Forward Translation and Reconciliation
Back-Translation and Harmonisation
Creation of the Final Version
You can select a complete package for linguistic validation of the PRO instrument or just select individual steps.
CONDUCT CLINICAL TRIALS IN GLOBAL MARKETS SEAMLESSLY.
Because clinical trials are increasingly being conducted at an international level, there is also a growing need for translation and cultural adaptation of patient reported outcome (PRO) measures and for linguistic validation of the PRO instruments.
A patient reported outcome (PRO) is a measurement of any aspect of a patient’s health status that is reported directly by the patient, without a clinician or other third party interpreting the information.
It is therefore absolutely essential that the translations, cultural adaptations and harmonisations of the questionnaires/instruments used are accurate as well as being culturally and conceptually equivalent to the source instrument and are written in patients’ national languages.
Translation and linguistic validation of PRO instruments is a very complex process that ultimately aims to create a comprehensive picture of a medicinal product’s therapeutic effects.
Right from the first steps of the linguistic validation, we will help you to develop strategies for PRO instrument validation that satisfy regulatory and budgetary requirements. You will receive reliable PRO instruments which guarantee the successful implementation of your global studies.
PRO + LINGUISTIC VALIDATION – OUR NETWORK – YOUR SUCCESS
Our global network of linguistic validators and medical translators, subject matter experts, doctors, psychologists and in-country reviewers allows us to expedite each linguistic validation project while retaining scientific accuracy.
Each project is also linguistically equivalent across all languages, instilling confidence that the data can be pooled for statistical analysis.
By focusing on translating documentation for all globally active companies and CROs, we have honed our expertise in translating and harmonising PRO instruments for use in both paper and electronic formats.
Our state-of-the-art linguistic validation process ensures both precise and timely completion of your documents/instruments.
Our process for linguistic validation is modelled on the U.S. Food and Drug Administration (FDA) PRO guidance document as well as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and European Medicines Agency (EMA) GCP guidelines.
Our experience in translating PRO instruments is constantly expanding and now covers a range of therapeutic areas including rheumatology, oncology, neurology, gastroenterology, geriatrics, gynaecology and so on