Linguistic Validation Course

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Linguistic Validation Course

Linguistic validation consultant training for medical translators

This is an independent course that belongs to the field of linguistics , translation , and • It is intended for professional development and has been specially designed for training medical translators who wish to work as linguistic validation consultants LVCs in country consultants in country team leaders , or who are so already but want to expand in their knowledge of the specialty • You will learn all the required concepts , methodology and “ know how ” to provide quality services for the Translation and Cultural Adaptation of Clinical Outcome Assessments COAs ) and other medical instruments that are frequently used in clinical trials and medical research

400,00 €

  • Available

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AoD LINGUISTIC VALIDATION COURSE FOR LVC
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Medical Sciences: Linguistic Validation

 

 

Linguistic validation is growing exponentially due to the vast increase in these later years of a demand for the translation and cultural adaptation into multiple languages and variants of Clinical Outcomes Assessments (COAs), mostly Patient-Reported Outcomes (PRO) and Quality of Life (QoL) measures, Clinician-Reported Outcomes (ClinROs), Observer-Reported Outcomes (ObsROs) and Performance Outcomes (PerfOs), as well as preparation and migration of translations for use on electronic platforms (eCOA), and other instruments. The main reason is that multinational clinical trials and medical research is multiplying worldwide, and the instruments need to comply with ISPOR and FDA guidelines, which make this service a highly skilled and complex one, but also greatly rewarding in medical humanities terms as well as professionally. 

 

Patients are at the heart of what we do in linguistic validation, and how they feel and function as well as their quality-of-life are increasingly becoming very important aspects in the pharma product development industry.

Through this service, we help patients understand and express how they feel and function in their own language so that they may be able to “have a voice” in medical research and clinical trials. These instruments are also used in usual clinical practice and help diagnose and assess patients in an enormous range of medical conditions.

 

As a linguistic validation consultant and coordinator I provide services for Contact Research Organisations (CROs) and Medical Translation Agencies of Medical Questionnaires, Clinical Outcomes Assessments (COA), and preparation and migration translations for use on electronic platforms (eCOA), Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinROs), Observer-Reported Outcomes (ObsROs) and Performance Outcomes (PerfOs).

 

As a linguistic validation developer and advisor I design and develop the complete Linguistic Validation Service for implementation in LSPs; auditing for them on a regular basis for support, and to ensure up-to-date services and good practices as per ISPOR and FDA guidelines. LSPs receive a caring and committed partnership.

 

Linguistic Validation (LV) Services

  • LV Service Development & Implementation (creation, development, and training for LV Services implementation)
  • LV Service Consultancy & Support (audits for quality control, updates, and benchmarking)
  • LV Project Coordination (project lead and linguistic management)
  • LV Project Consultancy for EN-ES (all LV stages, including patient recruitment, cognitive debriefing interviews, and clinician recruitment)

 


LINGUISTIC VALIDATION AND CULTURAL ADAPTATION PROCESS


Forward Translations, Backward Translations, Harmonization, Cognitive Debriefing, Clinician Reviews, Editing, Proofreading and Finalization



COGNITIVE DEBRIEFING SERVICES (PATIENTS INTERVIEWS)

I recruit and conduct cognitive debriefing interviews with patients from the general population and with any required condition.

CLINICIAN REVIEW SERVICES

I recruit clinicians in any area of specialization to perform clinician reviews for ClinROs and other COAs requiring the eyes of an expert.

Samples of Linguistically Validated and Translated Texts


Medical Questionnaires

Clinical Outcomes Assessments (COA)

 

Translation and linguistic validation of Medical Questionnaires, Clinical Outcomes Assessments (COA), and preparation and migration translations for use on electronic platforms (eCOA), Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinROs), Observer-Reported Outcomes (ObsROs) and Performance Outcomes (PerfOs).

https://eprovide.mapi-trust.org/

 


BiblioPRO

Biblioteca Virtual de referencia científica internacional de los cuestionarios en español de Resultados Percibidos por los Pacientes (PRO - Patient Reported Outcomes).

 

 

 

 

ePROVIDETM is a platform providing access to information on Clinical Outcome Assessments (COAs).