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 (CTA), Informed Consent Forms (ICFs), Patient Reported Outcomes (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 Wordbee you can automate your processes based on pre-defined workflow templates to minimize the risk of human errors and decrease turnaround times and costs. Automation improves collaboration of your virtual teams, leading to increased productivity, consistency and quality.

Translation and Linguistic Validation Workflow

Create standardized linguistic validation workflows according to best COAs translation practices to ensure 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 translation. Additionally, a back-translation and a back-translation analysis stepwould ensure the validity of the content in the target language. All the comments and changes made by the linguists can be exported You can add comments to specific translated segments and notify your collaborator by email directly from the Wordbee interface of the Translation Editor.

Image RemovedImage Added

User Activity Audit Trail

The advanced 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 to your end-customers or sponsoring companies

Terminology