Language Translation In Clinical Trials

by Target Language Translation Services

- December 23 2021

Bringing a new drug to market is a long-term and expensive process. Pharmaceutical companies can spend up to 10 years and more, and over $500 million to get a new drug to market. Since more and more clinical research and drug manufacturing are being done in multiple countries and in multiple languages, quality language services can help bring a drug to market faster and can help streamline the clinical trial process. Translation may be required at many stages, including clinical research, regulatory submission and review, production and marketing.

comprehensive translation services

Target Language Translation provides comprehensive translation services, which meet your exacting needs for clinical research, trials, and studies.

Our clinical trial translation provides clear, precise, and cost-effective documentation that is easily and clearly understood by all participants in the process. A wide range of documents is required, each playing a critical role in the success of the trial. Some issues relating to clinical trial translation follow:

Patient Information and Trial Subject Documentation Has Unique Translation Requirements

From recruiting documents to surveys and evaluations, documents that address patients and subjects directly must be translated in a way that takes literacy, education, and cultural issues into consideration. At TLT, our native-speaking translators have innate knowledge of the cultural aspects of correct translation, along with specialized training and experience in medical and life science disciplines. For patient and study subject documents, their knowledge of—and attention paid to—regional and local idioms enable them to translate your message not only precisely, but also in language that is relevant and clear to the target audience. Typical documents include:

Patient Information Leaflets (PIL)

Informed Consent Forms (ICF)

Doctor and Patient Guides

Case Report Forms (CRF)

Patient Questionnaires

Drug Inserts

Drug Study Labels

Clinical Protocols

Regulatory Documents

Proper translations are not simply word-for-word duplication of source documents, but must provide necessary information in a form that is fully understood by participants, in the same tone as your original communication. Acceptance, compliance, and precise reporting of subjects’ experiences are essential goals that can only be achieved by experienced translators.

Precise Translations for Clinicians and Research Administrators Are Critical

Proper execution of research protocols and complete and precise reporting and administration of the trial, study, or research requires precise and meticulous translation of all documents into the target language. The specialized translators at TLT, along with our experienced project managers, know and understand the unique needs and vocabulary used by these crucial staff members and administrators. Our translators’ individual training and experience in life science and medical disciplines and their fluency as native speakers guides them in preparing translations that precisely translate every nuance of your original materials. Our ISO9001-2005-certified quality control processes assure our clients of impeccable quality for documents like:

Protocol Documentation and Investigator Brochures

Summaries of Product Characteristics

Clinician Educational Materials

Case Report Forms

Adverse and Severe Events Reporting Documents

Study Documentation and Reports

Regulatory and Legal Documents Require Specific Translation Expertise

Documents submitted to local regulatory bodies, government agencies, and other authorities require not only precision but also thorough understanding of the unique language utilized in such documents. At TLT, we correctly translate and format such documents to meet the most exacting standards. Our experience with regulatory and legal documents in all of our provided languages makes sure that your documentation is translated to meet all of your needs.

Professional Translations Into English From the Language of Your Clinical Study

Providing precise and normalized translations from the language of the location of any research study or clinical trial into English is another responsibility of your translation services provider. Patient and subject surveys and patient recorded outcome forms require precise translation for proper interpretation. Clinicians’ reports must be translated precisely when creating English language documentation for the research project, trial, or study. At TLT, we can provide those translations quickly, precisely, and formatted to meet your every need.

Contact us today to learn more about our professional clinical trial translation. Let’s eliminate the language barrier between you and your clients!

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