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Clinical Research and Trials Translation Services

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Clinical Research and Trials Translations

Accelerate your expansion to Europe

From Lab to World: The Art and Science of Clinical Translations

The pharmaceutical industry grapples with regulatory complexities, patient accessibility, heightened competition, and technological advancements, all posing significant hurdles during clinical research. Amid escalating costs and elevated attrition rates, meticulous planning becomes imperative for clinical professionals like yourself. Every aspect is crucial to ensuring the success of each research study and language services have emerged as a crucial component in this landscape.

Overlooking this facet could lead to critical issues such as difficulties in patient recruitment or retention, delays in approval processes, substantial deviations from protocols, and incorrect data collection. Moreover, the most significant concern – the failure to adhere to ethical standards and the presentation of inaccurate information to the participants in a clinical study. 

Partner with our expert translation services proficient in medical terminology, regulatory standards, and well-organized project management to navigate these challenges and ensure precise, timely, and compliant translations for successful clinical research in study sites in Europe.

By assigning your clinical research translations projects to Intertranslations, you overcome these challenges. 

Why do pharmaceutical, biotech companies and contract research organizations request our services? 

We use accredited, professional and qualified translators who are native speakers, with numerous years of experience in clinical trial terminology.
We understand the regulations and work in symbiosis with the client to achieve the final goal – accurate translation, semantic and conceptual equivalence.
We are ISO 27100:2013 certified and have implemented procedures to ensure your clinical trials information remains confidential
We have a comprehensive understanding of the translation requirements, procedures, processes, and workflows. We are well-versed in adhering to the principles of good practice for the Translation and Cultural Adaptation (TCA) of Patient Reported Outcomes (PROs) measures. These principles are established by respected organizations such as the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) and the International Society for Pharmacoeconomic and Outcomes Research (ISPOR).
We consistently improve our methods to leverage advancements, ensuring a comprehensive linguistic validation process tailored for your benefit.

1. We follow the translation process recommended by the ISPOR, Food and Drug Administration, EORTC or WHO: 

  • Pre-translation analysis of the source text. 
  • Forward translation into the target language. 
  • Reconciliation of multiple forward translations into a single target translation if necessary.
  • Back translation into the original language. 
  • Evaluation and comparison of back-translated versions with the original text; resolution of discrepancies to create a final translation. 
  • Alignment and harmonization of back-translations across multiple languages to ensure semantic and conceptual equivalence.
  • Final proofreading and refinement of the translated text.

2. We create translation memories and glossaries  

3. We test our clinical translators independently – cognitive interviewing, readability testing 

What types of clinical trial documentation do we translate?

Investigator’s Brochure 
Protocol and Amendments 
Case Report Form 
Financial Agreements and Legal Contracts 
Approval/Favorable Opinion of Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
Labels 
Patient Diaries 
Informed Consent Forms 
Patient Reported Outcomes 
Ethical Committees and Regulatory Bodies Correspondence Translations 
Recruitment Materials 
Monitoring Reports 
Audit Documentation 
Clinical Trial Reports 
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Break Language Barriers with Us!

Contact one of our clinical research translation experts today!

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