thebigword’s Life Sciences division:
Multilingual clinical trials
A complex challenge
Over the past decade, clinical trials have become more globalised, complex and specific. thebigword’s Life Sciences division have extensive experience of multilingual clinical trials, having partnered successfully with one of the world’s leading CTOs (Clinical Technology Organisations) over the last four years to support over 1,000 trials across over 70 languages. The CTO provides automatic randomisation and logistic management of clinical trials using IVR & IWR, and are one of the market leaders in ePRO. We also work directly for pharmaceutical companies such as Wyeth and Chugai.
IVR and ePRO: specific considerations
We have become the leading localisation services company to handle the translation of IVR prompts, recognising the complexity imposed by specific sentence structure and the need for consistency between local-language documentation and the prompts; for ePRO, meanwhile, as the outcome depends on patient data, it is critical how the question is asked and answered in the patient’s language, ensuring the patient has a clear understanding of their participation.
thebigword’s unique approach
At thebigword we have responded to these challenges by using our LanguageDirector™ technology and specifically designed workflows and quality processes – with stage-by-stage sign-off – backed up by translators selected for their particular expertise in the clinical field. All personnel involved in these studies have undergone a thorough documented training programme, developed in conjunction with our Clinical Services Specialist, who came to thebigword from a CTO background. This allows us to provide the highest quality of translation, compliant with pharmaceutical industry regulations, and enabling a full audit trail.
How we can help
We believe that your organisation will benefit from the experience of thebigword’s Life Sciences division, enabling you to improve the quality of your multilingual clinical trials and to avoid the serious risks of non-compliant or non-auditable localisation processes.
Robert Timms, Strategic Accounts Director
Tel: +44 (0)20 7012 6294
Email: robert.timms@thebigword.com
Maureen Smith, Clinical Services Specialist
Tel: +44 (0)7814 527 184
Email: maureen.smith@thebigword.com