Clinical

We work with the world’s largest pharmaceutical and biotech companies to help them through global challenges such as patient recruitment and clinical protocols.

Healthcare, biotech, and pharmaceutical translation are highly specialised subject areas that require an in-depth knowledge of the field as linguists are required to use the relevant terminology to ensure that clinical documentation translations are accurate and reliable.

Translating clinical trial dossiers is a vital step in the clinical trial process, and is exceedingly important for any global organisation in the medical sector.

From preclinical throughout each study phase all the way to product launch, you’ll want to ensure that your translations are localised.

We’ll select the most appropriate team of medical professionals for your clinical trial translation project while ensuring we have the industry knowledge and language expertise to accurately translate your documentation.

We can help with translation and linguistic validation for:

  • ICFs (Informed Consent Forms)
  • Clinical protocols & synopsis
  • Investigator brochures
  • RA (Regulatory Authority) / EC (Ethics Committee) correspondence
  • Clinical Trial Agreements
  • Clinical Study Report
  • Patient recruitment material
  • Patient diaries and booklets
  • Adjudication
  • COA/ eCOA (electronic Clinical Outcome Assessment)

Our services

LingVal (Linguistic Validation) & eCOAProduct development and launch

  • Forward & back translation
  • Reconciliation
  • Harmonisation
  • Screenshot review
  • Digitization migration
  • Updates post-CogDev
  • Patient mobile app localization

ClinicalPatient recruitment and clinical protocols

  • ICFs (Informed Consent Forms)
  • Clinical protocols & synopsis
  • Investigator brochures
  • RA (Regulatory Authority) / EC (Ethics Committee) correspondence
  • Clinical Trial Agreements
  • Clinical Study Report
  • Patient recruitment material
  • Patient diaries and booklets
  • Adjudication
  • COA/ eCOA (electronic Clinical Outcome Assessment)

Medical DevicesPrecise end-to-end translations

  • Patents for medical devices
  • Package labels and inserts
  • Operating, maintenance, installation and instruction manuals
  • Development Safety Update Reports (DSURs)
  • Regulatory compliance documents
  • Software user interfaces and documentation
  • Suspected unexpected serious adverse reactions (SUSARs)


LegalSafety and pharmacovigilance

  • AEs (Adverse Events) / SAEs (Serious Adverse Event)
  • Product recalls
  • Good Practices (GxP)
  • Safety specialist

MarketingBrand management and localisation

  • Press releases
  • Newsletters
  • Websites
  • Investor relations
  • Code of conducts
  • Legal translations (M&A; eDiscovery; litigation; contracts)

Learning & DevelopmentLearning modules, interpretation, and internal compliance

  • Educational material
  • Sales training modules
  • Compliance modules
  • eLearning localization


Why our clients choose us: the 3Ts of TOPPAN.

Talent

Talent

  • We strive to attract and develop the best talent in the industry for first-class service to our customers
  • We are intentional in creating a respectful, diverse, and ambitious team
  • We hand-pick native-speaking expert linguists and always pay them fairly
Technology

Technology

  • We build our tech with trusted expert advice for your industry content needs
  • Our proprietary tech platform, Stream, is easy to use and easy to implement
  • We continuously innovate with the most appropriate tech through a long-term approach
Tailored to you

Tailored to you

  • We partner with your team through consultative engagement
  • We focus on addressing your specific pain points with bespoke solutions
  • We deliver first-class service with operational excellence – quality, security, and on-time delivery
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