Clinical

Clinical_InsetImage_Main Lionbridge Life Sciences has extensive experience in global clinical trial translation, providing consultative, end-to-end services for a wide range of documentation. Our clinical teams can scale programs for trials of all sizes, offering service and support on a global scale to produce accurate, consistent translations and the greatest impact for your message across many languages, markets and cultures. Here’s how:

 

Cultural Focus | Quality Standards & Methodologies | Credibility & Integrity | Linguistic Validation | Patient Recruitment | Labeling & Packaging

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Culturally focused partner

Translating CT documents is not just a a question of language and dialect. It requires a level of rigor and experience unique to Lionbridge Life Sciences. Different documents have different target audiences – patients, principal investigators, regulating bodies – and we understand both the language of the audience and of the trial, while always keeping the original content in mind. We focus on:

  • Knowledge of clinical trial requirements, country by country
  • Regulatory submission and compliance support
  • Cultural consultation, market by market
  • True transcreation vs. conventional localization
  • Consistently high quality, fast turnaround and efficient throughput
  • Global project management

Clinical Trial Translation Services

  • Patient Reported Outcomes (PROs) and ePRO with Linguistic Validation and Cognitive Debriefing
  • Scales and Quality of Life (QoL) Instruments
  • Summaries of Product Characteristics (SmPC)
  • Adverse and Severe Adverse Events
  • Patient Recruitment, Questionnaires, Diaries and Interpretations
  • Patient and Clinician Education Materials
  • Patient Informed Consent Forms (ICFs) and Patient Information Leaflets (PILs)
  • Protocols and Case Report Forms (CRF, eCRF)
  • Investigator Brochures
  • Physician Letters
  • Site Documentation and Reports
  • Packaging and Labeling
  • Import/Export Permits
  • Clinical Trial Recruitment and Retention

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Quality standards and methodologies

The nature of CT documents requires the highest quality standards, which is why our translators are scientifically educated and strictly adhere to distinct and complex methodologies for each document to ensure accuracy and layout. We offer:

  • Full linguistic validation and cognitive debriefing services
  • Well-structured ISPOR, ISOQOL and EORTC compliant methodology
  • Support for specific requirements and quick turnaround times for certain types of CT documentation, such as Adverse Events

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Unmatched credibility and complete confidentiality

Our integrity as a language service provider is built on an ability to maintain complete confidentiality through the entire process. Lionbridge Life Sciences has established tight security protocols for our IT infrastructure and personnel, ensuring full compliance in operations, policies and procedures to meet regulatory standards. Our credibility is backed by active memberships and strong relationships with:

  • ISPOR and its special interest group for translations
  • IAC and SIG committees for ISOQOL
  • FDA, EMA, Japanese Review Board and other notifying bodies

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PRO, ePRO and eCOA linguistic validation services

Lionbridge Life Sciences is known for the strength of our linguistic validation services – in which translated text is actively tested with patients in the target population and target language group through cognitive debriefing interviews, conceptual and cultural analyses and a thorough translation review process led by senior-level clinical translators and validated by qualified clinicians. We offer:

  • Largest pool of expert in-country resources of any translation provider to ensure cultural relevance and comprehension of instruments among test subjects
  • Five dedicated Life Sciences Centers of Excellence and clinical trial service teams across the globe – all ISO (9001 and 13485) certified
  • Cognitive debriefing through comprehensive interviews performed with in-country patients in the disease state ensuring clarity, intelligibility, appropriateness and cultural relevance
  • Multilingual harmonization across all test languages to guarantee best possible

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Global patient recruitment and retention

With the growth of clinical trials on a global scale, enrolling and retaining qualified patients poses an increasingly global challenge. A challenge that can lead to costly delays, missed deadlines and lost market share. At Lionbridge Life Sciences, we understand that language and culture play a significant role when recruiting patients from one country to the next – that what you say, and how you say it, really does matter. We’ll partner with you to deliver tailored, effective communications that work seamlessly across the global community while speaking appropriately to each local audience. Our proven cultural expertise, knowledgeable translation services and centralized quality control can help improve your global patient recruitment and retention, and ultimately the success of your clinical trial. We offer:

  • Translation and Localization
  • Cultural Evaluations and Transcreation
  • Content Development and Support
  • Multimedia Campaigns (digital, print, online, TV, radio)
  • Web Development and Publishing
  • Call Centers (scripts, interpreters)
  • SMS Research
  • SEO/SEM Benchmarking

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Labeling and Packaging for Clinical Trials… and Beyond

This is a pivotal moment for global pharmaceutical companies and CROs: As the clinical trial landscape broadens, industry regulations grow increasingly complex and life science organizations must now localize labeling – including inserts, manuals and labels – at every touch point. That’s where our global experts come in. We have the knowledge and know-how to provide expert support in all aspects of pharmaceutical labeling – from sourcing country-specific labeling requirements to multilingual translation and flawless linguistic validations. We offer:

  • High-quality labeling and packaging services, including artwork preparation (label, secondary packaging components), Structured Product Labeling (SPL), labeling updates and amendments, Product Information Leaflets (PIL), patient handbooks, data sheets
  • ISO certifications and rigorous quality methodologies designed specifically for clinical labeling and applied across our specialized Life Sciences Centers of Excellence
  • Innovative technology, such as SaaS-based tools for project submission, linguistic asset management and reporting that can improve cost efficiencies and accelerate timelines
  • Auditable processes tailored to the pharmaceutical industry