Translation services for clinical trials in Israel and the rest of the world


 

A clinical trial is a type of medical research that analyzes the efficacy and safety of treatments, drugs and tests designed for use on human subjects. If an innovative development is found to be safe and effective, it may become the future standard treatment for relevant target populations.

Clinical trials are meticulously planned and undergo audits and various approval processes; consequently, they also involve high costs to the pharmaceutical companies until approval is received for the particular treatment, medicine, medical device or other health product.

Clinical trials are conducted to achieve various objectives, including:

–   to analyze the efficacy and safety of new medicines that have not yet been approved by the supervisory authorities in Europe or in the United States, such as the FDA;

–   to analyze new applications for medicines that have already been approved by regulatory authorities internationally;

–   to ascertain the optimal mode of administration of medicines, such as orally or intravenously;

–   to analyze the efficacy and safety of using alternative medicinal products, such as medicinal plants, medical cannabis, food supplements or herbs;

–   to discover new ways to diagnose or monitor the progression of a particular illness;

–   to analyze the efficacy and safety of various medicines or medical procedures designed to alleviate emerging symptoms due to a particular medical condition.

Why are translation services important to a clinical trial?

Clinical trials are subject to stringent regulations and various approvals, which depend, to a large extent, on the quality of the translation that is submitted to the approving authority.

Due to the fact that clinical trials are often conducted in various countries speaking a variety of languages, high-quality translation services can contribute to the clinical trial process and shorten the timeframe until the treatment or test becomes available for use. Translations are needed at various stages, from the clinical research stage and until the findings are submitted for regulatory approval and auditing.

High-quality translations are also critical when at issue is information being provided to the participants in the clinical trial. Dor ensures that all of the information is correct and precise and according to the investigator’s intention.

What services does Dor provide?

Dor provides comprehensive translation services for all research documents that need to be translated and prepared, in conformity with the regulatory requirements that governs the conduct of clinical trials in Israel:

–   informed consent forms

–   protocols

–   regulatory documents

–   medical documents and reports

–   labels and pamphlets

–   usage instructions

–   materials for clinical trial participants, such as:

  • questionnaires
  • diaries
  • applications and software
  • recruitment support materials

What languages do we translate?

We provide translation services for all languages, especially the ones required for the conduct of clinical trials in Israel:

–   English

–   Hebrew

–   Arabic

–   Russian

Translation checking and translation certificates

Every translation is checked by a linguistic expert. Upon request, we can also provide linguistic double-checking [bilingual editing?] and a translation certificate.

What makes Dor’s translation services the most professional?

Ÿ   Superior quality

Stringent quality assurance procedures complying with international translation standard ISO 17100.

Ÿ   Specialization in translations of clinical trial and other medical content

Due to our extensive experience and amassed knowledge in the field of clinical trials, we are highly proficient in translating medical content and in medical terminology.

Ÿ   Personalized advice on content

Beyond performing the translation itself, our translators also review the wordings and their compatibility with the specific research study and the local regulations in Israel.

Ÿ   Precise terminology

We are meticulous about precise medical terminology and refer to the location, the objectives of the treatment or test, the suitability of the language for the target audience and the regulatory requirements.

Ÿ   In-depth familiarity with local regulations

We have considerable experience and familiarity with medical regulations in Israel and in other countries.

Ÿ   Quality and efficiency of the service

We provide personal attention, from initial contact and throughout the entire process until final submissions of the translations. Our clients are confident in our ability to be fully available, to strictly comply with their defined deadlines and to provide optimal translation quality.