Global Clinical Label Creation & Validation
公司规模
1,000+
国家
- United States
产品
- Lionbridge Label Creation & Validation
- Lionbridge Phrase Library
- Lionbridge Labeling Software Solutions
技术栈
- Online Technology Solutions
- Labeling Software Solutions
实施规模
- Enterprise-wide Deployment
影响指标
- Cost Savings
- Customer Satisfaction
- Productivity Improvements
技术
- 应用基础设施与中间件 - 数据交换与集成
- 功能应用 - 企业资源规划系统 (ERP)
适用行业
- 医疗保健和医院
- 生命科学
- 药品
适用功能
- 商业运营
- 质量保证
用例
- 过程控制与优化
- 监管合规监控
- 远程协作
服务
- 系统集成
关于客户
Lionbridge Life Sciences is a specialized business unit within Lionbridge Technologies Inc., providing translation and globalization services exclusively to Pharmaceutical and Biotech companies, Clinical Research, and Contract Manufacturing organizations. Recognized by Forbes as one of America’s most Trustworthy companies, Lionbridge serves to maximize global communication effectiveness within the boundaries of a highly regulated, complex, and always-challenging life science environment. Their services span across 100+ countries and languages, addressing the complexities of global label creation and validation.
挑战
With an increasing number of international trials and an ever-changing global regulatory environment, the challenges associated with Investigational Medicinal Product (IMP) labeling grow every day. Lengthening production timelines, errors and inconsistencies, and a demanding process of managing different vendors across global trials are some of the key issues faced. These challenges can lead to delays of four, six, or even eight weeks for a single panel label. Additionally, multiple vendors across studies can result in outright translation and regulatory mistakes, making the process even more demanding for robust organizations.
解决方案
Lionbridge offers a comprehensive labeling solution to address these challenges. Their services include dedicated project management, SME regulatory validation, master label creation, translation (both forward and backward), formatting (DTP), phrase library management and maintenance, certification, and labeling software solutions. By leveraging a validated network of regulatory and linguistic experts, Lionbridge ensures regulatory and linguistic consistency across all markets, languages, and vendors. Their phrase library and project management online technology solutions are securely deployed in days to meet evolving needs. This approach allows for the transfer of a manageable and efficient process and validated labeling assets from trial to trial, region to region, and CRO to CRO.
运营影响
数量效益
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