Guidance and Consultancy
We partner with you to build robust patient experience data that demonstrates meaningful treatment benefits beyond conventional clinical measures. Our experienced team of scientific experts understand how to optimize your patient-focused drug development strategy for enhanced regulatory outcomes and strategic decision-making.
Better outcomes start with patient insights
Patient experience data is the foundation of successful drug development. We guide you through every stage of the research process to optimize the design and impact of your patient experience data for regulatory submission. We help you discover competitive advantage by differentiating products with compelling patient perspectives—to support stronger labelling claims, premium pricing strategies, and patient-centric commercial messaging, backed by regulatory-standard evidence.
Our consultancy approach covers all scientific and operational aspects. For example, we can help you identify relevant concepts of interest to develop your COA strategy based on primary or secondary research (e.g. targeted literature reviews, COA competitive landscape reviews, gap analysis, SWOT analysis, patient and clinician interviews and conceptual model development).
Our experienced team of industry professionals help you develop the most valuable patient insights—for better regulatory outcomes.
Comprehensive consultancy services for
patient-focused drug development
Clinical Outcome Assessment (COA) evaluation and strategy
Conduct cognitive debriefing and validation studies
COA landscape review, gap analysis, SWOT analysis and psychometric evaluations
Select, modify, or develop fit-for-purpose patient-reported outcome measures (PROMs)
Establish meaningful change thresholds through patient input
Advise on clinician-reported and observer-reported outcome measures
Study design & data collection
Partner with clients to define clear objectives and research methods
Expert guidance to sample for sub-group analysis and data saturation
Develop concept elicitation studies to understand patient experiences
Apply qualitative insights to inform quantitative methodologies to meet regulatory standards, e.g., to understand meaningful change
Data analysis & documentation
Systematic analysis of patient interviews and focus groups
Thematic analysis and concept mapping from patient narratives
Integration of patient voice data with clinical trial outcomes
Conceptual model development based on primary or secondary qualitative patient/caregiver research
Cross-study comparisons and meta-analyses of patient experience data
Strategic planning & regulatory intelligence
Patient experience data collection strategies aligned with FDA's Patient-Focused Drug Development (PFDD) guidance series
Navigation of the four-guidance framework covering sampling, data collection, submission, and clinical outcome assessments
Knowledge of regulatory precedents and successful submission examples
Compliance with both FDA and EMA patient engagement requirements
Patient voice strategies aligned with specific therapeutic area requirements
Regulatory documentation and preparation
Preparation of patient experience data for regulatory submissions, e.g., data summaries, formatted documentation, strategic planning for meetings and data inquiries.
Development of comprehensive patient voice narratives for benefit-risk assessments
Support during pre-submission meetings and advisory committee preparations
Post-meeting follow-up and implementation of FDA feedback
Regulatory submission services
Integration of patient experience data into New Drug Applications and marketing applications
Preparation of patient experience data tables and summaries
Cross-referencing patient data with clinical efficacy and safety outcomes
Support for labelling discussions incorporating patient perspectives
Alignment of patient experience data across FDA, EMA, and other global authorities
Patient experience data for regulatory submissions
Listen to our chief scientific officer, Anna Ryden (PhD), explain how patient interview data can support regulatory submissions and labeling claims.
From patient insights to
drug approvals
We partner with you to build robust patient voice evidence that demonstrates meaningful treatment benefits beyond conventional clinical measures. Our high-quality documentation addresses regulatory expectations for patient-centered data. We mitigate submission risks through expert compliance guidance.
Talk to our team of experts
For comprehensive patient-focused drug development consultancy.
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