We focus on endpoints and outcomes for clinical trials.
And that is all we do.
Clinical outcome assessments (COAs), including patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO) and performance outcome (PerfO) instrument development to support labeling and marketing claims or a publication strategy.
Psychometric testing of endpoints to ensure that they are valid, reliable and responsive and demonstrate statistical and clinically meaningful differences against placebo and active treatments.
Identify existing clinical outcome assessments (COAs) that could be suitable as is or modified for use in future clinical trials, as well as identify information to inform the development of a conceptual framework or conceptual model.
Start with the end in mind: Development of an endpoint strategy from phase I to phase IV to ensure product differentiation at the time of market launch.
Leverage clinical trials to talk to patients about their experience to inform the measurement strategy and endpoint selection of future clinical studies.
Utilize survey research as a cost-effective and time-efficient means to collect information from large or hard-to-reach samples.
eCOA EQUIVALENCY TESTING
If a paper version of a clinical outcome assessment is migrated to an electronic format, additional testing of the electronic version may be needed to confirm that respondents interpret and respond similarly across versions.
Design regulatory and commercial communication strategies to secure labeling claims and enhanced market access position.