Validation and Country-Specific Adaptation of PROs for Clinical Studies 

TransCom specializes in validation and country-specific adaptation of PROs (e.g. psychiatric scales, quality of life (QoL) questionnaires etc.) to achieve psycholinguistic and conceptual adequacy, ensuring an equivalent version of any rating scale or questionnaire for all the countries in multinational clinical trials.
The validation and adaptation process is done by an elite team of expert consultants from the following disciplines: 

• Psychiatrists
• Neurologists
• Neuropsychologists

TransCom's work in this area is unique in the industry  - our focus on PROs and unique combination of language, medical and scientific experts enables us to provide the most professional, accurate and meticulous end product that was created following a multi-phase process, including:
 

• Cultural adaptation
• Identifying and solving non-translatable linguistic obstacles
• Forward translation
• Back translation
• QA process (review of back translation vs. original text)
• Adaptation
• Validation

Our Expertise helps your PROs-based trials succeed

Our unique advantages:

• All language processes take place under the same roof.
• Top level of medical professionals, all experts in PROs
• Rigorous quality assurance measures
• Short timelines
• Unparalleled pricing levels

Make us your best partner for PROs-based trials worldwide.

TransCom's PROs department employs numerous neurologists, psychiatrists, licensed neuropsychologists and physicians of various medicine disciplines from 5 continents, specializing in linguistic and cultural validation and adaptation of PROs.

The unique and close cross-departmental cooperation between all employees - neurologists, psychiatrists, neuropsychologists, physicians, senior medical translators, QA specialists and transcribers - ensures maximum quality and accuracy as well as matchless quick turnaround times.

Psychiatric Scales & Quality of Life Questionnaires
The first stage of adaptation of documents for multinational trials is translating them into the languages of the countries that participate in the trial. Scales and questionnaires are translated at TransCom by medical language experts, all completely fluent in English and native speakers of the target language. Following translation, the documents are back-translated into English and forwarded to the validation/QA department, where the forward translation is being compared to the back-translation. When the validation process is completed, the documents are forwarded to the appropriate specialist: psychiatrist / neuropsychologist / physician of the relevant medicine discipline. The document is being harmonized to ensure:

• That the translated document is conceptually equivalent to the original document.
• That the translated document is culturally suitable for the population in the target country.
• That the translated document is psychometrically identical to the original document

Upon completion of harmonization process, the documents are forwarded to the clients with a Translation, Validation & Harmonization certificate, which includes all the relevant details (type of document, version, date, names of translators, QA specialists and consultants).

Rater - Patient Interviews
Clients can upload to TransCom's strong FTP server recorded interviews in any types of audio files (MP3, DVD, WAV etc.) with. The files are converted if necessary and the interviews are transcribed by professional transcribers with vast experience in transcription of rater-patient interviews.   

The transcribed interviews are reviewed for linguistic and cultural obstacles, and all issues are solved with the client prior to translation.

The interviews are translated into various languages as required, by translators who are native speakers of the target language and have extensive experience in translation of interviews. 

The forward translations are then back-translated into English by translators whose area of expertise is back-translation.  

Upon completion of the translation and back translation process, the interviews are forwarded to the QA department, where extra care is being given to translatability of difficult items such as slang expressions, puns, culture-specific words etc. the QA process is done by experienced QA specialists, and when required - by psychologists.

Upon completion of the QA process, the interviews are harmonized undergoing the same process of harmonization as scales and questionnaires.

Upon completion of the harmonization process, the translations are forwarded to the clients with a Translation & Validation certificate, which includes all the relevant details (type of document, version, date, names of transcribers, translators and QA specialists).