Clinical Trials
Clinical trial translations – precision that matters
Clinical trials are the foundation of progress in medicine. Every new medicine, therapy or technology must first undergo a complex research process. This requires precise and above all compliant translation of documentation. High-quality clinical trial translation largely depends on understanding both the research process and its regulatory requirements. There are many specific procedures and legal standards that must be considered when translating content such as trial protocols, patient consent forms or reports. Every word must be translated accurately, leaving no room for interpretation. At Omero Language Solutions we fully understand how important precision is. Clinical trial translations carried out in accordance with international norms and standards guarantee that your research documentation will be clear and accepted worldwide.
Sample documents requiring translation
- Informed consent forms
- Questionnaires
- Trial audits
- Audit certificates and reports
- Case report forms
- Clinical trial reports
- Clinical trial agreements
- Periodic reports
- Adverse event reports
- Trial monitoring plans
- Trial monitoring reports
- Study protocols
- GDPR documentation
- Marketing and HR content
- Patient diaries
Specialist terminology – the key to accuracy
In clinical trial translations maintaining precise terminology is crucial. Every document, from patient consent forms to trial protocols and reports, requires great care in translating specialist terms. Even the smallest inaccuracy can lead to misunderstandings that may compromise patient safety or delay the trial. We use terminology recognised by industry standards and translation memories that help us maintain linguistic consistency throughout the text. Working with medical experts we translate every trial to preserve meaning and intent. Our experience in translating documents for the pharmaceutical sector gives you an opportunity for international growth and efficient registration of new therapies.
The process of cultural adaptation includes:
Regulatory requirements and international standards
Our translators combine interdisciplinary medical knowledge with familiarity with Good Clinical Practice (GCP). We ensure that every text is terminologically precise and clear to patients.
With multi-stage quality control and review by native speakers of the target language we guarantee the highest service standards. Each translation can be certified with a Certification of Translation Accuracy (CTA).
Do you need translations for your industry?
Clinical trials are conducted worldwide, which means that to be recognised internationally documentation must comply with different regulations and standards. Each country where research takes place has its own rules concerning patient consent, research ethics, result reporting and many other aspects. This makes clinical trial translation a task requiring both linguistic accuracy and strict regulatory compliance. At Omero Language Solutions we ensure that our translations meet all necessary requirements, whether the trial is conducted in Europe and the EU (EMA), the United States (FDA) or Asia (PMDA in Japan, NMPA in China, CDSCO in India).
Clinical trial translations – accurate and on time
In clinical trials time is of the essence – any delay in translating documents can disrupt the schedule of the entire project. This may postpone the completion date or even delay the introduction of a new medicine to the market. We are aware of this, which is why we also provide express translations, minimising turnaround times without compromising on quality. We use modern technologies such as TMS systems and advanced text-editing tools that accelerate the translation of large volumes of documents while ensuring the highest precision. Every project is treated as a priority. Thanks to cooperation with experts who are well acquainted with the industry, our clinical trial translations are fast, accurate and compliant with regulations. This means fewer errors, complete clarity and no delays.