Package Insert 35
Interesting facts and figures for customers and partners of mt-g.
October 2015
mt-g's fields of expertise
Clinical Studies
How effective is a new treatment or medicine? What is the picture regarding safety? What are the possible side effects? Clinical studies answer these questions. The purpose is to test the effectiveness and tolerability of new medicines or interactions with other medications in several phases in humans before they are launched onto the market. These studies require detailed documentation as well as comprehensive information for the patients. mt-g's Clinical Studies Team specialises in precisely these challenges facing the contract research organisations and pharmaceutical companies involved. By means of professional translations, back translations, adaptations and reviews, Giulietta Toneatto's team ensures that everything runs smoothly in all study phases.
In an interview, Giulietta Toneatto, Team Leader Clinical Studies, gives an insight into the specifics of her job.

The Clinical Studies Team (from left to right): Selma Hadziefendic, Julia Kratz, Giulietta Toneatto, Julia Bosch
Package Insert: What's distinctive about the texts and documents for translation in the clinical studies field of expertise?

Giulietta Toneatto: What typifies these documents is that a distinction is made between medical texts on the one hand and patient information sheets – known as ‘patient-facing documents’ – on the other. Synopses and SAE reports rely very heavily on the translator's background medical knowledge. With patient-facing documents, it is hugely important for all the information on the study procedures to read fluently and be easy to understand.

Package Insert: To what extent do the requirements for translations in the clinical studies field of expertise differ from those in other fields?

Giulietta Toneatto: The translations we handle often have to be ready within a very short time and by a specific deadline – depending on when the study has to be submitted to the relevant ethics committee. This means that everyone involved works under extreme time pressure.

Package Insert:
What special expertise do project managers and translators have to possess to work on the translation of clinical studies every day?

Giulietta Toneatto: Besides the technical knowledge they possess, the project managers within the team all excel at being extremely resilient even when under great time pressure. The translators bring a high level of flexibility in relation to the translation deadlines. A translation will often be completed on the weekend in order to meet the submission deadline. In addition, overlapping specialised requirements in global regulatory affairs frequently have to be taken into consideration. For example, the project managers have to be able to recognise when an EDQM Standard Term or MedDRA terminology occurs in a text.

Package Insert: As team leader, what is especially important to you?

Giulietta Toneatto: I attach the most importance to the team members being able to work as a team and especially to a high level of resilience. Particularly when it comes to urgent projects – and there are often several of them a day –, project managers have to be able to concentrate on the work and not allow themselves to be ruffled.More information
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