Ethical Considerations when Choosing Translation Service Provider for Clinical Trial Translations

Clinical trials are at the forefront of global healthcare research. They bring together researchers and participants from various continents to explore innovative disease prevention, detection, and treatment approaches. These trials, whether involving new medications, surgical techniques, or novel applications of existing therapies, hold the transformative potential to significantly improve the lives of millions.

Given the international scope of many trials, effective clinical trial translators have become indispensable. It is they who bridge language barriers among participants and researchers, ensuring clear communication and accurate understanding of protocols and informed consent procedures across diverse linguistic and cultural backgrounds. Their role is crucial in upholding ethical standards and regulatory compliance throughout the trial process.

Importance of IRB standards

When selecting a translation service provider for clinical trial translations, you must choose one who clearly understands Institutional Review Board (IRB) standards. These standards are fundamental pillars in the ethical conduct of clinical trials worldwide. IRB guidelines ensure that trials are conducted with integrity, safeguarding the confidentiality and rights of participants at every stage of the clinical trial process. This includes rigorous protocols for obtaining informed consent, ensuring participants fully understand the risks and benefits involved, and protecting their privacy throughout the study.

A translation service provider familiar with IRB standards plays a crucial role in upholding these ethical considerations. They must accurately translate complex medical and legal terminology into participants’ languages while preserving the original intent and ensuring clarity. This requires not only linguistic proficiency but also a deep understanding of the sensitive nature of clinical trial documentation.

The Role of ISO Certification

ISO certification is another critical aspect that cannot be ignored when evaluating a translation service provider for clinical trial translations. ISO standards ensure the provider follows rigorous quality management practices crucial for maintaining accuracy and reliability in clinical trial documentation. Specifically, ISO certifications such as ISO 17100 for translation services are highly relevant in this context.

ISO 17100 certification specifically focuses on translation services and sets forth requirements for the core processes, resources, and other aspects necessary to deliver a quality translation product. This standard encompasses criteria for translator qualifications, translation process management, and quality assurance measures; all of which are essential for ensuring the accuracy and consistency of translations in clinical trials. By selecting a provider with ISO 17100 certification, researchers can have confidence that the translations meet stringent international benchmarks for linguistic accuracy and technical precision.

Why DTS is the right translation provider for your clinical trials

At DTS Language Services, clinical trial translations are not just a service we offer, they are our specialty. With over 50 years of experience as an ISO-certified Language Services Provider, we are committed to delivering high-quality certified translations. We understand the time-sensitive nature of clinical trials, which is why we offer guaranteed turnaround times and dedicated project management to ensure your translations are delivered on time and to your satisfaction.

Over the decades, we have not just worked, but collaborated closely with clinical research organizations (CROs), pharmaceutical companies, and medical device manufacturers. Our deep understanding of the complexities involved in clinical trials, coupled with our expertise in translating trial documentation for the IRB and regulatory approvals instills confidence in our clients.

Our ISO 17100 certification is not just a badge, it’s a testament to our unwavering commitment to quality and precision in translation services. This internationally recognized standard sets rigorous criteria for translation service providers, and our adherence to it reinforces our excellence in every aspect of the translation process. With DTS, you can be confident that your translations meet stringent international benchmarks for linguistic accuracy and technical precision.