A UK-based contract research organisation (CRO) asked us to provide translation services for a phase III, randomised, double blind, placebo-controlled multi-centre trial.
Phase III studies test a new drug in comparison to the current standard, or in comparison to a placebo. During this trial, the patients are divided at random into two groups, one receiving the trial drug, and the other receiving a placebo. The term ‘double blind’ means that neither the trial subject (the patient) nor the treating doctor knows to which group the subject has been assigned.
The trial enrolled large numbers of people and was conducted at many doctors’ clinics and hospitals across Europe and Asia. After extensive testing, we were commissioned to provide the translation work for the duration of the trial. This involved:
Translating from English into various European and Asian languages for documentation such as protocols, patient information leaflets, patient informed consent forms, correspondence, along with reports, such as case report forms, serious adverse event forms and discharge summaries
Guaranteed one-hour response times with correspondence and reports
Providing an online weekly reporting system
We assigned a dedicated project manager with a specific background in medical trials, and who was familiar with the industry and requirements of bodies such as the EMEA
The project manager set up a team of qualified and approved translators, using our secure online forum facilities to share glossaries and reference material with this geographically dispersed team
We worked in partnership with our contacts at the CRO to finetune all wording, providing back translations into English to allow the client to assess the accuracy of the translation
All work was managed securely online to enable the client to manage the project easily and effectively
Translation results were to the satisfaction of the client both in terms of accuracy and delivery