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)

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.

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/