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.

Customized Approach

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 trials protocols, needs, regulations, restrictions, timeframes, localities and uses widely differ.

Regulatory Requirments

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, USA, Canada, and more. This set of Modules is called CTD- Common Technical Document.

The CTD dossier is divided into five main modules :

Module 1: Administrative information and prescribing information.

Module 2: Overviews and Summaries of Modules 3–5 Module.

Module 3: Quality (pharmaceutical documentation).

Module 4: Non-clinical reports (pharmacology/ toxicology).

Module 5: Clinical study reports (clinical trials).

Modules 2-5 are harmonized across the countries that accept CTD, while Module 1 is subject to local regulations.

Our experts will smoothly walk you through migrating your application dossiers seamlessly as our platform has already customized implemented frameworks to meet the specifications of the modules as well as eCTD 4,0, alongside local modules (module 1). We can integrate your frameworks and already existing templates with our platform as well to create a more convenient and familiar working environment for your team.

Digital Integration

Most CROs nowadays use an eTMF system to manage and document their trial documentations, 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.

Translation Milestones

The following are some of the procesures 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.

Cognitive Debriefing– is 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.

We Translate

  • Patient Recruitment and Retention Materials
  • Patient Informed Consent Forms
  • Patient Questionnaires, Surveys, and Interactive Media
  • Package Labeling
  • Patient Reported Outcomes
  • Adverse event forms
  • Patient Instructions and Information

Our Innovations

  • Manage your trial on our digital platform:

Our user-friendly project management tool allows your project manager to manage several language translation migration processes simultaneously.

  • Invite your reviewers/regulators/ Validators to our platform:

Our platform enables your reviewers to have full and live access to the whole process of translation, validation, and review.

  • Import your TM and continue building it:

Our platform helps you import your translation memories into our system, furthermore unique translation memory folders will be created for you and can be divided into projects and sections.

  • Use our QA system and customize functions:

Our platform has a built-in QA system that can be customized according to your needs which usually differ with projects, localities, jurisdictions, and regulatory updates.

  • Choose your team:

Our platform includes a group of linguistic, clinical, regulatory, design, and coding experts from which you can choose your team.

  • Use our Medical resources:

As an exclusively medically specialized agency, our platform includes the most updated medical terminology dictionaries for over 100 languages, both static and online dictionaries are included.

  • Get a clinician’s view:

Many times, you might need to consult a local clinician for a linguistic issue, our platform provides you the ability to invite a clinician to a discussion or a consultation on the platform.

  • Manage and view cognitive debriefing live online:

We have built the world’s first cognitive debriefing management platform, which manages both patient recordings, video. interviews, summary reports, discussions, and usability testing.