Clinical Outcome Assessment

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.

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).

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.
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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.

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.
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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.

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.