Linguistic Validation

World Leaders in Linguistic Validation

Since 1987 Health Outcomes Group has been a leader in establishing the methodology for translating and linguistically validating Patient Reported Outcomes instruments (PROs). We created the first Standard Operating Procedures for translation and linguistic validation of health related quality of life instruments in 1992 and these standards are the foundation of the ISPOR Guidelines that are the industry’s quality standard today. David Himmelberger, CEO of Health Outcomes Group, was a member of the ISPOR Task Force that created those SOP’s - the Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures in 2005.

Using the Natural Language of Patients

Effective communication begins by understanding the background, culture and educational level of your audience. We avoid DOC talk used by physicians and draw upon the natural language with simple terms that the audience understands in the same manner you intended.

Maintaining Linguistic Equivalence

It is not sufficient to communicate concepts that are conceptually equivalent. Equivalent experiences must yield equivalent data in every language translated. This an essential requirement in order to pool data from multinational clinical trials for a single statistical analysis.

Confirming What Patients Really Understand

The linguistic validation replicates the setting in which the instrument
is intended to be used. Our linguists are more than translators, they are experienced in a range of qualitative techniques, including conducting personal interviews and focus groups in a culturally sensitive manner.

• Translation and Linguistic Validation Methods (Read More)

Scientific Methodology

We use accepted methods and provide certification of translations that guarantees a level of quality that meets and exceeds the standards required by FDA, EMA and other international regulatory agencies.
We insure that the data collected from different countries by patients speaking different languages are linguistically equivalent and can be combined
for a pooled statistical analysis.

Certifications

Health Outcomes Group works to the standards of the ISO 17100 Standard (replaces EN 15038) for quality assurance. Published by the European Committee for Standardization, ISO 170100 provides standards for measuring the quality of translation services, and also defines requirements for service delivery, quality control and creates a framework for customer interaction.

Maintaining High Professional Standards

Our attitude toward operational excellence is that quality is a continuous effort that permeates every action by each employee for every activity. We are members of the American Translators Association, the Northern California Translators Association and collaborate with many other international translation societies.

Health Outcomes Group