Specialist Expertise
Access to experienced COA and clinical research professionals according to project requirements.
Services
We support clinical trial sponsors and CROs with early COA planning, bringing in experienced COA and clinical research professionals according to the needs of each study.
Our support can help clinical trial sponsors understand the patient experience, assess available outcome measures and determine an appropriate measurement approach for the intended study population and context of use. Depending on the project, this may involve patient and disease research, literature and COA landscape reviews, conceptual framework development, COA evaluation and selection, endpoint planning, or support for the development or modification of PRO, ClinRO, ObsRO and PerfO measures.
Relevant clinical, regulatory and HTA considerations can be incorporated into the planning process, alongside downstream requirements such as COA licensing, translation, Linguistic Validation and eCOA implementation.
COA Planning & Consulting focuses on identifying what should be measured, in which population and context, and which measurement approach or instrument may be appropriate. Once an instrument has been identified, COA Licensing & Management can address the permissions, versions, available translations and requirements for its intended use.
Pathway
Once the COA strategy is established, we can help coordinate the subsequent pathway through COA licensing and management, translation and Linguistic Validation, and eCOA migration support, providing continuity from early planning through implementation.
Why NN Translations
Access to experienced COA and clinical research professionals according to project requirements.
A pathway from early COA planning through licensing, Linguistic Validation and eCOA implementation.
Support can be tailored to the study, development stage and specific COA requirements.
Questions
When should COA planning begin?
COA planning should ideally begin early in study design, when the concepts and outcomes to be measured, target patient population, context of use and intended measurement approach are being established. Early planning can also help identify downstream requirements for COA licensing, translation, Linguistic Validation and eCOA implementation before they affect study timelines.
What can a COA landscape review involve?
A COA landscape review can involve reviewing available outcome measures relevant to the disease area, target population, concepts of interest and intended context of use. Depending on the project, this may include literature review, evaluation of existing PRO, ClinRO, ObsRO and PerfO measures, and consideration of their suitability for the intended study.
How do COA planning and endpoint strategy connect?
COA planning can support the development of an appropriate measurement approach by considering which outcomes are important to measure, how they relate to the study objectives and which COAs may be suitable for assessing them. Clinical, regulatory and HTA considerations can be incorporated according to the requirements of the project.
What happens if no suitable existing COA is available?
Where existing instruments do not adequately address the intended concepts, population or context of use, the study team may need to consider modification of an existing measure or development of a new COA. The appropriate approach depends on the study objectives, available evidence and applicable clinical, regulatory and measurement requirements.
How does early COA planning affect licensing, Linguistic Validation and eCOA implementation?
Decisions made during COA planning can determine which instruments require licensing, which language versions are needed, whether validated translations already exist, what Linguistic Validation activities may be required and how the COA will subsequently be implemented electronically. Considering these requirements early can help create a more coordinated pathway from COA strategy through licensing, Linguistic Validation and eCOA migration.
Whether you are defining your COA strategy, evaluating existing instruments or preparing for licensing and implementation, talk to us about the support your study requires.