Linguistic Validation

Patients are at the heart of what we do in 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, FDA and EMA guidelines, which makes 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 linguistic validation consultants and project coordinators we provide services for Sponsors, 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 linguistic validation mentors and advisors we provide business consultancy services to companies; auditing for them on a regular basis for support, and to ensure up-to-date linguistic validation services and best practices. Sponsors, CROs and LSPs receive a caring and committed partnership.

Linguistic Validation Consultancy for English to Spanish for Spain (EN-spaES). All LV stages, including patient recruitment, cognitive debriefing interviews, and clinician recruitment.

Linguistic Validation Project Coordination (project lead and linguistic management).

Linguistic Validation Service Consultancy & Support (audits for quality control, updates, and benchmarking).

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).

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