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FDA’s Expanded Integration of Patient Preference Information: A New Standard in Patient-Centred Regulation
The U.S. Food and Drug Administration (FDA) is setting a new standard for patient-centred care with its recently updated draft guidance...
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Life Science
Pharmaceutical
Biotechnology
Medical Devices
We deliver end to end HEOR research projects from conception to dissemination
We deliver patient focused health economic, preference and outcomes research that can support:
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Strategy and product development
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Patient experiences and preferences
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Health economic modelling (quality of life, economic cost and more)
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Characterising disease burden and unmet need
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Engagement and communication with key stakeholders
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Scientific and medical communications
With extensive experience supporting products across pharmaceuticals, biotechnology and medical devices we can provide a trusted end to end research unit to partner with for your evidence needs.
How we partner with you
We are specialists in evidence generation via preference research, real world evidence & outcomes research but our team of health economists can provide a wide set of capabilities to support your research needs.
Preference Research Top
Preference Research
Our team has extensive experience conducting qualitative and quantitative preference research. We combine approaches to deliver mixed methods studies. We suggest the best approach based on the research need.
Preference Exploration
Exploration methods are qualitative and aim to gather descriptive data through participant observation and subjective experiences. These methods help to understand the underlying reasons and motivations behind patient preferences.
Individual Methods
Semi-Structured Interviews
Structured Interviews
In-Depth Interviews
Group Methods:
Delphi Panels
Focus Groups
Nominal Group Technique
Preference Elicitation
Elicitation methods are quantitative, collecting data that can be statistically analysed to test hypotheses and draw generalizable conclusions.
Discrete Choice and Ranking Methods
Discrete Choice Experiment
Conjoint Analysis
Best-worst Scaling
Indifference Methods
Time trade-off
Standard Gamble
Threshold Technique
Rating Methods
Visual Analog Scale
Swing Weighting
Allocation of Points
Real World Evidence & Outcomes Research
RWE and Outcomes Anchor
We provide evidence generation via primary data collection methods or gather and analyse existing data from secondary sources using data science and statistical analysis techniques.
Primary
Data Collection
Patient Generated Data
Data generated directly by patients or their carers including from wearable, medical or personal devices, mobile apps, social media, and other internet-based tools. Patient reported outcomes measures can be used to gather PGD.
Data can be collected via cross-sectional, retrospective, prospective and longitudinal studies.
Chart Reviews
Data extracted retrospectively from a review of patient health records (including paper or electronic records).
Particularly valuable in studies of rare diseases to model natural history.
Secondary
Data Collection
Electronic Medical Records
Computerised individual patient record. These are typically used to inform the clinical management of patients.
Claims and Admin Data
Data collected for administrative purposes by insurance companies and health services.
Patient Registries
Registries are organised systems that collect data to identify specified outcomes for a defined disease population.
Digital, Ethics and Data Governance
Digital Tech Anchor
Digital
Our team are experts in designing digital solutions including remote data collection technologies, engaging hard to reach populations..
Solutions are built in-house, resulting in effective communication and transfer of context from the research team to the development team:
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Online Research Portals
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Mobile and web applications
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Wearable technologies
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And more
Ethics
We have strong connections with academic, national and international Research Ethics Committees (RECs), and Institutional Review Boards (IRBs) in several countries. We lead:
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Ethics Applications
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Ethics Exemption Determinations
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Ethics Guidance and Support
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REC attendance
Data Governance
Our team has experience handling sensitive data, implementing and governing information management systems and data management plans.
We can develop:
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Data Management Plans
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Data Flow Maps
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Studies integrating privacy enhancing technologies (e.g. tokenization and others).
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Standard Operating Procedures
Additional Capabilities
Additonal Capabilities Anchor
We are specialists in preference research, real world evidence and HEOR research but our team of health economists have wide set of capabilities, therefore we can support many research needs. See below.
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