Strategic Clinical Outcomes Assessment (COA) Consulting for Regulatory and Market Access Success
We design and implement COA strategies, patient-reported outcomes (PROs), and endpoint frameworks aligned with FDA and EMA requirements.
Our goal
Patient experience evidence is increasingly required by regulators such as the U.S. Food and Drug Administration and the European Medicines Agency, as well as by payers — not just collected, but structured to support regulatory and reimbursement decisions. In modern drug development, the challenge is no longer whether clinical outcomes or patient-reported outcomes (PROs) exist, but whether clinical outcome assessments (COAs) are designed to generate robust, decision-relevant evidence.
At Hausler Consulting, we support pharma and biotech development teams in designing and implementing COA strategies that systematically capture, analyze, and communicate patient experience data. Our expertise spans patient-focused drug development (PFDD), endpoint selection, and COA validation, ensuring alignment with FDA and EMA guidance.
By integrating patient-centered evidence into your clinical development programs, we reduce downstream evidence uncertainty, strengthen regulatory submissions, and support payer acceptance. This ensures your therapies demonstrate meaningful, measurable impact where it matters most — in the lives of patients.
Our services
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COA Strategy and Gap analyses
Expert COA strategy and gap analysis for pharma and biotech. Ensure your clinical outcomes assessments meet FDA and EMA requirements and support regulatory and payer decisions.
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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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![We partner with you to capture the patient experience in clinical trials, make sure the patient-reported outcome measures are according to FDA and EMA regulatory requirements, and demonstrate value for HTA agencies ensuring patient access.]()
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.