Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to participate in clinical trials to test medical interventions including medicines, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, and preventive care.
Clinical trials are designed, reviewed, and completed with precision, and need to be authorised before they can begin. People of all ages can take part in clinical trials, including children.
Phase 1: test new medicines for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
Phase 2: test treatments that have been classified as safe in phase 1, but now requires a larger group of participants to monitor for any adverse effects.
Phase 3: studies are conducted on larger populations and in different regions and countries and are usually the last step before a new treatment is approved.
Phase 4: studies occur after country approval and there is a requirement for further testing in a wide population over a longer timeframe.
As the phases specify, clinical trials will regularly involve multicultural groups speaking different languages. Proper documentation and translation of each step are required, which includes total consent and full understanding of the participants. All statistics show that there are still frequent language barriers that must be overcome in the clinical trial industry.
Clinical trials are required to reduce global disease burdens by helping to develop safe and effective new therapies and vaccines. These solutions may be for non-communicable diseases such as cancer and diabetes, or infectious diseases in Africa. Developing countries are under-represented in research due to a lack of commercial viability and trained researchers, yet it is in these poorest regions where research-led solutions could bring the greatest impact to high rates of early mortality.
Clinical trial data are often accumulated from varied populations because geographically different trial sites are vital to ensure the product is safe and works in the same way in varying ethnic groups. Clinical trials are also expensive and are taking longer to conduct than in the past, thus further compounding the increased costs, and this is the case for all types of trial, whether commercial or academic. Therefore, clinical trials are being conducted across more diverse countries for economic reasons.
There are various justifiable reasons for conducting clinical trials across multiple countries and continents, or even only in sites that are not in the sponsor's location. Some countries can recruit participants faster than others for diverse and valid reasons.
One of the first documents that requires a translation service company is the patient consent form translation. Participants sign a document stating that they agree to participate and that they have been given enough information to make an informed decision. Another important document is the patient questionnaire translation, which discloses important information about their medical history. Any misunderstanding could lead to additional complications that would not only undermine the trial outcomes but could also have undesired consequences for their health.
Biomedica Translations ensures diversity and inclusion in addition to improving the medical solutions available, by providing high-quality clinical trial translation services to patients, researchers, and other key stakeholders. Translation services for clinical trials should be provided at each stage, to ensure consistency and coherence. Our team of native subject-matter experts can translate all clinical trial projects and deliver a technically accurate translation.
Clinical research organisations worldwide require the services of an experienced clinical trials translation company when translating important documents. Biomedica Translations provides high-quality clinical trials translations in more than 100 languages, and our subject-matter experts are experienced in various life science translation fields, including biotechnology industry translations, clinical trial translation services and biotech translation services. Our team of clinical trial translators regularly provide their clinical trial translation service expertise to pharmaceutical companies and medical device manufacturers, ensuring that nothing is lost in translation.
