Clinical Outcome Assessment
Your One-Stop Solution for COA Licensing and Management
Including Clinical Outcome Assessments in research is encouraged by the FDA and other regulatory agencies in all research phases and designs: randomized clinical trials, decentralized clinical trials or real-world evidence trials.
Think ahead and start planning including COAs as your research outcome measures – we're here to support you with the entire process: from license research, contracting and providing additional languages using the internationally recognized linguistic validation methodology.
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
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.
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 email@example.com
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