Translations for clinical research
What is the role of translation in the field of clinical research?
One molecule in 10,000 reaches the market from a process that begins by identifying a pharmacological target and then discovering substances that can bind to this target in a specific and selective way (lead compounds). The whole process lasts from 10 to 15 years.
Clinical research is the most crucial phase of drug development, during which the selected molecule must demonstrate its safety and efficacy in humans.
For a clinical trial to be initiated, it has to receive authorisation from the competent regulatory authorities (the Italian Medicines Agency [AIFA] in Italy). Then it must obtain a favourable opinion from the competent Ethics Committee of the investigational trial site. This opinion is based on an evaluation carried out from an ethical, scientific and methodological point of view.
Certain documents in the local language must be submitted with the application for authorisation.
Which documents are translated?
Translators specialising in clinical trials work on a wide range of documents which are very different in nature, structure, register and style: protocol synopses, patient information sheets and informed consent forms, information sheets for personal data processing, GP letters, patient cards, case report forms, and patient diaries, where required.
It is also necessary to translate the clinical trial agreements drawn up between hospitals and the clinical trial sponsor and/or the CRO appointed by the sponsor, and any other specific consent forms (e.g. consent for optional genetic testing and for the pregnant partner, assent for minors, consent for any sub-studies, etc.) or information documents or instructions for research participants.
The importance of continuing professional development
Why is CPD so important for translators specialising in the field of drug development and clinical research?
The answer is simple and can be summarised in one word: innovation.
Innovation is an important element in all fields, but it is absolutely essential in the field of clinical trials.
Innovation naturally brings important benefits but also poses serious challenges since it demands continuous flexibility from our governance systems, from regulations and from all stakeholders involved.
The same flexibility is required of the translator, who must keep up with this constantly changing situation.
And this is only possible through CPD and, more specifically, by participating in workshops, seminars and conferences to keep up to date with any important changes that are taking place now or that may take place in the future.
The importance of ONLY translating what you know
In fields such as medicine and clinical trials, one single word can make all the difference.
PharmaTrad is aware of the regulatory implications arising from the choice of one term over another.
This is why we make constant and careful reference to official resources such as MedDRA, the EDQM Standard Terms, and the WHO’s International Classification of Diseases (ICD), as well as official documentation from the EMA, Italian Medicines Agency (AIFA) and other institutions.
And, last but not least, we keep a close working relationship with our clients, ensuring a fruitful exchange of expertise and experience, and efficient problem solving.
This is why we don’t consider ourselves simply a service provider but rather a partner – someone to help you achieve your most important objectives!