Case Report Form Translation

During the clinical trial process, researchers employ a number of tools, such as case report forms. However, with more and more studies being conducted abroad, translation has become an increasingly important component of clinical trial success.

Clinical trials help bring new drugs, treatments and medical devices to market. However, the road to doctors’ offices and pharmacy shelves can be a lengthy one. A treatment’s safety and efficacy must first be studied and established in clinical trials, and approvals gained from regulatory authorities like the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency.

Why Translate Case Report Forms?

Case report forms, also called case study report forms, are questionnaires or instruments used in clinical trial research to facilitate data analysis and test hypotheses. They are based on the study’s protocol and collect specific data about each subject in the clinical trial, including any adverse events.

Clinical trial research often crosses borders. For example, among the 20 largest pharmaceutical companies in the United States, more than half of their study sites are located abroad and more than one-third of their phase III clinical trials are conducted internationally. As a result, good translation is now part and parcel of conducting successful clinical trials.

Case report forms are completed by the local researchers at each participating site. If the forms are paper documents, the information is later entered into a database. Otherwise, using electronic case report forms, also known as eCRFs, the researchers directly enter the information into the database. The data is then validated before being analyzed. The sponsors of the clinical trial typically receive case report forms without identifiable patient information, such as name and social security number.

Experts in Case Report Form Translation

Responsive Translation has been a strategic partner providing translation and validation services to compliance-intensive industries for over 20 years. We specialize in adapting complex translation and quality assurance workflows to meet the most demanding regulatory, quality and budget requirements with our network of specialized, highly-qualified life science translators and editors.

Every project we do undergoes a triple-check quality assurance process, in addition to strict project-specific protocols.

Due to our experience and attention to quality assurance, you will find that our case report form translation is unparalleled and backed by a quality and satisfaction guarantee.

To discuss your translation requirements, or if you would like more information about Responsive Translation’s suite of clinical trial translation services, please contact us at +1-212-355-4455 or services@resptrans.com.

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