Global Clinical Label Creation & Validation
Customer Company Size
Large Corporate
Country
- United States
Product
- Lionbridge Label Creation & Validation
- Lionbridge Phrase Library
- Lionbridge Labeling Software Solutions
Tech Stack
- Online Technology Solutions
- Labeling Software Solutions
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Cost Savings
- Customer Satisfaction
- Productivity Improvements
Technology Category
- Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries
- Pharmaceuticals
- Life Sciences
- Healthcare & Hospitals
Applicable Functions
- Quality Assurance
- Business Operation
Use Cases
- Regulatory Compliance Monitoring
- Remote Collaboration
- Process Control & Optimization
Services
- System Integration
About The Customer
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.
The Challenge
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.
The Solution
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.
Operational Impact
Quantitative Benefit
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