DTS CASE STUDY

e‐Clinical Technology Company Needed Electronic Consent Forms Translated

The Problem


A technology services company contacted DTS in need of electronic mobile study translations from English to Spanish and French. Although the company had tried out previous translators, those translators did not possess the necessary experience and working knowledge of electronic consent forms and how to work directly with software files and mobile technologies. The company also needed help and advisement on best practices for non‐English speaking patients in using e‐Consent Forms, and steps which would minimize costly errors and delays in releasing them.

Their translation challenges included the following:

  • E‐File Sharing Advisement: How could they share large‐sized files while observing NDA requirements?
  • Translation Reviews: How to incorporate prior to the mobile consent software being finalized?
  • Scheduling: What timelines would be committed to? What about contingency scenarios?
  • Budgeting: How much would the e‐translations cost? How long would it take to receive proposals?
  • Project Changes: How easily could unexpected changes and deviations be managed during the e‐study?
  • Quality Control: Assurance of proper accuracy, quality and QA standards of the e‐translations?
  • Version Control: How could future English changes to the mobile applications easily and swiftly be
    applied to the foreign language versions?
  • Future Document Access: How could the e‐translations and electronic Translation Certificates be
    securely accessed in the future if needed, 24/7?

Solution Approach


DTS organized several conference calls to quickly outline a series of action steps. We listened to the developers, the regulatory management, and the finance professionals and outlined a direct plan that met their wants and needs, from cost‐approval to QA steps to Certification.

DTS staff with expertise and training in software localization were directly involved in managing the translation process. This created a direct,streamlined process, with DTS translators having immediate access to with our software specialists and when necessary, our client’s specialists.  Working as a team, the e‐consent form process went smoothly and all languages were compiled into their native formats over the course of multiple projects.

DTS also provided guidelines to our client regarding final QA validation of the e‐consents before they were released and used by patients in the study. This avoided potential costly errors, delays and invalidation scenarios caused by flawed processes experienced by patients in the study.

DTS staff then performed simple, methodical post‐mortem follow‐up steps to help ensure continued smoothness for future e‐consent translation needs.

Outcome


The French and Spanish e‐consents were compiled, validated and released on time and on budget in the study.  Similar translation projects of different mobile applications were then carried out over time with similar results—on budget and NO DELAYS.   

The translations and Translation Certificates were made available in the encrypted DTS Online Portal with controlled access. In addition, all translations were warehoused in language data bases engineered by DTS, in order to allow future e‐document version control to happen smoothly and cost‐efficiently.

Industries we serve


 
Life Sciences & Medical


 
Technical & Manufacturing


 
Financial & Legal


 
Technology

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