Evidera’s outcomes researchers represent a unique combination of scientific disciplines, including psychometrics, epidemiology, biostatistics, psychology and public health. We develop and evaluate clinical outcome assessments to support labeling and promotional claims. We are your partner for evaluating patient, clinician, caregiver and performance outcomes, utilities and preferences, adherence and other customized prospective observational study needs.
Evidera designs and implements strategies for outcome evaluation, including clinician-reported outcomes (ClinRO), patient-reported outcomes (PRO), observer/caregiver-reported outcomes (ObsRO) and/or performance outcomes/tests (PerfO) that meet regulatory and stakeholder demands. We take an evidence-based approach to instrument development, driven by extensive experience measuring health outcomes across a variety of conditions and diseases. We help you understand the issues and design your program from concept identification and development through platform selection, instrument design and psychometric testing, and we provide ongoing support during implementation and analyses.
With Evidera as your partner, you get a team of leading scientists who have developed innovative methods and instruments that are rapidly adopted by the field. For example, Evidera:
Develop strategies to enhance ClinRO, PRO, ObsRO and PerfO from concept identification through psychometric evaluation and dissemination.
Discuss the strengths and limitations of your product or portfolio, identify outcomes with measurable value, establish research goals, prepare a plan for goal achievement and guide the plan to a successful conclusion. Develop focused and customizable training programs, which can be a valuable component in achieving these goals.
Enhance your regulatory positioning with a carefully compiled dossier of evidence delineating the precision of your product’s key outcome measures.
Obtain health state utility valuations (time trade-off and standard gamble), consultation on inputs for cost-utility modeling, the development of condition-specific preference-based measures, and mapping to generic preference-based measures.
Support trial design, Clinical Outcomes Assessment (COA) strategies, patient engagement, statistical analysis plans, results interpretation and reports.
Evaluate mode selection and conduct cognitive interview/usability and equivalence studies for electronic instrument development.
Conduct in-depth statistical analyses, including Rasch and item response theory (IRT) methods and advanced psychometric methods as well as advanced statistical modeling such as latent growth curve analysis, mixture models and structural equation models.
Inform your outcomes research strategy from trial design to communication with regulatory agencies.
Plan and execute outcomes research dissemination strategies from inception to completion.