We bring decision-relevant patient voice to all stages of drug development
1.
PRECLINICAL
DEVELOPMENT
Product design and prioritisation
Product design and prioritisation
Product design and prioritisation
Product design and prioritisation
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Establish experience with currently available treatments
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Understand unmet medical needs
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Identify potential target concepts and matching clinical outcome assessments​
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Develop conceptual models with targeted concepts
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2.
CLINICAL
DEVELOPMENT
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Strategies for a meaningful integration of the patient’s voice
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Inform clinical trial design by prioritisation of outcome measures and patient-informed protocol design
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Understand the treatment burden of competing treatments
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Ensure a favourable benefit-risk profile by measuring patient tolerance of key treatment side effects
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Assess product and trial experience through patient and site interviews
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Understand the clinically meaningful change from the patient’s perspective
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Prepare COA meetings with FDA COA Science team and COA briefing dossiers for COA label claims
3.
REGULATORY
SUBMISSION
Patient risk tolerance and relevance of a benefit
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Provide support with benefit-risk assessments
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Support client strategy for FDA discussions regarding patient-reported outcomes label claims
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Bring the patient voice to regulatory interactions​
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4.
POST-MARKETING
(reimbursement and
commercialisation)
Demonstrate treatment value in the real world
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Incorporate patient perspectives and preferences into reimbursement submissions
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Demonstrate patient preference for key treatment attributes to clinicians and other stakeholders
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Identify barriers and facilitators leading to product uptake
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