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 and develop clinical outcome assessments relevant to patients
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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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Capture patient-reported symptoms, adverse event burden, and disease impacts
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Understand the clinically meaningful change from the patient’s perspective
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Ensure a positive benefit-risk profile by measuring patient tolerance of key treatment side effects
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3.
REGULATORY
SUBMISSION
Patient risk tolerance and relevance of a benefit
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Support favourable benefit-risk assessment
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Contextualise patient-reported outcomes for successful label claims
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4.
POST-MARKETING
(reimbursement and
commercialisation)
Demonstrate treatment value in the real world
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Incorporate patient perspective 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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Measure patient-reported treatment impact in the real world