Clinical trials are used by doctors and researchers around the world and play a big role in medical advancements. The 20 largest pharmaceutical companies in the US, for example, conduct about a third of their clinical trials in foreign countries. As the clinical trial market has quickly expanded around the world in recent years, the need for clinical trial document translation services has grown. At the same time, regulatory demands have increased. A professional translation company can help guarantee patient safety during clinical trials, and make sure that pharmaceutical companies are in compliance with regulations. Medical translation services for clinical trials include translating, editing/proofreading, back translation, and clinical reviews and conferences to make sure the translation is of the highest quality and well-understood by the local target audience.

Proper translation of clinical trials is important to patients, test subjects, doctors, researchers, and pharmaceutical companies. Patients and test subjects need to understand consent forms related to clinical trials to ensure their safety. Even outside of the US, the FDA (Food and Drug Administration) requires pharmaceutical companies to comply with ethical standards. Documentation for FDA regulations must be translated into local languages when clinical trials are performed abroad. These regulations go beyond the FDA’s IND (Investigational New Drug) and NDA (New Drug Application) regulations. The Declaration of Helsinki, created by the WMA (World Medical Association), establishes the global standards for human research ethics. The declaration states that patients must be adequately informed when receiving medical services and that services must take into account each patient’s specific needs. Pharmaceutical companies and CROs (Clinical Research Organizations) working outside of the US need to translate many different types of documents, including:

• Study protocols
• Case report forms
• Informed consent forms
• Patient dairy
• Ethics committee submissions
• Protocol synopses
• Investigator Brochures
• Serious adverse event reports

A company that provides medical translation services can put all of these documents together into a single report publication for researchers.

It is extremely important to hire a professional translation company to translate clinical trials.

The benefits of properly-translated clinical trial documents include:

• Enhanced safety of patients and test subjects
• Greater access to medical services in certain low-income countries where clinical trials may be the only treatment option
• Helping pharmaceutical companies successfully meet application requirements when applying for IND and/or NDA
• Less risk to pharmaceutical companies
• Improved medical research capabilities around the world
• Improved communication, trust, and cooperation among doctors, patients, and pharmaceutical companies

The potential risks of translation errors include:

• Physical harm to and even death of patients or test subjects
• Non-compliance by patients due to not understanding prescriptions, or not knowing how to treat potential side effects or adequately follow up with medical professionals
• Failed IND and NDA applications for pharmaceutical companies who have wasted time and money on a non-qualified translation service
• Lawsuits and other legal problems as well as loss of credibility for pharmaceutical companies
• Lack of advancements in medical research
• Decrease in the ability of medical professionals to understand clinical trial findings

A professional translation company can eliminate these risks. Patients can be kept safer and more well-informed, and pharmaceutical companies can rest assured that they would not face any legal issues. Translations should be performed at all stages of the clinical trial process, from the research stage before a drug is approved for human testing, to the evaluation phase where its safety and effectiveness are measured, during production and marketing phases, and after it has been FDA-approved for use among the general population.

If pharmaceutical companies or other medical organizations try to cut costs by skipping the clinical trial translation step, it can result in lawsuits or rejection by regulating authorities. This type of translation should only be provided by a professional translation company specializing in medical translation services. Translators for clinical trials need to understand medical terminology and jargon. Proper translation by a team of professionals improves clinical trials for patients, doctors, and pharmaceutical companies alike.

Today, many clinical trials are conducted globally, and language services have become an integral part of clinical trials. EC Innovations has been working with many of today’s leading companies in medicine and the clinical trial Industries for over 22 years.

EC Innovations Life Sciences has been providing medical and clinical research translation services to CROs, sponsors, IRB, and hospital systems since 1997. We offer accurate, consistent, and comprehensible translations that meet all regulatory and local standards.