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.
Hansem Global’s Life Sciences Translation Division is committed to providing Linguistic Validation for eCOAs (electronic Clinical Outcome Assessments) in accordance with the guidelines set forth by ISPOR (International Society for Pharmacoeconomics and Outcomes Research) and FDA (U.S. Food and Drug Administration). Here’s an explanation of how we ensure compliance with these guidelines:
Familiarity with Guidelines:
Hansem Global’s team in the Life Sciences Translation Division is well-versed in the specific guidelines and recommendations outlined by ISPOR and FDA regarding Linguistic Validation of eCOAs.
We stay up-to-date with the latest revisions and updates to these guidelines, ensuring adherence to the most current standards.
Hansem Global follows a rigorous, systematic, and evidence-based approach to Linguistic Validation, aligning with the principles and best practices recommended by ISPOR and FDA.
We apply the recommended steps, including forward and back-translation, harmonization, cognitive debriefing, and expert review, to ensure linguistic and cultural equivalence of the translated eCOAs.
Translator Selection and Training:
Hansem Global carefully selects translators with expertise in the therapeutic area relevant to the eCOAs being translated.
Translators undergo specialized training on the specific guidelines provided by ISPOR and FDA for Linguistic Validation, ensuring they have the necessary knowledge and skills to meet the requirements.
Harmonization and Cognitive Debriefing:
During the harmonization process, Hansem Global ensures that the translated eCOA instruments are conceptually equivalent to the original versions, as recommended by ISPOR and FDA.
Cognitive debriefing interviews follow the recommended guidelines to gather feedback on the clarity, relevance, and cultural appropriateness of the translated eCOAs, as specified by ISPOR and FDA.
Hansem Global engages experts with knowledge and experience in the therapeutic area and eCOA development, following the recommendations of ISPOR and FDA.
The experts conduct a comprehensive review of the translated eCOA instruments to ensure linguistic and cultural equivalence, accuracy, and adherence to the guidelines.
Hansem Global provides a detailed validation report that aligns with the requirements outlined by ISPOR and FDA.
The report includes information on the translation process, harmonization efforts, cognitive debriefing results, expert review outcomes, and any revisions made during the linguistic validation process.
By adhering to the ISPOR and FDA guidelines, Hansem Global’s Life Sciences Translation Division ensures that Linguistic Validation for eCOAs meets the standards required for regulatory submissions and supports clients in their efforts to develop and validate accurate and culturally appropriate eCOAs in accordance with these guidelines.