The Impact of the New European Union Medical Devices Regulations (EU MDR) 2017/745 and MDR 2017/746
This paper provides an overview of the European Union Medical Device Regulations (EU MDR) 2017/745 and MDR 2017/746 and their impact on device manufacturers.
Translation and Comprehension of Disease Activity
With the growing use of patient-reported outcomes (PRO), it is becoming increasingly important to iron out any language barriers and translation issues to achieve the most reliable results possible. The objective of this Linguistic Validation study was to identify terminology found in PROs that causes difficulty in translation and comprehension.…
The Importance of Concept Elaboration Guides in Linguistic Validation and Recommendations for Development
The objective of this study was to review and analyze Concept Elaboration Guides (CEGs) created for Clinical Outcomes Assessments (COAs), and then identify the most beneficial approaches for building CEGs from a localization and cognitive interview perspective. This study was selected for presentation at the International Society for Quality of…
A Case Study of Successful Collaboration on a Global Immunology and Dermatology Phase II Study
A review of the Clinical Outcome Assessment (COA) Licensing, Translation and Linguistic Validation and eCOA Migration study between Kayentis and RWS Life Sciences.
Aligning Strategies and Deliverables for Global eCOA Translation Submissions to Ethics Committees in Clinical Trials
Have you ever wondered how to best align your strategies and deliverables in clinical trials when delivering eCOA translation submissions to ethics committees? This research, selected for presentation at DIA Global in Boston, June 2018, addresses this question and proposes specific solutions.
Getting The Words Right: Device Documentation And Translation In Asia
The medical device sector has seen increasing harmonization of regulations on both a global and regional basis. Nonetheless, market-entry requirements retain a significant degree of localization, particularly in relation to product labeling and documentation. Asia is no exception. For device companies prepared to negotiate the obstacles, though, the potential rewards…
An Investigation of Issues in the Translation and Comprehension of Disease Activity in Patient Reported Outcome (PRO) Measures
The RWS Life Sciences Linguistic Validation and Survey Analyst Teams carried out a study investigating the issues in the translation and comprehension of diseases activity in Patient Reported Outcome (PRO) measures. Learn about what the research entailed, the results of the study and concluding thoughts by viewing RWS’s research poster.
Variation in Interpretation of Fatigue Across Neuro-QoL – Fatigue – Version 1.0 Translations
The Research team explores the interpretation of fatigue across translations of the Neuro-QoL – Fatigue – V1.0 , adapted from PROMIS(R) item bank questions. Because fatigue assessment can measure impact on physical, mental, and social domains, one should consider the variation of interpretations across languages and disease sufferers.
Cross-Cultural Adaptation of Pictorial Images in the Free and Cued Selective Reminding Test with Immediate Recall (FCSRT-IR) in 29 Languages for 24 Countries for Use in a Mild Cognitive Impairment (MCI) Population
This study investigates the use of cross-cultural images in clinician-administered tests and exercises. The RWS Life Sciences Survey Research Analyst Team presented this research at the International Society for Quality of Life Research’s 24th Annual Conference in 2017. Click to read the study aims, results and conclusions and what implications those…
Successful Translation and Linguistic Validation of COAs: the Impact of Language Selections for Modern Chinese Populations
As the scale and frequency of clinical trials conducted in the Asia-Pacific region has increased, pharmaceutical and life sciences companies have encountered challenges in selecting the appropriate written variants of Chinese in a variety of countries. Selecting the appropriate variant is particularly important when translating and linguistically validating Clinical Outcomes…
Exploratory Analysis of the Reasons for Creating Worldwide Translations of Patient Reported Outcome (PRO) Instruments
In an effort to achieve greater consistency in PRO translations, some stakeholders request that “worldwide” translations be created (e.g., Spanish for use in all Spanish-speaking countries) rather than country-specific versions. To further explore the positive and negative consequences of this approach, the RWS Life Sciences Survey Analyst Team evaluated which…