*The linguistic validation process has been developed within the industry and undergoing careful scrutiny for the last 20 years. The following are the most notable papers based on which the present methodology is derived:
Wild, Diane et al. “Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation.” Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research vol. 8,2 (2005): 94-104. doi:10.1111/j.1524-4733.2005.04054.x
Coons, Stephen Joel et al. “Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report.” Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research vol. 12,4 (2009): 419-29. doi:10.1111/j.1524-4733.2008.00470.x
Wild, Diane et al. “Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force report.” Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research vol. 12,4 (2009): 430-40. doi:10.1111/j.1524-4733.2008.00471.x
Acquadro, Catherine et al. “Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures.” Journal of patient-reported outcomes vol. 2,1 (2017): 8. doi:10.1186/s41687-018-0035-8
Eremenco, Sonya et al. “Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices.” Journal of patient-reported outcomes vol. 2,1 (2017): 12. doi:10.1186/s41687-018-0037-6
McKown, Shawn et al. “Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures.” Journal of patient-reported outcomes vol. 4,1 89. 4 Nov. 2020, doi:10.1186/s41687-020-00248-z
We Support 170+ Languages & Countries
Be confident that your research includes the voices of patients from more than 170 languages and countries.
In addition, Cognitive Debriefing is performed in the same countries where your trial is being launched, ensuring conceptual equivalency and cultural appropriateness of the COA translations.
The process in turn ensures the validity, reliability and comparability of the collected data. We're especially proud of our great results with patient and clinician recruitment.
Taking Care of Them All
Request Linguistic Validation for any of the four COA types.
We employ scientifically backed methodologies, ensuring the reliability and comparability of the data collected throughout your study.
Patient Reported Outcome (PRO/PROM) instruments
Observer Reported Outcome (ObsRO) instruments
Clinician Reported Outcome (ClinRO) instruments
Performance Outcome (PerfO) instruments
With Borliner you are getting supportive partnership with a nurturing relationship – accelerating your progress with meeting regulatory timelines.
We Check All the Boxes
Internationally recognized methodology per ISPOR's Linguistic Validation guidelines.
We're working with your eCOA vendor and all other relevant stakeholders to meet the regulatory timelines, including supporting you with adhering to the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) process and timelines.
Linguistic Validation methodology per ISPOR's guidelines
A broad network of in-country consultants and translators
The best translators working exclusively into their mother tongue
More than 100 countries and languages supported
What Clients Say About Us
“Oxford University Innovation stands for excellence and Borliner has delivered many of our projects to that exact standard. We have worked with Tomislav, the founder, and it was a pleasure working with him on straightforward and complex projects alike. Always available, quick to respond, helpful and personable - an example of integrity.”
Marlene J. Knupfer, Linguistic Validation and eCOA Manager – Clinical Outcomes
Why Us?
The Best From Both Worlds
Our experts and consultants are highly experienced medical translators, largely with healthcare, life sciences' or scientific backgrounds and proprietary networks of clinicians.
Personalized service – work with the same expert during the project to ensure personal dedication.
We can help you with 100+ languages around the globe.
Large network of in-country experts and associates for all of your needs.
Unbeatably quick turnaround times.
FAQ
Frequently asked questions about our services.
How quickly can you perform linguistic validation and licensing?
The speed of performing linguistic validation and licensing depends on a number of factors. Having established relationships with a number of COA authors and copyright holders, we shoot for the shortest possible timelines. Linguistic validation takes two months on average after ensuring the translation permission from the copyright holder.
Speed of the process is our second priority we're extremely proud of. The first one is quality.
How can we know that the requested COA questionnaire is properly linguistically validated?
Our Linguistic Validation methodology is aligned with the guidelines issued by the International Society for Pharmacoeconomics Research (ISPOR). ISPOR's guidelines are the conditio sine qua non acknowledged also by the FDA and internationally accepted. The process is thoroughly documented and the documentation is provided to the client together with the validated COA questionnaires and the linguistic validation certificate (for regulatory submission purposes).
Can we just have the COA questionnaire translated with our local translation company?
Linguistic Validation is mandatory if you intend to use the COA as an outcome measure in clinical or scientific research. The purpose of Linguistic Validation is to ensure the conceptual equivalence of the COA's questions, which ensures the reliability and comparability of the collected data from different countries and languages. A simple translation does not ensure this, and for regulatory submission purposes a Linguistic Validation certificate is required.
Additionally, the permission for translation is required from the copyright holder prior to translating any COAs in other languages. Considering the level of scientific effort and precision required for COA questionnaire development, the developers and copyrights holders are fully aware of the importance of the high-level requirements of the Linguistic Validation methodology.
How can we obtain a license for a COA questionnaire?
What does the licensing process entail? The COA licensing process starts with your inquiry and providing us with the basic data regarding the use of the questionnaire (whether it is a commercial clinical research study or is it academic non-profit research etc.). We conduct the research on the copyrights ownership, establish a relationship (if not already existing) with the copyrights holder, obtain permission for translation and linguistic validation, define the licensing conditions, and perform the entire contracting procedure until both parties have signed the agreement.
We take your regulatory timeliness into consideration and make any effort to have your research on track and in time for any submissions. Get in touch.
We started linguistic validation with a different service provider but the project got delayed due to difficulties with recruiting patients for the cognitive debriefing interviews. Can you help?
Of course. Our network of consultants covers more than 100 countries and languages. We are proud to have on board some of the most experienced medical translators and linguistic validation consultants out there, many of which being active medical doctors or other healthcare professionals.
We're equally proud of our ability to stand out and jump in when the project is delayed and the clock is ticking.
We have supported clients with dealing with difficult projects, jumping in when a different service provider wasn't able to ensure clinician review by a rare medical specialty in the middle of summer vacation season, or finding sources of patients for extremely rare conditions.
It is our goal to provide you with peace of mind when working with us – we'll take care of the COAs and Linguistic Validation, while you're taking care of the rest.
Still have questions? Email us at info@borliner.eu
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