What we do / Patient-centered outcomes
Integrated Evidence Generation Planning: Driving Successful Reimbursement and Life Cycle Management
Webinars•HEOR & market access, Market access strategy, Patient-centered outcomes
We have the unique ability to bring together experts in patient centered outcomes and engagement to solve complex challenges
Our technical and strategic capabilities can support your team in developing patient-reported outcomes instruments and clinical outcomes assessments, as well as in assisting in trial selection and creating patient-support programs. This allows us to be your strategic partner through the entire product lifecycle from pre-clinical to post-approval – from scientific to commercial.
Pre-Clinical Development
Understand the condition
- Develop a strategy for patient engagement and PRO measurement throughout the drug development process
- Characterize burden of illness and unmet need
Phase 1/2 Clinical
Optimize study design
- Identify measures and if not fit for purpose, begin developing evidence
- Optimize trial design to capture endpoints that matter to patients
Phase 3 Clinical
Measure holistically
- Constant assessment of design to ensure right data collected right way at the right time
- Determine patient benefit / risk trade off in treatment valuation
Regulatory/HTA
Demonstrate Value
- Patient advocacy group partnerships
- Analyze utilities for economic modeling
- Strategic support PRO / COA experts
- Consider secondary analysis of trial data
Commercialization / Real-World
Improve access and uptake
- Primary data collection studies
- Preference studies vs. other treatments
- Partnerships with advocacy groups
- Qualitative assessments and social listening to inform design of patient assistance and patient support programs
Dynamic partnership with patients and their advocates throughout the entire process
What we do
PRO/COA Psychometrics, Data Analytics, & Strategy
Working to optimize COA measurement within clinical trial settings
- Strategy: Endpoint & Regulatory advising
- Endpoint Development: Core Psychometrics (modern and classical methods)
- Optimizing Efficacy: Trial Diagnostics and Trial Rescue
- Subject and Site effects: Influence diagnostics
- Errors in Randomization: Adjusting for Post-Randomization Imbalance
- Unobserved heterogeneity: Latent Class Models
- Biostatistics Applications
- Linear/Generalized linear (mixed) models
- Survival models
- Missing Data Solutions: Joint Model & Pattern-Mixture
Qualitative Research
Capturing the patient’s voice to inform development of new instruments and understand the patient experience
- COA Development/Content Validation: Concept Elicitation, Item Generation, Cognitive Interviews
- Regulatory (FDA) Communications Support: focused on Content Validity of COAs and COA Qualification
- Exploratory qualitative studies: To characterize treatment experiences
- Patient Journey studies
- In-trial and Exit Interview studies
- Patient-Public Involvement (PPI) studies
- Qualitative research as part of wider mixed methods studies
- Literature reviews with qualitative analysis component
Preferences & Utilities
Capturing health-related quality of life and the value interventions bring in a quantitative manner
- Discrete Choice Experiments: Benefit-risk assessment, utility assessment, willingness to pay, regulatory or payer decision-making frameworks
- Utilities: utility elicitation using existing instruments (e.g., EQ-5D) and direct elicitation methods such as time-trade-off, utility mapping, strategy development and generation of utilities for use in cost-utility modeling
- Personalized Utility Function: efficient and compositional preference elicitation, allowing to define a value function on the individual level
- Q-TWiST analysis: Quality-adjusted Time Without Symptoms of disease and Toxicity
Decision Sciences
Quantifying the processes used to synthesize data for healthcare decisions
- Quantitative Benefit Risk Assessment (qBRA) using
- Multi Criteria Decision Analyses (MCDA)
- Shared Decision Making (SDM)
- Delphi panels
Real-World Patient-Centered Studies
Understanding patient outcomes in a real-world setting to support market access and improve uptake
- Quantitative surveys (patient, caregiver, HCP)
- Mixed methods studies
- PRO/HEOR strategy
- PRO/HEOR Trial Analyses
- Landscape Assessments and trial endpoint reviews
Latest authored publications
Our researchers publish numerous peer-reviewed articles and poster presentations each year across a variety of noteworthy journals and conferences. Take a look at our latest publications or search through historical publications by journal, date, or therapeutic area.
Forming the best end-to-end global patient-focused consultancy – together
Active patient collaboration supports our clients through all areas of research.
Real-world evidence & data analytics
- Incorporate custom or validated instruments to understand real-world outcomes
- Qualitative research to characterize patient experience
Market access strategy
- Patient journey provides context in dossiers
- Patient perspective / participation in drug development and approval process increasingly valued and required by regulatory bodies worldwide
Health economic modeling & meta-analysis
- Patient journey can help to inform core health states
- Preference research leading to utilities for key health states
Striving to become more patient-centric?
Let’s explore together
We will demonstrate how patient-centricity can be integrated into all phases of development and commercialization and provide examples of how to achieve patient buy-in and ensure the patient voice is represented in your study outcomes.
Digital tools can enrich the patient journey
Our experts have the experience needed to guide you to the right digital tool that can be used to enhance data collection.
Bespoke patient emotional journey research
Virtual ad boards, webinars and symposia
Data collection tools
Simple digital platforms for data collection and immediate analysis
Why us?
Our scientific and patient engagement experts are actively involved in the patient-centered outcomes research field. We have the experience needed to guide you to solutions that incorporate the patient’s voice.
85
Active Projects
2
FDA-Funded Grants for PCO Development
60
PCO Publications
Get in touch
To learn more about our patient centered outcomes research and discuss what we could do for you, please get in touch.
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