The term “clinical trials” refers to research that relies on the use of living human participants to determine the effectiveness of medicines, medical treatments, and medical devices. After a medicine or other medical aid has been found through laboratory trials to be safe enough for use on people, clinical trials are set up to determine how well it works.
These studies take place in phases, usually using groups of adult individuals from various segments of the population (young and old, male and female, representatives of various ethnic groups, etc.).
What are the most important things to remember during the course of clinical trials (CT) translation projects?
Since clinical trials report precise data regarding side effects, success rates, dosages, testing procedures, etc., it is essential that the translations contain accurate, consistent terminology and texts that can be clearly understood by all participants in the process. Maintaining data confidentiality is also crucial.
Are there any distinctive features of clinical trial translations that other translation projects don’t have?
First of all, there is a wide range of documents required (e.g. patient information, documentation for clinicians and research administrators, regulatory and legal documents). Therefore it is vitally important to carefully analyse all parts of the translation project in order to determine the specialization and intended purpose of each part.
Secondly, LSPs handling CT translation projects have to ensure that the translations follow all the local requirements for clinical trial texts. The EU, for example, has recently introduced stricter translation standards for all documentation and communication regarding medical devices (including mHealth apps) in its new Medical Device Regulations (EU MDR). Clinical trial translations for new medical devices will also fall under its jurisdiction. Our CT translators for EU documents must be clear on relevant regulations and standards as well as CT terminology.
Can you describe the main stages of a typical CT translation project?
Skrivanek treats every translation project with the greatest care, taking a number of standardised steps from the initial receipt of files to their eventual completion and delivery to the client. Thorough attention to each step becomes especially important in scientific fields like clinical trials.
1. Source text analysis
Our project managers check for content, style, and complexity of the source text in order to assign it to the most appropriate translation team and to provide them with relevant reference materials (terminology glossary, style guide) which help maintain the accuracy and consistency of specialised terminology.
The translation is performed by a native speaker of the target language who is an experienced translator and specialist in the medical field, and well acquainted with international regulations and standards. All our professional translation services are processed in adherence to the standards of the ISO 17100 and ISO 9001 certifications we hold.
In addition, the translation process includes several steps of further quality control:
Once the translation is completed, the editor/reviewer – a second independent linguist, who is also a specialist in the field – compares the source and target documents to check that the translation accurately reflects the intended meaning, content, and terminology.
4. Quality Control/Proofreading
Once the editing/review phase is completed, another native speaker of the target language checks the translated text and focuses on the syntax, grammar, style, potential typing errors and formatting. They use various QA tools that are remarkably helpful and have a number of features which facilitate the production of superior translations.
5. In-house Check
Before the delivery of the translation, the Project Manager makes sure that all steps of the workflow have been completed in compliance with the client’s instructions.
6+ Additional Services
In the case of large-scale orders, more linguists might be involved and additional steps included so that all the translators and reviewers/proofreaders can share a single terminological database to maintain uniform terminology throughout the entire text. A project may also include other additional services, such as DTP processing and subsequent pre-print proofreading if required.
How important is close communication with the client during these projects?
Communication with the client is extremely important and project coordination can save time and costs. For example, Project Managers sometimes need to get approval from the client about content that should be kept in the original source language (e.g. company or product names, abbreviations), or they need to resolve other queries related to terminology or style.
How do you select linguists for CT jobs?
We take extreme care in selecting our suppliers; we can ensure that only highly qualified and professional linguists with numerous years of experience are involved with our clinical trials translations. All of our translators and reviewers/proofreaders are tested before we start cooperating with them and even after that their performance is further monitored and evaluated on a regular basis. This way we can also provide them with regular feedback about details of the jobs they are working on.
Does the PM need to be a medical expert?
PMs don’t need to be medical experts to oversee clinical trials projects but they need to familiarise themselves with all the project details so that they can choose the best workflow based on the project specialisation and its purpose. This way they can put together the most suitable team of translators/reviewers.
What advice would you give to a potential client looking for an LSP for their CT project?
Potential CT translation clients should bear in mind that clinical trial translation is demanding and requires extensive, specific areas of specialization and experience. When looking for a language service provider for this type of job it’s important to verify that the LSP with whom they choose to cooperate is accustomed to meeting the client’s requested standards, which may include local legal requirements. CT jobs require an especially high level of consistent professionalism. At Skrivanek, we consider all parts of the translation process to be equally important:
- selection of which employees we involve in these highly specialised projects
- appointing the right linguists
- determining the appropriate workflow
- analysing the source text and the target purpose of the project
- using the latest technology to ensure the terminology consistency.
It is also advantageous for the client to find an LSP that can handle all the languages and phases of the translation project – this reduces the chance of errors, inconsistencies, and delays. And for ongoing CT projects this overseeing LSP can guarantee centralised storage of all the client’s translations and call them into use when subject matter is repeated in other phases. This type of centralized use of translation technology reduces costs and ensures the highest possible quality of the translation.
J. V. McShulskis