Clinical trials are a vital part in the long and involved process of bringing a new drug to market.
They may be carried out in one or in several different countries and may involve people whose native language is different from the language of their adopted country.
It is vital for these people to understand exactly what will be involved in such trials and what will be expected of them. It is thus very important that any messages, documents or materials are made available in their native language.
At Comms Multilingual, we have been involved in the translation, localisation and adaptation of documents for many different parts of the clinical trials processes.
Types of Document
Among the many documents required to bring new drugs to market, the following is a list of just some of the documentation that we translate in this area:
- Invitations to potential participants
- Patient information leaflets (PILs)
- Informed Consent Forms (ICFs)
- Appointment reminder cards
- Outcome data (PRO, ClinRO, ObsRO, etc.)
- Case Report Forms (CRF)
- Visit booklets
- Medical reports
Localisation and Adaptation
It is important to ensure that the translation is a correct reflection of the original, yet also reads well in the target language.
There are often elements in an original text which will need to be adapted and localised for the target market. For example, dates, number formats and weights and measures may need to be changed to match local customs.
At Comms Multilingual, our experts can provide localisation and adaptation advice and input. This step needs to be considered prior to the start of the translation process to ensure maximum effectiveness.
We provide our suggestions and our clients then review these to ensure that any such changes would not affect the validity of the document in the target language.
Life Sciences Translation Processes
The typical services we provide for such a project might include:
- Concept sheet (pre-translation analysis and definition of terms)
- Forward translation (single or dual)
- Proofreading (or reconciliation, as appropriate)
- Back translation
- Internal quality assurance checks
- Subject Matter Expert review
- Cognitive debriefing / pilot testing
- Multilingual desktop publishing / typesetting
The processes chosen for a particular document will usually vary according to its nature; for example an appointment reminder card may require a different level of attention to an ICF or PIL.
Please contact us for a discussion about your particular requirements in this area, or complete the form below if you would like to request a quotation.