Prioritizing Patient Safety While Pursuing High Quality Data
While COVID-19 has frozen much of the world, healthcare marches on. The studies that will determine the safety and efficacy of health-improving and life-saving drugs must continue. But now, attending scheduled site visits and collecting critical information from patients have become safety issues for patients and trial staff alike. How…
Operation Collaboration- RWS & Clinical Ink
How RWS and Clinical Ink worked together to streamline processes, drive efficiency, and generate cost-savings for clinical trial sponsors
European Medical Device Regulation 2017/745 (MDR) • The Future Starts Now
The EU MDR will have sweeping effects on company audits, budgets and ROI assessments, and even CE mark certification. And, with 24 official EU languages to grapple with, MDR has presented myriad linguistic challenges, even to the most sophisticated medical device manufacturers. It’s time to prepare—for May 2020 and beyond.…
The Exciting Journey of MT Deployment in the Life Sciences Industry
In this webcast, you will learn how to:
* Understand the use case of AI and NMT in highly regulated industries.
* Assess the risk of failure against the benefits of deploying NMT and AI on your clinical and regulatory content.
* Leverage best practices for the responsible application of NMT and AI on your current content profile, so you get the best results in your MT efforts.
Beyond Translation: The Centralised Procedure
In this webcast, RWS experts discuss the expectations of the language solutions provider in its role within centralised procedure projects and explore how to go ‘beyond’ translation in order to reduce the administrative burden on the pharmaceutical company.
Listen as we discuss “At Risk” translations, QRD compliance, Member-state review, administration of bookmarked PDFs and Appendix V files, as well as workflow and deadline management.
Patient-reported Outcome Measure Translation: An Overview
The unique nature of patient-reported outcome (PRO) measures presents unique challenges for translation. This article, published in Medical Writing, December 2018, provides an overview of the central issues affecting PRO measure translation, best practices for PRO measure translation and ways to improve the translatability of PRO measures at the development…
Usability Testing: Ensuring User–friendly Data Collection in Clinical Trials
Usability testing is recommended to verify that Patient-Reported Outcome (PRO) questionnaires migrated from their original paper version, into another format like an app, have the same properties of reliability and validity in both formats. However, our research shows usability testing is more effective when cognitive debriefing is de-emphasized during this process.…
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 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.
An Investigation of Issues in the Translation and Comprehension of the Terms “Self-conscious” and “Embarrassed” in Patient Reported Outcome (PRO) Measures
Identifying problematic terminology and proposing solutions for improved translation is critical to increasing PRO content validity and the quality of respondent data. This research, selected for presentation at ISPOR Europe in Barcelona, November 2018, examines patients’ comprehension of the terms “self-conscious” and “embarrassed”, which have considerable semantic overlap and frequently…
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…