TRANSLATION AND LOCALIZATION IN CLINICAL TRIALS TRANSLATION

We are living in a time of globalization of clinical trials, and the tendency is for them to occur in emerging countries. As such, translation and localization services are essential in the process stages, passing from the initial protocols to the final results. In view of the complexity involved in the trials and considering the safety and clinical validity, the processes have strict guidelines. The processes are standardized by international declarations for ethical practices, with many documents and analysis processes. Another important factor is approvals that ultimately take too long.

Clinical trials are usually developed in a particular country and then replicated in several clinical study centers in several countries. This is where translation companies come in. They play a fundamental role in the middle of the process, as they help establish communication between countries through the adaptation of documentation. This also influences how pharmaceutical companies interpret the results reported by participants (PROs).

Incorrect translation can lead to far-reaching consequences: it can endanger the lives, which are the most precious commodity, of the participants, negatively interfere with the profits of pharmaceutical companies, discredit the company, and cause financial losses.

What are the consequences of incorrectly executed translations?

1 – The participant may have difficulties in understanding the instructions for administering the drug, taking it incorrectly, or be unable able to understand the possible side effects, preventing them from identifying and reporting such.
2 – The participant may not be able to follow the process correctly, as they were unable to understand it.
3 – Because it has not been correctly located for the country of destination, the language may cause the test to be disapproved by the regulatory authorities of the country in question.
In more extreme cases, the test itself may not be performed properly, wasting resources, time and personnel.

What is the relevance of the target audience of the clinical trial documents?

Clinical trials are guided by several protocols that support communication between all involved. Each of the protocols describes methods, objects and organization of the essay. As a rule, these documents are formal and with technical language. The complexity of this technical language requires an objective and direct writing, not giving rise to ambiguities.
However, the target audience of these documents are not always the specialists and technical professionals related to the trials, and it is necessary to adapt them to other audiences. This is where well-executed and planned translation comes in.

Each reader of the clinical documentation has a different level of technical knowledge, differing between physicians, researchers and end users, therefore, there are appendices and additional information with instructions not so technical to standardize the understanding of the procedures.

We can exemplify by citing consent forms, which are documents that need to have clear, objective and adapted language for the understanding by individuals, whether they are experts or not. The documents record the conditions for being part of a clinical trial. Each participant participates by signing the document after being informed about the nature of the study and the associated pros and cons. It is for this reason that the final product of translations must be well done and include all the people who have contact with them.

It is the translator’s role to consider all these variants and adapt the language to the target audience. At Global Languages, our Translation team performs these analyses and weightings with excellence, always respecting the terminologies to be used.

Document Localization Process

Translating the protocols of clinical trials requires a full understanding of the object and purpose of the study, as it is necessary to provide a service that exceeds the limits of simple translations, focusing on the theme, the public and the purpose of the document.

In view of the complexity of the requested service, hiring qualified and specialized companies in the areas of Translation and Localization guarantees adequate and quality final results, as there will be regulatory, terminological and legal compliance, which Global Languages guarantees and reaffirms with its time in the market, successful projects and partnerships established over the years.

Ethical guidelines permeate the documentation and not complying with such implies serious consequences for the health of those involved, and may even lead to death. As such, translation and localization must be carefully conducted throughout the project, so that no information is outside the understanding of any of the target audiences.

We provide clients with teams of qualified specialists to assist in the elaboration of terminologies, whether in the health, business, commercial or industrial area, always being guided by the company’s identity and regulatory compliance.