Localization challenges of Clinical Trials

Globalization of clinical trials has led to more strict country-specific regulatory requirements, increased quality expectations of translated content, and faster turnaround time. To ensure the successful conduct of the trials outside the country of origin and above all the patients' safety, it is essential that all the processes are regulatory-compliant and well-documented. Documents, such as clinical trial protocols, Clinical Trial Agreements (CTACTAs), Informed Consent Forms (ICFs), Patient-Reported Outcomes Outcome questionnaires (PROs) and Clinical Outcome Assessments (COAs) need to be properly localized and accurately translated across languages and cultures. Wordbee provides solutions that optimize the work of the virtual teams involved in the translation and localization process.

Wordbee solutions

Workflow Automation

Inconsistencies and subjectivity are hard to avoid during the translation and revision processes involving multiple revisers and proofreaders. With In Wordbee you have the option to automate your processes based on pre-defined workflow templates to minimize the risk of human errors and decrease turnaround times and costs. You can, for example, automatically propose jobs to groups of suppliers or to a client company. After a translation or revision job is has been completed, you can automatically run a Quality Assurance (QA) job to check for translation or formatting errors. When a project is completedall the steps in the project are finalized, the status of the project will automatically be set to “Completed”. All the The financial related tasks, such as quotes and invoices, are generated automatically as well reducing the workload of the project managers. Automation improves collaboration of your virtual teams, leading to increased productivity, consistency and quality.Image Removed

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Translation and Linguistic Validation Workflow

Create standardized forward-backwards linguistic validation workflows according to the best COAs PRO and COA translation practices to ensure , ensuring that you meet the regulatory and quality expectations. For example, you can include a reconciliation step when more translators collaboratively translate a document to give them the opportunity to discuss the differences and produce a final reconciled where two or more independent forward translations are merged into one single translation. Additionally, a back-translation and a back-translation analysis validation stepwould ensure the validity of the content in the target language. You can add comments to specific translated segments and notify your collaborator by email collaborators instantly directly from the interface of the Translation Editor.

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User Activity Audit Trail

The advanced Reporting reporting functionality embedded in Wordbee TMS allows you to mitigate the risk at every step in the project. You can trace the rationale for all translation and cultural adaptation decisions throughout the linguistic validation process by generating translation workflow reports directly from the Translation Editor interface. All the revision changes, every translation error, query and comment are recorded in the report together with the user’s details and the timestamp. The reports are customizable and ready to be send sent out to your end-customers or sponsoring companies.

Terminology Management