Our Services

We focus on endpoints and outcomes for clinical trials.

And that is all we do.

DEVELOPMENT

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.

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VALIDATION

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.

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REGULATORY STRATEGY

Help navigate communication with regulatory authorities, including when and what to communicate.

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LITERATURE REVIEWS

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.

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ENDPOINT STRATEGY

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.

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DELPHI PANELS

Gain expert consensus in an area of interest such as patient-reported outcome (PRO) item selection, developing screening tools, or establishing treatment patterns.

EXIT INTERVIEWS

Leverage clinical trials to talk to patients about their experience to inform the measurement strategy and endpoint selection of future clinical studies.

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SURVEY RESEARCH

Utilize survey research as a cost-effective and time-efficient means to collect information from large or hard-to-reach samples.

NATURAL HISTORY STUDIES

Examine the course of a disease from its inception through all of its clinical stages via survey and/or interview research.

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.

COMMUNICATION STRATEGY

Design regulatory and commercial communication strategies to secure labeling claims and enhanced market access position.

GAP ANALYSIS

Determine what needs to be done and when to meet regulatory and market access requirements around trial endpoints.