Over the past few years machine translation, particularly Google Translate has come into its own and its use has been increasing rapidly. In 2012, Google announced that more than 200 million people were actively using it monthly. Given that using Google Translate can often provide an accurate translation, translation agencies are often asked why it cannot be used in clinical research and with Clinical Outcomes Assessments (COA) as opposed to going through an expensive and time-consuming linguistic validation and cultural adaptation process.
This webinar will explain and provide examples to illustrate the importance of cultural adaptation and the steps in the linguistic validation process. The points will be made from a linguistic as well as a regulatory perspective paying particular attention to recent developments in the COA field.
- Discover what linguistic validation is and why it is important
- Review ISPOR guidance
- Discover what cultural adaptation is and why it is important
- Focus on methodological challenges presented when there is no human involvement in a translation
- Discuss challenges
Adelina Lear, BA, Strategic Account Executive, ICON Language Services
Adelina Lear, Account Executive of Linguistic Validation at ICON, is responsible for overseeing the linguistic validation of clinical outcomes assessments including both paper and electronically administered assessments (eCOA). Since joining ICON in 2012, she has managed over 2500 translation projects for large and mid-sized pharma companies spanning more than 130 languages. Adelina’s expertise is in and around translation methodology within the clinical space including both ISPOR and FDA translation guidance and regulation. Adelina holds a BA in French and Hispanic Studies from Exeter University and is bilingual in Italian.
Diane Wild, MSc, Consultant
Diane has over twenty years of experience in health research, sixteen years of which have been spent in patient reported outcome (PRO) research. She is the founder of Oxford Outcomes Ltd (acquired by ICON in 2011) and former Vice President ePRO and Translations at ICON plc. Diane has worked on and managed a large number of UK-focused and international projects, and has particular expertise and interest in cross-cultural PRO research and in methods relating to linguistic validation. She has an MSc in Health (1992) and prior to setting up Oxford Outcomes, was a researcher in the NHS and at the University of Washington.
Who Should Attend?
This program is intended for senior level professionals at biopharmaceutical companies working in:
- Regulatory Affairs
- Late Phase Research
- Project Management
- Patient Registries
- Risk Management
- Market Access
ICON Commercialisation & Outcomes optimises the value of drugs and medical devices through innovative strategies and tactics that reflect evolving evidentiary, regulatory, and reimbursement requirements. Our expert team establishes and communicates a product’s unique clinical and economic outcomes to achieve success in today’s dynamic and patient-centric healthcare environment.