Strategic COA Alignment to Enable Regulatory and Access Success
Our goal
Patient experience evidence is increasingly required by regulators and payers — not just collected. The real challenge isn’t whether outcomes exist, but whether they are structured to support decisions.
At Hausler Consulting, we support development teams design and implement strategies to capture, analyze, and communicate these patient experiences. By aligning your development programs with regulatory and payer expectations, we reduce downstream evidence uncertainty and ensure your therapies demonstrate meaningful impact where it matters most — in the lives of patients.
Our services
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Gap Analysis of COA Strategy and Evidence
We conduct comprehensive gap analyses of Clinical Outcome Assessment (COA) strategies and evidence to evaluate the adequacy for regulatory submission and payer acceptance. Our expertise supports the identification and resolution of gaps in content validity, psychometric properties, and thresholds of meaningful change, thereby ensuring COAs are fit-for-purpose prior to their implementation in pivotal clinical trials.
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Understanding Patient Experience
As patient-centered evidence is more and more required by regulators as well as payors, it is key to understand the patient experience. We support you by defining concept(s) of interest by gathering insights through concept targeted literature reviews. Patient and expert interviews may be facilitaed and connducted by a third party.
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Identifying and Selecting Fit-For-Purpose COAs
We systematically identify and evaluate Clinical Outcome Assessments (COAs) to ensure alignment with the study’s target population, therapeutic area, and regulatory expectations. Potential COAs are identified through instrument targeted literature reviews and landscape assessments. Further, a structured mapping of COAs against the concepts of interest and intended clinical endpoints enable a clear assessment of their relevance and appropriateness. We further consider the evidentiary basis supporting COAs, including content validity, psychometric properties, cinical meaningful threshold, and feasibility of implementation, to inform the selection of the most suitable measures for clinical development and regulatory submission.
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![Medical writing or scientific writing for posters, abstracts or piublications as well as for evidence dossiers for regulatory purposes.]()
Medical Writing and Evidence Communication
Once you have all your COA-related evidence, we help you write publications or regulatory documents such as COA dossiers or support you with compiling presentations.
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Internal COA Training and Capability Building
We deliver tailored internal training programmes to strengthen organisational capabilities in patient-centred evidence generation. These sessions provide a structured introduction to patient experience data and Clinical Outcome Assessments (COAs), covering their role in drug development, the growing importance of patient-focused evidence in regulatory and reimbursement decision-making, and recent methodological and policy developments. Training is complemented by practical, real-world case studies to support application of concepts in ongoing and future development programmes.
About me
I am a COA strategy consultant with a background in epidemiology and pharmaceutical advisory, specialising in the strategic integration of Clinical Outcome Assessments (COA) within drug development programmes.
My experience includes working in large-scale evidence and access environments at IQVIA, where I contributed to projects spanning real-world evidence (RWE), HEOR, and market access strategy for global pharmaceutical clients. This foundation shapes my approach to aligning patient-relevant endpoints with regulatory and payer decision-making.
I focus on upstream COA strategy within clinical development — particularly during Phase II planning, Phase III design, and scientific or HTA advice preparation. My work centres on defining the concept of interest, structuring endpoint hierarchies, developing responder frameworks, and strengthening interpretability to ensure patient-relevant outcomes are positioned to support regulatory label claims and long-term access strategy.
Operating at the interface of clinical, regulatory, and commercial functions, I support development teams and consulting partners in embedding patient-relevant measurement into broader evidence and value strategy.
My objective is to ensure that patient-relevant endpoints are strategically structured to contribute meaningfully to regulatory success and sustainable market access.
Contact us
Let’s discuss how structured endpoint strategy can reduce downstream evidence risk.
Contact me for a 15-minute exchange?
Please write me an email to nadine.hausler@gmail.com and we’ll get back to you shortly.
We’re already looking forward to hearing from you.