Pharmacological and clinical trial translations
A classic technical translation exercise.
Client: Clinuvel Pharmaceuticals Limited
Background
Clinuvel Pharmaceuticals Limited sought our services for an extended series of translation surrounding clinical trial documentation and representation to several countries. An innovative Australian pharmaceutical company, Clinuvel manufactures a product that combats various pathologies in human beings that arise from over-exposure to sunlight. This includes various cancers and carcinomas as well as dermatological effects. As an Australian invention, the product needs to be registered by a number of national drug administrations in order to be sold in those countries. Registration for several European and Asian countries has been sought, and central to this is presenting results from Clinuvel clinical trails and the extensive documentation this involves.
Tasks and challenges
Submissions made to national drug administrations must be made in that respective language, necessitating translations for each national instance. Moreover, different demands are encountered from various national drug administrations, or from the same administration over time, so documentation needs to be constantly changed and monitored, and record keeping extending over several thousands of pages of documentation must be precise, both for authors and for translators, demanding attentive project management.
The voluminous correspondence back from the national drug administrations comes also in the language of that country, requiring translations again to convey approvals, detailed objections, scientific queries and general correspondence, which are then replied to again in similar detail in translated documentation. Developers at Clinuvel are thus dependent upon translations of equal fidelity in both directions with each drug’s administration.
For translators specifically, particular attention must be paid to the language of clinical trials: it is highly cryptic, uses a mixture of natural language and technical field-specific jargon, freely uses discipline-specific acronyms, and mixes pharmacological, procedural and legalistic language:
- ‘For the non-clinical evaluation of the potential for delayed ventricular repolarization (QT internal prolongation) by human pharmaceuticals, tests are to be carried out in in vitro and in vivo_ ‘
- ‘Providing AUC and t1/2 values as well as release rates in addition to Cmax _’
- ‘According to section 9, paragraph 2, sentence 2 of the GCP_V, the sponsor may change his/her application a single time within a maximum period of 90 days after receipt of this notification’.
Our methodology in handling this material was to use a translator-checker team for each translation, with team members drawn from professionally accredited translators with previous translation expertise in pharmacology or professional involvement in the pharmacology industry.
Achievement
For over 40 substantial translations extending over two years, there were no instances of feedback of complaint on quality of translation, or difficulties in relation to any linguistic aspect. Clinuvel has been successful in obtaining registration with several national drug administrations to date, with more pending.
We see such technical translations as having far wider ramifications than simply having one satisfied client. They show also to what extent Australian exporting companies are becoming increasingly reliant upon translation to get their products into world markets. Compared to the huge developmental costs of putting new drugs on the market, translation may be only a very small fraction of expenditure, However, without that translation then in this pharmacological instance a company will not be able to market its product at all in non-English speaking countries. The same would hold true for companies anywhere in the world wishing to enter markets with regulatory or procedural systems conducted in other languages, for which we can equally cater.
Translations were produced in the following combinations: English into Finnish, English into German, English into French, English into Dutch, and English into Italian.
Meaningful Exchange Translator qualifications
All translators of each language team have a minimum 5 years experience as a professional translator and have NAATI professional accreditation.
Australia has a system of national accreditation for Translators and Interpreters administered by the National Accreditation Authority for Translators and Interpreters [NAATI].
For further information about this project:
Contact: Ismail Akinci, CEO
Phone:1300 854 799
International Phone:+61 (3) 9605 3033
Email: Ismail.akinci@meaningfulexchange.com.au
