Case Studies Global Clinical Label Creation & Validation

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	Global Clinical Label Creation & Validation

Global Clinical Label Creation & Validation

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
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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.

About 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.

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.

Impact #1	Lionbridge's specialized label creation and validation team spans 100+ countries and languages, addressing the complexities of global label creation.
Impact #2	Their validated network of regulatory and linguistic experts ensures regulatory and linguistic consistency across all markets, languages, and vendors.
Impact #3	Lionbridge's phrase library and project management online technology solutions are securely deployed in days to meet evolving needs.

Impact #1

Lionbridge's specialized label creation and validation team spans 100+ countries and languages, addressing the complexities of global label creation.

Impact #2

Their validated network of regulatory and linguistic experts ensures regulatory and linguistic consistency across all markets, languages, and vendors.

Impact #3

Lionbridge's phrase library and project management online technology solutions are securely deployed in days to meet evolving needs.

Benefit #1	Accelerate global IMP label creation & validation turnaround times from months to weeks or days.
Benefit #2	Identified hundreds of errors including mistranslations, missing words, and even wrong languages.

Benefit #1

Accelerate global IMP label creation & validation turnaround times from months to weeks or days.

Benefit #2

Identified hundreds of errors including mistranslations, missing words, and even wrong languages.

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Overview

Global Clinical Label Creation & Validation

Operational Impact

Quantitative Benefit