Clinical label design is customizable workflow for label text creation, translation and validation across more than 100 markets and languages. A group of expansive network of qualified translators and regulatory experts enables pharmaceutical and biotechnology organizations to reduce the overall label cycle times and simplify global label creation. Key benefits are Greater Flexibility – From a single label in a single market to multiple labels across 60 markets simultaneously, organizations have increased flexibility to tailor the clinical labeling process to their specific needs.
Increased Efficiency – Customizable workflow generates high quality, translated content that meets target audiences, while reducing turnaround times and increasing overall operational efficiencies.
Improved consistency and error reduction – By providing an end-to-end solution, organizations can decrease the added complexities that often come with working with multiple vendors, avoiding translation errors and increasing consistency and speed without sacrificing quality.
Regulatory Conformity – Ensure 100 percent compliance by leveraging expertise with local Health Authorities’ labeling guidelines (FDA, EMA, PDMA and more), along with ISO 9001, ISO 13485 (including risk management) and EN 17000.
Companies providing clinical labeling services embrace the challenge of meeting the demanding timelines for your clinical trial labels. They understand the need to comply with local language labeling requirements, label performance, ease of use, specialized labeling (cryogenic labels, wrap-around labels, piggyback labels, xylene-resistant labels, syringe labels, tamper-evident labels, histology labels, autoclave-resistant labels, etc.) and of course ensuring the accuracy of information that goes into the sampling of patients.
During drug development, companies may utilize a variety of labeling-related tools that employ target labeling to facilitate drug development, while simultaneously aligning desired marketing and labeling objectives with the development program design or study design. Some of the clinical labeling tools utilized during drug development are: Investigator Brochure (IB), Target Labeling (TL)/ Target Profile, Development Core Data Sheet (DCDS), Development Core Safety Information (DCSI), FDA Target Product Profile (TPP). It is very important for companies to employ a modular approach while collecting the evolving safety and efficacy information across various types of clinical labels. This would satisfy the need to help investigators and sponsors more effectively by presenting and updating a focused, dedicated DCSI section that can conveniently be placed under these different clinical categories. Furthermore, DCSI develops into the CCSI that is included in the first Company Core Data Sheet (CDS) and is utilized for the product's entry into the market.
Clinical labeling companies supplements a dedicated clinical supply chain service provider and leverages purpose-built, integrated facilities, a global presence and the information systems and flexibility to allow unparalleled visibility and control while offering time-saving, seamless transition opportunities throughout your clinical supply chain.
They hae advanced inspection software, full in-house print capabilities, translation and regulatory approval management process, centralized web-based document management/routing platform, are specifically designed to reduce the overall label cycle times.
Clinical trial labeling requires a higher level of oversight and management than a commercial labeling operation in order to protect the integrity of blind, as well as meet stringent regulatory controls.
By combining clinical trial project management expertise and expansive global reach companies are able to provide a clinical labeling model that integrates regulatory, packaging and clinical logistics capabilities to deliver improved timelines and more accurate allocation of clinical trial materials. Backed by years of pharmaceutical and printing industry experience, no company better understands your need for error-free clinical labels delivered on time, every time.