Translation for Clinical Trials

Clinical trials are generally considered to be medical or health-related research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. The trial follows a carefully controlled protocol, a study plan that describes what will be done in the study, how it will be conducted, and why each part of the study is necessary.

Clinical trials should be conducted in accordance with the ethical principles stated in the Declaration of Helsinki which are consistent with Good Clinical Practice (GCP) guidelines. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), a unique project bringing together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions, developed guidelines in order to provide clinical trials with a unified standard and provide public assurance that the rights, safety, and wellbeing of trial subjects are protected. The guidelines take into consideration the current good clinical practices (GCP) of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO).

Bringing a new drug to market is a lengthy 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. Moreover, expansion of the EU block into new member countries is also driving increased demand for medical and pharmaceutical translation services.

Global Translation is a leading provider of specialized translation services to leading pharmaceutical companies and contract research organizations (CRO). The documents we translate 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

Customers in the Pharmaceutical, Medical Device and Healthcare industries have come to rely on our team of subject-matter experts for even the most complex translations. Our human resources include linguists with experience in genetics, biochemistry, biotechnology, chemistry, pharmacology, toxicology and more.