Clinical Trial Translations

Clinical trials are part of medical device and pharmaceutical product approval processes. There are special protocols and requirements that usually apply to clinical translations. Depending on the instrument, population and location those protocols might be different. Our approach towards the methodology of clinical trials is to lead a personalized customized plan for each project. The reason we prefer a customized rather than a generalized approach is that clinical trial protocols, needs, regulations, restrictions, timeframes, localities and uses widely differ. Clinical trial regulations can differ from one region to another, however, there is a set of specifications for application dossiers for medicine registration, this set of modules is accepted by many countries including Japan, China, the EU, the USA, Canada, and more. This set of Modules is called CTD- Common Technical Document.

Most CROs nowadays use an eTMF system to manage and document their trial documentation, applications, and data in a set of verified forms and templates already divided into countries. Our API software solution will enable us to directly integrate our TMS and linguistic validation platforms into your eTMF system so that your trial follow is not disrupted by any software challenges. Furthermore, a common practice today is to launch mobile applications for clinical trial data gathering and follow-up.

Our team of software engineers and designers will provide linguistic solutions to your trial apps and e-forms with a seamless, prompt, and secure approach.

Cognitive Debriefing – a process in which a series of interviews with patients or subjects that the instrument is directed to, is performed. The interviews aim to assess the understanding of those patients and locate any linguistic, cultural, or clinical terminology issues before finally launching the instrument.

Usability Testing – In usability testing the layout, templates, frames, type phase, colors, and other visual components are tested on the subject population. Instruments electronic Clinical Outcome Assessment ( eCOA ) are assessed at this stage to further help coders and designers properly build the electronic platforms.

The following are some of the processes we include in our customized working diagrams for clinical trial translations.

Forward Translation- two target language native medical translators with proper medical field experience background perform two separate translations.

Reconcile Version- After the two translations have been generated a discussion is performed to create one version out of the two.

Back Translation- one source language native translator with proper medical background performs back translation to the source language. Consequently, a discussion is held to compare the source to the back translation and changes to the translation are done accordingly if needed.

SME Review- Subject-of-matter expert review is a process in which an expert, usually a specialized medical doctor practicing medicine in a specific country, performs a review of the documents and provides a clinical view of the generated document.