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.
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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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WuXi STA (stapharma.com), a subsidiary of WuXi AppTec (wuxiapptec.com), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier contract development and manufacturing organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate. For more information, please visit: http://www.STApharma.com
WuXi STA Clinical Supply Services (CSS) can provide rapid, agile and reliable supply support for clinical phase I to IV trials and has been manufacturing clinical investigational drugs since 2008. CSS is embedded into the innovative integrated CMC platform of WuXi STA, can truly realize seamless connection from drug product to clinical supply. The customized solution will fully enable pharmaceutical companies to comparator sourcing, primary packaging, secondary packaging, warehouse storage and cold chain distribution, return and destruction to accelerate the process of clinical supply.