We are Linguistic Validation Experts.
Linguistic Validation is the highly technical process that involves a series of complex steps that include forward translation, localization, back translation, and field testing of the linguistically adapted documents. Our linguistic validation services involve the phases of the assessment, harmonization, translation, clinician reviews and cognitive debriefing that ensure conceptual equivalence & international harmonization.
Here are the steps followed to perform Linguistic Validation:
Step 1: Forward Translation
The process of linguistic validation starts from forwarding translation. This process involves at least two translators who help to render the essential source material into targeted language. The process of forwarding translations is executed by skilled and experienced translators who are specialists in the native language and also professional in the study. Moreover, the translators should be clinicians, doctors, psychiatrists, social workers, various established professionals, and not those who are bilingual.
Step 2: Reconciliation
Reconciliation is the next step for the linguistic validation process. You have to evaluate the forward translations and then settled it into the version which combines the best from both of the forward translations. The reconciled version must be conceptually equivalent to the exact source. Transcreation might be more apt than that of the word-for-word translation. Sometimes, the accurate translation results in an unplanned subtle shift in the aim language. Moreover, the harmonized translations have to be easier to recognize in the conversational language of your target audience.
Step 3: Back Translation
Now translate back the reconciled translation into its original source language. The process of back translations will be executed by at least two independent translators who do not see the original source document.
Step 4: Final Review & Corrected Translation
When the back translation process is finished, the project manager re-examines the back translations with the original source document. He also concludes – is the harmonized translation is accurate and linguistically valid along with the original? To this stage, the project manager, translation team, and/or in-country investigator work together and produce the final proper translation.
And, when this process of linguistic validation completed, most of the project manager wants to test validated instrument to make sure that the respondents in target locations understand the items & responses in such a manner that it shows the correspondence of meaning. This is generally completed via cognitive debriefing.
Translation & Linguistic Validation of Patient Questionnaires at STELLAR LINGUISTIC SOLUTIONS
The good translation services are not only designed to replace once language into another format, but, it should follow the authentic meaning & it is culture-specific, as well. While some are only for the common translations.
Now, comes to patient Reported Questionnaire which is used in clinical trials, they demand balanced & well-appointed cultural values along with an appropriate translation. Let us take an example; the term ‘bowling’ is used in the Quality of Life Questionnaire which comes to the ability to execute sports activities and a simple translation will not complete the actual purpose as there is a wide array of the population who are not able to consider bowling as the characteristic sports activity. Thus, the proper localization of a particular region and language will demand another activity having equal construct value. Thus, it is important for the patient who is reported questionnaire is culturally appropriate along with the linguistically validated translations, if not; the instrument affects the accuracy of required research data.
Outlining of Linguistic Validation Process
With the beginning of the new millennium, globalization will speed up and along with various other research devices, the clinical trial processes are corralled character. Various authorities like FDA & EMEA locate the new & strict guidelines for using PRO or Patient Reported Outcome to determine endpoint from the international clinical trials to support brand claims.
Moreover, the FDA has made it crucial for all clinical research sponsors to offer the verification & measurement properties of the instrument that are effectively similar between all versions which are used in trials.
Linguistic Validation Process
STELLAR LINGUISTIC ensures that their team is following the methods and processes which are recommended by the International Society for Pharmacoeconomics & Outcome Research ISPOR.
Our wide and extensive network of experts is extending regularly and we have Linguists, Clinicians, Project Managers, etc. who associated with us all around the world and enable us to make our clients happy and fulfilled to the core.
We have specialists working with us from the following medicine branches:
• Central Nervous System (CNS)
• Women’s Health
• Psychiatry (including depression, schizophrenia, anxiety)
Advantages of Linguistic Validation with STELLAR LINGUISTIC SOLUTIONS
At STELLAR LANGUAGE SOLUTIONS, we ensure that our customers feel completely satisfied regarding the accurate translation of all the items & the interpretation at par with region & target population. This data can be pooled logically across various international sites & our whole process meets FDA & EMEA guidelines.
We provide our services for Linguistic Validation with appropriate skills and talent, we have a portfolio that we would like you to see and discuss our service one-on-one. Thus, by starting a new team for your next linguistic validation service, we would request you to talk to us & explore numerous benefits from our years of experience.