Once the appropriate permissions are in place, we can continue supporting your project with comprehensive COA Translation & Linguistic Validation, including clinician review, cognitive debriefing and patient and clinician recruitment where required.
Services
Successful COA implementation starts with early planning.
The Concepts of Interest (COIs) and Context of Use (COU), outcomes to be measured, target patient population and appropriate instruments should be considered alongside required languages, licensing requirements and mode of administration during study design and ideally before protocol drafting begins.
NN Translations supports you with COA consulting, COA licensing and management, helping establish the right foundations for subsequent Linguistic Validation and electronic implementation. We bring together clinical trial professionals, COA strategy and licensing consultants, instrument developers and copyright holders, as well as eCOA providers where required.
COA selection and COA licensing are closely connected but distinct. COA Planning & Consulting focuses on what should be measured, in which population and context, and which instrument may be appropriate. COA Licensing & Management focuses on whether and how that instrument can be used, including the correct version, ownership, permissions, available translations, language requirements and permitted modes of administration.
Where instrument selection or broader COA strategy is still being established, explore our COA Planning & Consulting services →
What We Coordinate
We coordinate the process for obtaining the appropriate permissions to use COAs in clinical research, including:
Licensing research
Identification of the copyright holder, IP owner or authorised licensing representative
COA version verification
Licensing coordination
Licensing agreement coordination
Licensing fee management
Translation availability and gap analysis
Permissions for new translations and Linguistic Validation
eCOA licensing requirements
Licensing documentation and tracking
Next Steps
Once the appropriate permissions are in place, we can continue supporting your project with comprehensive COA Translation & Linguistic Validation, including clinician review, cognitive debriefing and patient and clinician recruitment where required.
For studies using electronic COAs, we provide support for eCOA migration and implementation, working directly with the clinical trial sponsor's selected eCOA vendor or, where required, with one of our trusted eCOA partners.
Timelines
The COA licensing timeline can vary, but the process may take approximately 4–6 weeks or longer. Starting the process early helps ensure that the necessary permissions and requirements are in place before translation, Linguistic Validation and electronic implementation proceed.
Early licensing helps identify the correct instrument version, copyright or licensing party, required permissions, existing language versions, translation gaps and mode of administration requirements early enough to reduce the risk of delays later in the study.
Resources
Access practical guidance, insights and supporting materials for clinical research, Linguistic Validation, COA/eCOA projects and medical devices.
Questions
How long does COA licensing take?
COA licensing timelines vary depending on the instrument, copyright holder or licensing party, intended use, study scope, required languages and modes of administration. As a general guide, the process may take approximately 4–6 weeks or longer, depending on the specific requirements and parties involved.
Does every COA require a license?
Some COAs are copyrighted and require a license or formal permission, while others may be available for public use. However, finding an instrument freely available online does not necessarily mean that it is in the public domain. Its copyright status, correct version and conditions of use should be verified before use.
Can you check whether validated translations already exist?
Yes. We can coordinate translation availability and gap analysis before new translations are initiated.
Can you manage both COA licensing and Linguistic Validation?
Yes. We can coordinate licensing and subsequently manage the required multilingual translation and Linguistic Validation process, including clinician and patient recruitment and interviews where required.
What if we need an eCOA?
Electronic implementation may involve specific licensing, permission and implementation requirements from the copyright holder. These should be identified during COA licensing and communicated to the eCOA provider before implementation begins. We coordinate eCOA implementation with the sponsor's selected eCOA provider or, where required, through our trusted partners, helping connect COA Licensing & Management, Linguistic Validation and electronic implementation within a coordinated workflow.
Schedule a call to discuss your COA and eCOA needs.