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 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 completed, you can automatically run a Quality Assurance (QA) job to check for translation or formatting errors. When a project is completed, the status of the project will automatically be set to “Completed”. All 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.

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 step would ensure the validity of the content in the target language. You can add comments to specific translated segments and notify your collaborator by email directly from the interface of the Translation Editor.

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 Management and Quality Assurance

Wordbee offers a web-based collaborative interface for creation and management of specialized glossaries. You can create multilingual concept-oriented termbases following the ISO standards for terminology management. All the terms, their variants, synonyms and target-language equivalents designating a single concept are stored in a single terminological entry. After you havce created your terminology database, add it to your project to ensure that your virtual team of linguists use the terms and phrases regulated in local markets and translate them consistently across all projects. To check whether the liguists have actually used the terms in the database, you can run an automatic QA Terminology check.

Technical Specifications

Platform independent

Microsoft Azure Security Compliance

About the Company

Wordbee is a cloud-based translation management system that you can customize to meet the needs of Life Sciences industry. As an end-to-end system it can be used to manage complex multilingual projects with real-time collaboration, automation, and high security standards.

Copyright information

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