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 should therefore be fairly obvious why translating clinical trials documentation is so important – any messages, documents or materials need to be made available in their native language.
Previous Clinical Trials Translation Projects
At Comms Multilingual, we are involved across many stages of the clinical trials translation process.
Among the many documents involved in bringing new drugs to market, the following is a selection of some of the translations of clinical trials materials that we have produced:
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)
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 in materials used for clinical trials require translation and localisation 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 during the concept mapping and translatability analysis.
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.
It is important to ensure that the translation of clinical trials materials is a correct reflection of the original, yet also reads well in the target language.
Life Sciences Translation Processes
Given the critical role that language plays in the process of bringing a drug to market, and the importance of conveying information at the right level and to the right people, we offer industry-standard processes which provide multiple opportunities for review, discussion and amendment of the translation throughout the process.
Linguistic Validation of Clinical Trials Translations
Typically, our clients will follow a best practice linguistic validation process when translating clinical trials materials. The services we often provide for such a project include:
- Concept sheet (pre-translation analysis and definition of terms and concepts)
- 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 the translation of an ICF or PIL.
Please contact us for a discussion about your particular clinical trial translation requirements, or complete the form below if you would like to request a quotation.
Clinical Trials Translation Case Study
Read here about how we helped one of our clients translate and validate their clinical trial in a number of languages.
Why Choose Comms for Clinical Trials Translations?
- We use accredited, professional and qualified translators who are native speakers, with numerous years of experience in clinical trial terminology.
- We understand the regulations and work together with our clients to achieve their aims – high-quality, defensible translations of clinical trials materials and conceptual equivalence.
- We are ISO 17100 certified and have a suite of tailored linguistic validation services to ensure that your clinical trials translations perform as expected.
- We know the requirements, procedures, processes and workflows involved in clinical trials translation projects, and can advise on best practice.