Translating patient insights into evidence that matters
Our goal
Understanding the patient perspective is critical to the success of today’s medical innovations. Regulators, payers, and healthcare providers increasingly expect evidence on how treatments affect not just clinical outcomes, but also symptoms, daily functioning, and quality of life. At Hausler Consulting, we support medical product developers design and implement strategies to capture, analyze, and communicate these patient experiences. By aligning your development programs with regulatory and payer expectations, we 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.
About me
I’m Nadine Häusler, PhD, a consultant specialising in patient-centred evidence strategies for biotech, medtech, and CRO partners.
With over ten years of experience in epidemiology, biostatistics, and real-world evidence, I help teams design and implement Clinical Outcomes Assessment (COA) and patient-centred evidence strategies that align with regulatory and payer expectations. My work has contributed to successful FDA and EMA submissions, optimised clinical trial designs, and strengthened product value communication.
Before starting my independent practice, I worked at IQVIA, supporting global clients in integrating patient experience data into clinical development. Earlier in my career, I led academic research in epidemiology and biostatistics at the University Hospital Lausanne and University of Zurich, publishing several peer-reviewed studies.
I’m passionate about translating complex data into clear, actionable insights — helping companies bring meaningful, patient-focused innovation to market with scientific rigour and purpose.
Contact us
Are you interested in working together?
Please write me an email to nadine.hausler@gmail.com and we’l get back to you shortly.
We’re already looking forward to hearing from you.