We conduct comprehensive gap analyses of Clinical Outcome Assessment (COA) strategies and evidence to evaluate the adequacy for regulatory submission and payer acceptance. Our expertise supports the identification and resolution of gaps in content validity, psychometric properties, and thresholds of meaningful change, thereby ensuring COAs are fit-for-purpose prior to their implementation in pivotal clinical trials.

As patient-centered evidence is more and more required by regulators as well as payors, it is key to understand the patient experience. We support you by defining concept(s) of interest by gathering insights through concept targeted literature reviews. Patient and expert interviews may be facilitaed and connducted by a third party.

We systematically identify and evaluate Clinical Outcome Assessments (COAs) to ensure alignment with the study’s target population, therapeutic area, and regulatory expectations. Potential COAs are identified through instrument targeted literature reviews and landscape assessments. Further, a structured mapping of COAs against the concepts of interest and intended clinical endpoints enable a clear assessment of their relevance and appropriateness. We further consider the evidentiary basis supporting COAs, including content validity, psychometric properties, cinical meaningful threshold, and feasibility of implementation, to inform the selection of the most suitable measures for clinical development and regulatory submission.

Once you have all your COA-related evidence, we help you write publications or regulatory documents such as COA dossiers or support you with compiling presentations.

We conduct comprehensive gap analyses of Clinical Outcome Assessment (COA) strategies and evidence to evaluate the adequacy for regulatory submission and payer acceptance. Our expertise supports the identification and resolution of gaps in content validity, psychometric properties, and thresholds of meaningful change, thereby ensuring COAs are fit-for-purpose prior to their implementation in pivotal clinical trials.

As patient-centered evidence is more and more required by regulators as well as payors, it is key to understand the patient experience. We support you by defining concept(s) of interest by gathering insights through concept targeted literature reviews. Patient and expert interviews may be facilitaed and connducted by a third party.

We systematically identify and evaluate Clinical Outcome Assessments (COAs) to ensure alignment with the study’s target population, therapeutic area, and regulatory expectations. Potential COAs are identified through instrument targeted literature reviews and landscape assessments. Further, a structured mapping of COAs against the concepts of interest and intended clinical endpoints enable a clear assessment of their relevance and appropriateness. We further consider the evidentiary basis supporting COAs, including content validity, psychometric properties, cinical meaningful threshold, and feasibility of implementation, to inform the selection of the most suitable measures for clinical development and regulatory submission.

Once you have all your COA-related evidence, we help you write publications or regulatory documents such as COA dossiers or support you with compiling presentations.