Case Studies > Global Clinical Label Creation & Validation

Global Clinical Label Creation & Validation

Company Size
1,000+
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
  • Application Infrastructure & Middleware - Data Exchange & Integration
  • Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries
  • Healthcare & Hospitals
  • Life Sciences
  • Pharmaceuticals
Applicable Functions
  • Business Operation
  • Quality Assurance
Use Cases
  • Process Control & Optimization
  • Regulatory Compliance Monitoring
  • Remote Collaboration
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
  • Lionbridge's specialized label creation and validation team spans 100+ countries and languages, addressing the complexities of global label creation.
  • Their validated network of regulatory and linguistic experts ensures regulatory and linguistic consistency across all markets, languages, and vendors.
  • Lionbridge's phrase library and project management online technology solutions are securely deployed in days to meet evolving needs.
  • The company has an unprecedented scale and dedication to continuous business process optimizations, ensuring flawless delivery and integrity of all assets.
  • Lionbridge's Label Creation & Validation Team is now an integral component of their international clinical labeling process, continuously reviewing and ensuring the accuracy of all assets.
Quantitative Benefit
  • Accelerate global IMP label creation & validation turnaround times from months to weeks or days.
  • Identified hundreds of errors including mistranslations, missing words, and even wrong languages.

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