Will you need to have an investigator’s brochure (IB) in another language?

During the drug development and approval process, good clinical practice and regulatory compliance demand careful recording of clinical and non-clinical data in documents such as investigator’s brochures, informed consent forms, case report forms and clinical study reports.

The IB is where trial sponsors compile data relating to the drug and its study in human subjects. This document is used by investigators to ensure protocol compliance and is often submitted to regulatory bodies as part of new drug applications. For many clinical trials, documents must be translated into more than one language. Proper translation of an investigator’s brochure is paramount to ensuring that multi-country clinical trials and marketing are not unfairly derailed.

Wherever you choose to expand, Responsive Translation can help you present an effective and accurate investigator’s brochure in any of 200 languages.

Inside a Successful Investigator's Brochure

With a network of highly-qualified medical and clinical translators and subject matter experts, Responsive Translation provides translation services for investigator’s brochures into most languages and dialects. We also offer rigorous validation and review services, as well as medical writing services if an original investigator's brochure is required in a foreign language.

We have found that successful investigator’s brochures typically contain the following elements, according to the ICH’s guidelines:

• Title page.
• Confidentiality statement.
• Table of contents.
• A brief summary describing the pharmaceutical, physical, toxicological, clinical and other information concerning the current stage of the drug’s investigation.
• A brief introduction containing the drug’s chemical name, its active ingredients, the reason for pursuing research, therapeutic indications and the approach for evaluating the drug.
• A description of the drug’s physical, pharmaceutical and chemical properties, and how it was formulated.
• A non-clinical studies section that discusses the methodology and results of relevant toxicology, pharmacokinetic and pharmacology studies of the drug using animals.
• A clinical studies section that discusses and reports the effects of the drug on humans, focusing on pharmacokinetics, safety, efficacy and experiences as a result of marketing.
• A summary of the data presented and guidance to investigators using the most current information and interpretations.

Investigator’s brochures must be updated each year, or even more frequently depending on the stage of the clinical trial.

Trouble-Free Translation Services

Responsive Translation has become synonymous with quality and dependability. We’ve honed our clinical trial translation services and quality assurance workflows over three decades with clients like Merck, Pfizer, Bristol-Myers Squibb, Johnson & Johnson and Sanyo Pharma.

We only use highly-qualified and experienced clinical and medical translators and subject matter experts who are native speakers in the target language and well-versed in the target culture. Yet with our streamlined ISO-certified processes and advanced terminology management, Responsive Translation works up to 60% faster than our agency competitors and always at a fair price.

To discuss your specific IB requirements, or if you would like more information on Responsive Translation’s range of clinical trial translation services, please contact us at +1-212-818-1102 or [email protected].