ClinPhone Case Study

thebigword - harnessing technology to deliver an integrated translation solution that enables global clinical trials

Background

ClinPhone is a leading Contract Technology Organization (CTO) offering a unique combination of internet and telecoms technology to enable clinical trials on a global scale. ClinPhone are also recognised as the market leader in ePRO (electronic patient reported outcome) studies and their offering of e-solutions are used by the world's leading pharmaceutical and biotechnology firms. With offices across Europe and North America, the global reach of ClinPhone's offering presents a unique combination of translation challenges. Before a study can go-live, user documentation needs to be sent to all study participants in the local language. When the study reaches go-live, study participants dial-into ClinPhone's bespoke IVR system to report trial activity, a process which is enabled by voice prompts in the local language.

Trials are conducted in many countries simultaneously, so content needs to be translated into many languages whilst meeting demanding schedules and adhering to rigorous quality control procedures. thebigword has been meeting this need since 2003.

The Challenge

ClinPhone's unique combination of technology demands translation of 2 content types:

• high-quality user documentation which is distributed to all study participants.
• the IVR prompt content which is translated, recorded and uploaded into ClinPhone's bespoke CMS.

Timelines are demanding and quality is paramount. Consistency is required across user documentation and IVR prompts, both within and across studies. ClinPhone's clinical project managers, located in North America and Europe, need easy access to a translation service that will meet these time and quality goals. Furthermore, a fully-integrated workflow is required to enable export of XML content from ClinPhone's bespoke CMS for translation. Study budgets are tightly controlled, so the translation service needs to take full advantage of technology to keep costs under-control.

The unique requirements of the ePRO studies present further challenges. The specifications of the ePRO workflow require translation, back-translation, quality reconciliation and clinical review, with full quality control and sign-off at each stage.

The Solution

Technology is key to thebigword's solution. Translation Memory ensures consistency across content from all translation users within ClinPhone, and it's essential to maintain quality within the extensive translation teams required to meet translation volumes. LanguageDirector™ allows ClinPhone's clinical project managers across Europe and North America to request translation of clinical trial documentation in a consistent method via a secure, web portal, and thebigword is able to integrate with ClinPhone's bespoke CMS using the web services API component of LanguageDirector™ enables a seamless workflow for translation and delivery of IVR prompt content in XML format. The application of translation technology is backed up by robust project processes designed to fulfil the regulatory requirements of the pharmaceutical industry. thebigword has developed and approved a QA process jointly with ClinPhone to ensure the specific translation quality standards for clinical trials can be achieved and the challenges posed by the ePRO process have been met by a bespoke workflow for ePRO projects. This workflow, developed jointly by thebigword and ClinPhone, includes full sign-off and independent checks at each stage.

The Benefits

thebigword's complete solution for ClinPhone blends powerful technology with robust, bespoke processes that streamline the entire translation process. The benefits of translation memory extend further than quality; costs are dramatically reduced by removing the need to re-translate content. thebigword constantly reviews its offering and workflow for ClinPhone, ensuring that the most efficient and robust service is in place.