Clinical Research and Trials Translations

• Clinical research and trials translations
• Success stories

Regulatory complexities, patient access, increased competition, new technology – there are so many obstacles that pharmaceutical companies are facing when conducting a clinical trial. When you consider the spiraling cost and high attrition rates, it is easy to see why clinical professionals like yourself have to plan every clinical trial very meticulously, treating all aspects as critical to its success.

As globalisation has opened the door for global clinical trials in sites, language services have become one of these critical pieces of the puzzle as well. Inability to recruit or retain patients, delays in the approval process or major deviations from protocol, improper collection and collation of data are just some of the key pains that would result from ignoring this aspect. Not to mention the most important aspect – failure to comply with the ethical standards and presenting inaccurate information to the patients.

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

Why do so many pharmaceuticals, 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 know the translation requirements, procedures, processes and workflows involved – European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) or International Society for Pharmacoeconomics and Outcomes Research (ISPOR) principles of good practice for the translation and cultural adaptation (TCA) of Patient Reported Outcomes (PROs) measures.
• We improve continuously to benefit from any methodological advances and provide you with a detailed linguistic validation process.

How do we ensure high quality?

– We follow the translation process recommended by the ISPOR, EORTC or WHO:

• Analysis of the source text before the actual translation process
• Forward translation of the source text into the target language
• If two forward translations are created, we reconcile the two translations into one target translation
• Back translation of the text into the original language
• Evaluation of the back-translated versions of the document with the original. Issues are resolved and a final translation is generated
• Harmonization of back translations of multiple language versions in order to achieve semantic and conceptual equivalence of all translations.
• Final proofreading of the text

– We build translation memories and glossaries

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

Which translation services does Intertranslations provide?

All our professional translation services are provided in line with the ISO 17100:2015 and ISO 9001:2015 certifications we hold.

• Translation
• Revision
• Proofreading
• Back-translation
• Certification
• Desktop publishing

What types of clinical trial documentation do we translate?

We translate any essential document for the conduct of a clinical trial, to confirm the validity of the trial conduct and the integrity of data collected. Whether it regards documents from before the clinical phase of the trial, during the clinical conduct or after completion or termination of the trial, we implement quality control throughout the entire translation process.

List of documents:

• investigator’s brochure
• protocol and amendments
• case report form
• informed consent forms
• financial agreements and legal contracts
• approval/favourable opinion of Institutional Review Board (IRB) /Independent Ethics Committee (IEC)
• labels
• patient diaries
• patient information leaflets
• patient reported outcomes
• ethical committees and regulatory bodies correspondence translations
• recruitment materials
• monitoring reports
• audit documentation
• clinical trial reports

For more information, contact one of our clinical trial translation experts today.