Translation services for a phase III multi-centre trial

A Contract Research Organisation based in the UK requested APT 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 GP’s clinics and hospitals across Europe and Asia. The precise wording of the documents relating to clinical trials is crucial and the English originals tend to go through several rounds of writing and rewriting, and APT makes sure that the translation team takes the same care when localising the documentation.

After extensive testing with our company, we were commissioned to provide the translation work for the duration of this phase III clinical trial.

Brief

Provide translation from English into various European and Asian languages for documentation including Protocols, Patient Information Leaflets, Patient Informed Consent Forms, Correspondence and reports such as Case Report Forms, Serious Adverse Event Forms and Discharge Summaries
Guarantee 1-hour response time with correspondence and reports
Provide an online weekly reporting system

Solution

APT provided a project manager with medical trials translation background and experience, who is familiar with the industry and with requirements of bodies such as the EMEA
The project manager set up a team of qualified and approved translators, and used our secure online forum facilities to share glossaries and reference material with this team
Work alongside our contacts at the CRO to fine-tune the 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

Result

Translation results were to the satisfaction of the client both in terms of accuracy and delivery

Next Phase

As a direct result of the quality of the work we produced, we have been asked by the pharmaceutical company to produce all subsequent translation and localisation work for the new drug, including the Summary of Product Characteristics and labels.

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