Clinical trials are increasingly conducted internationally with patients, investigators, trial organizers, and even doctors and clinicians speaking different languages. As a result, many of the clinical studies, research reports, trial sponsor materials, and patient documents such as ICFs (informed consent forms) and PROs (patient reported outcomes) must be accurately translated and validated. Multilingual clinical trials serve several purposes: 1) better patient sampling to cover different ethnic groups, 2) spend reductions with lower labor cost in overseas markets, and 3) enhanced international market entry once the drugs are approved by regulatory authorities such as the FDA, NMPA, and EMA. Stepes is the authority for professional linguistic validation for clinical trials. Our cloud-based, lean localization model provides a much-needed alternative to old-fashioned, ad hoc, and costly linguistic validation services. Better yet, Stepes helps pharmaceutical and CRO companies organize and manage multilingual documents using our state of the art online virtual data rooms. To learn more about Stepes expert clinical trial translation services, please click here.

Within the therapeutic industry, patient-centered clinical solutions and treatment systems are rapidly gaining momentum. There is a growing trend in modern clinical trials that places more importance on the opinions, comments, and complaints by patients, namely patient-reported outcomes (PROs), compared to those coming from clinicians, caregivers, and trial observers. This is why it’s all the more important to accurately translate PROs using linguistic validation processes in order to obtain drug approvals from regulatory authorities in international markets. With Stepes, we have the linguistic subject matter experts and localization best practices to ensure both efficient and quality linguistic validation for all your patient reported outcomes across languages.

Stepes streamlines professional linguistic validation for multilingual clinical trials covering a variety of healthcare and therapeutic areas. Our life sciences translation best practices are designed for simpler, faster linguistic validation of Clinical Outcome Assessments (COAs) for results that’re better than ever.

Forward Translation

The first step of our linguistic validation is to translate the clinical documents with two independent life sciences linguists with the right subject matter knowledge matching the target therapeutic field of study using a process called TEP (translation, editing, proofreading.) These in-country native linguists must be supported by subject matter specific terminology glossary and automatic consistency checking tools to ensure linguistic consistency and technical accuracy of the translated materials.

Content Reconciliation

Once the forward translations are completed by two independent linguists, the resulting translations are systematically compared and reconciled by a third linguist (translation reviewer) with the right specialization in the study’s subject matter area. The goal is to identify and fix all translation quality issues such mistranslation, omissions, inconsistencies, and other translation errors (including cultural misinterpretations) as well as readability issues to produce a target translation.

Back Translation

As the name suggests, back translation is the process of translating the translated content back to its original source language. For linguistic validation in clinical trials, this is the step to translate the reconciled translation back its source language. Depending on the requirements, back translation may be performed by one or two independent linguists who have never seen the original source document. This will allow for unbiased back translation results.

Translation Accuracy Validation and Harmonization

Once the back translation is complete, a qualified linguistic validator is engaged to review the back-translated content against the original source documents to identify any technical accuracy and consistency issues. The validator will work with the translators, project managers, and trial investigators to harmonize the translation and produce the final linguistically validated content.

Cognitive Debriefing

The harmonized translations are then used with patients by the trial investigators in the target language to evaluate if the patients interpret the data and respond to the questions in the same way as the patients in the original source language. This process is often referred to as cognitive debriefing.