Translation services for clinical trials

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

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