Translation of regulatory submissions is often perceived as a necessary evil by clinical trial management teams, because it involves considerable financial outlays. Therefore, persons responsible for regulatory submissions are usually under a lot of pressure. Despite serious efforts to ensure maximum consistency between submissions for different countries where international clinical research projects are carried out, differences are sometimes unavoidable because different detailed requirements are applicable for individual markets. What makes this process even more challenging are strict regulations governing the life science industry, which do not allow much flexibility in relation to documents being prepared.
Pharmaceutical companies wishing to expand further to new, potentially highly profitable regions of the world must bear in mind that translating documentation into local languages is a huge challenge alone and carries great risks. Despite efforts to standardise the requirements of regulatory agencies, processes and terminology on a global scale, there are still significant differences in all these areas between individual countries and regions. They cause difficulties in the process of translating product information and study documentation. An approach considered ideal for one country or region will not necessarily be appropriate for another and this is what makes translation of documents for regulatory agencies difficult and costly. Even minor but serious errors can delay the start of the study, slow down placing the product on the market, lead to a decision to withdraw it or, at worst, cause risks for patient safety. When a race starts to enter a new market, sponsors define very tight deadlines. As a result, certified translations of very long documents are often required within two or three months. A key milestone is therefore the development of a precise translation schedule so that regulatory submissions can be made within the agreed timeframe. When the aim of a drug manufacturer is to supply a new medicine to patients as quickly as possible, all that they want is to avoid stopping the procedures for their product because an effective plan to meet the requirements of local regulatory agencies is missing.
Until recent times, the most popular approach has been to delegate responsibility for regulatory activities to local teams, but such a strategy has not guaranteed identical standards for different regions in terms of quality, appearance or ease of comprehension of translated materials by the reader. There are 24 official languages in the European Union itself, while based on data compiled by Ethnologue linguists, more than 7,100 languages are spoken worldwide. When extending the project to farther regions, account should also be taken of locally used dialects, which means that materials for patients should be prepared in the relevant dialects in order to enable patients to understand the study in which they are to participate in detail.
In order to ensure the greatest possible consistency and, at the same time, efficiency (both when it comes to time and financial aspects) in the translation of documents for global clinical research, an increasing number of companies opt for a centralised approach. Working with a single provider specialising in life science translations has many advantages. Such translation providers cooperate with skilled and experienced professionals working in this field on a daily basis and have translation memories customized for each study sponsor. It is worth mentioning that individual pharmaceutical companies have their own specific terminology and document templates. When using the services of a single translation provider, such materials do not have to be made available to the translation company every single time a translation is ordered. If a translation has to be provided on a tight deadline, the said translation provider is able to speed up the process by using pre-approved glossaries and working with specialists who dealt with similar assignments in the past. That leads us to the conclusion that the longer the cooperation between a sponsor and a translation provider, the faster the translation provider is able to deliver the final product meeting the expected quality standards.
