The necessity of global coordination in clinical trials has particularly come into the spotlight during the past year as a result of the COVID-19 pandemic. While most clinical trials occur in a pharmaceutical’s country of origin, it is important to translate and localize the trials into other languages, so the data can be gathered, researched, and made available across borders.
COVID-19 and the Increased Demand for Clinical Trial Translation Services
Because of COVID-19 and the race to find a vaccine, there has been an increase in the need for clinical trial translation and localization services. With 650 groups across the globe conducting 460 coronavirus vaccination trials on people from various nationalities, the need for clear information, coordinated efforts, and precise translations has become even more transparent than in the past. As such, pharmaceutical companies and researchers are turning to clinical trial translation companies for support.
Localizing All Aspects of Clinical Trials
To ensure that a clinical trial is understandable to everyone involved, all facets of the trial should be localized. It is especially important to localize clinical trial protocols, which explain the trial’s objectives, methods, design, organization, and statistical aspects. Through localization, the protocol can be tailored to a region to prevent any ambiguity and to ensure that all documents are accurately, concisely, and clearly written in a way that resonates with participants in their languages.
Along with protocols, other clinical trial information that should be localized:
- Patient questionnaires that are used to determine a person’s eligibility for the trial.
- Adverse event reports to make potential participants aware of any side effects.
- Informed consent forms to make certain that all participants know key information that can help them decide whether to join the trial.
- Patient records to ensure that trial administrators are aware of any health concerns that would prevent someone from participating.
Advantages of Partnering with a Clinical Trials Translation Service
To ensure that your clinical trial translation and localization project is successful, partner with a language services provider (LSP). The advantages of working with an LSP include:
- Translating pharmaceutical and medical terminology with precision. Medical jargon that will be used in clinical trial documentation can be especially challenging to translate. Working with an LSP that has subject matter experts in the pharmaceutical and medical fields will guarantee that the medical translation in the trial documents is completely accurate.
- Focusing on cultural sensitivity. Being aware of cultural nuances is critical to ensuring that participants understand the trial, as well as making them feel comfortable throughout the process.
- Addressing any technical issues that could arise during the translation and localization process.
- Ensuring that the clinical trial translation is completed on time.
- Making certain that the localization addresses any revisions in functionality, information, research design, and any other necessary aspects in an efficient manner.
- Developing a translation memory database for future research and trials. This database would include translations, source documents, terminologies, and glossaries for subsequent use.
- Meeting extensive international standards and regulations.
How Ulatus Performs Clinical Trials Translation
At Ulatus, we understand the significance and value of clinical trial translation and localization, and we work with companies to stay within their budget and timeline. Our clinical trial translation process includes:
- Following a clinical trial translation methodology that is customized to company’s needs while taking into consideration regulatory requirements for the trial.
- Utilizing in-house technology that permits us to streamline content that is replicated and facilitates cost and time savings.
- Dedicating a project team that includes a team lead, subject matter experts, and translators who are native speakers of the source and target languages.
- Implementing an extensive quality management process to guarantee that every aspect of the clinical trial translation has been carefully addressed.
Among the worst potential outcomes of a poor clinical trial translation is a serious adverse event that threatens lives, as well as a costly delay that prevents a vaccine from getting distributed to the people who need it most. To ensure that these outcomes do not happen with your translation and localization, partner with a top-notch clinical trials translation company.
Summary
As a result of the COVID-19 pandemic, it has become increasingly clear that clinical trials have to be translated and localized to ensure that vaccination data is researched, gathered, and disseminated across borders.
