (CTS) team is the competence and service partner for clinical trials. It 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.
About Sanofi Sanofi is a global healthcare company with headquarters in Paris and more than 100,000 employees. The company is represented in more than 100 countries, with global sales of about 34.5 billion euros in 2018. More than 15,000 Sanofi employees on three continents are engaged in research and development of new medicines and vaccines.
Publication free of charge if named © Schreiner MediPharm
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Schreiner MediPharm, a business unit of Schreiner Group GmbH & Co. KG based in Oberschleissheim near Munich, is a leading developer and manufacturer of innovative, multifunctional specialty labels and marking solutions with value-added benefits for the healthcare industry. Thanks to its strong solutions expertise and specialized know-how Schreiner MediPharm is a highly capable development partner and reliable quality supplier to leading pharmaceutical and medical device technology companies worldwide.
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