Services
When it comes to translating the content in the medical or life science field, our services are certified according to international translation standard ISO 17100 and ISO 9001. Also, a dedicated life science translation team of project managers, subject matter experts, and linguistic quality assurance specialists, and compliance team will make sure to follow the strictest quality and compliance requirements.
At Hansem Global Life Sciences, we go above and beyond industry standards to deliver Clinical and Medical translations services of the highest quality. We proudly adhere to the ISO 17100 standard, ensuring that our processes meet rigorous requirements for translation service providers.
Additionally, we apply the ISPOR methodology, a recognized and trusted approach in the field of health economics and outcomes research, for linguistic validation services of PROs, COAs, and eCOAs. By following these standards and methodologies, we guarantee accurate, culturally sensitive, and reliable translations for our pharmaceutical, healthcare, and medical device clients. Partner with us today to experience the excellence that comes with our commitment to industry best practices.
Our team of experienced translators possesses in-depth knowledge of the Life Science and Medical Device industries, enabling us to tackle complex terminology, technical content, and scientific concepts with utmost proficiency. In addition, we would like to ensure that your translations are linguistically accurate while maintaining the integrity of the subject matter.
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Our Translators specialize in translating essential clinical trial documents, ensuring accuracy and precision in protocols, informed consent forms, case report forms, and study reports. Our team of experienced translators with expertise in life sciences ensures that all parties involved, including sponsors, investigators, and patients, have a clear understanding of the trial procedures and requirements.
Regulatory Compliance
Regulatory compliance is vital in the life science industry. Hansem Global offers expert translation services for regulatory documents, including IND applications, NDAs, CTDs, and regulatory correspondence. Our translators have a deep understanding of regulatory requirements, ensuring that your documents comply with local and international regulations. We help facilitate successful regulatory submissions and approvals, enabling you to navigate the complex regulatory landscape with confidence.
Patient Recruitment Material:
We understand the importance of effective communication with potential study participants. We provide expert translation services for patient recruitment materials, including brochures, flyers, posters, and website content. Our culturally adapted translations increase patient understanding and engagement, enhancing your recruitment efforts and improving overall study success.
With expertise in medical device translation, we accurately translate user manuals, labeling, instructions for use (IFUs), product specifications, and regulatory submissions. Our translations enable end-users, healthcare professionals, and regulators to comprehend device functionality, safety instructions, and usage guidelines.
Quality Assurance and Validation:
Hansem Global places a strong emphasis on quality assurance. Our translation process includes rigorous quality control measures, such as translation validation, proofreading, and editing, to ensure the highest standards of accuracy and reliability. We employ qualified translators with subject matter expertise and follow industry best practices to deliver precise and validated translations.
Cultural Adaptation:
Hansem Global understands the significance of cultural adaptation in effectively communicating with diverse audiences. Our translators adapt translations to the target region’s cultural norms, practices, and preferences, ensuring that the translated materials resonate with the local audience and effectively convey your message.
Hansem Global is a trusted provider of linguistic validation services adhering to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. Our meticulous process ensures accurate and culturally appropriate translations and adaptations, preserving conceptual equivalence, linguistic clarity, and cultural relevance.
Following ISPOR standards, we employ a rigorous methodology that includes linguistic and cultural analysis, translation, cognitive debriefing, and iterative refinement. This comprehensive approach guarantees the highest level of reliability and validity for your assessment tools across languages and cultures.
By partnering with Hansem Global for linguistic validation, you can confidently collect meaningful and comparable data in clinical trials, real-world studies, and healthcare research. Our expertise ensures that your PROs and COA / eCOAs accurately capture the patient experience, supporting informed decision-making and facilitating global regulatory submissions.
Unlock the power of reliable and valid assessments with Hansem Global’s linguistic validation services. Contact us today to discuss your specific requirements and leverage our expertise to enhance the success of your research endeavors.
