Strategic Clinical Outcomes Assessment (COA) Consulting for Regulatory and Market Access Success
We support small and mid-sized biotech companies, emerging pharma, and CROs in designing and implementing 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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![Clinical Outcome Assessment (COA) strategy gap analysis supporting regulatory submissions and payer evidence requirements]()
Assessing COA Strategy and Evidence Gaps
We evaluate Clinical Outcome Assessment (COA) strategies and evidence packages to determine readiness for regulatory submissions and payer decision-making. Through targeted gap analyses, we identify limitations in content validity, psychometric properties, meaningful change thresholds, and endpoint alignment to ensure COAs are fit for purpose and support robust evidence generation.
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![Patient experience research informing concepts of interest and patient-centered evidence generation]()
Understanding Patient Experience and Concepts of Interest
We help development teams understand the patient experience and define meaningful concepts of interest that inform patient-centered evidence generation. Through targeted literature reviews and evidence synthesis, we identify symptoms, impacts, and treatment priorities relevant to patients. Patient and expert interviews can be facilitated through trusted partners when additional insights are needed.
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![Selection and evaluation of fit-for-purpose Clinical Outcome Assessments for clinical trials]()
Identifying Fit-For-Purpose Clinical Outcome Assessments
We identify and evaluate Clinical Outcome Assessments (COAs) that align with the target population, concepts of interest, clinical endpoints, and regulatory expectations. Through instrument-focused literature reviews and COA landscape assessments, we evaluate content validity, psychometric properties, meaningful change thresholds, and implementation feasibility to support fit-for-purpose COA selection.
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![Communicating patient-centered evidence through COA dossiers, publications, and regulatory documents]()
Communicating COA Evidence Effectively
We translate complex COA evidence into clear, decision-relevant communications for regulatory, payer, and scientific audiences. From COA dossiers and briefing documents to publications, abstracts, and presentations, we ensure patient-centered evidence is communicated effectively throughout the product lifecycle.
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![Clinical Outcome Assessment training for pharma and biotech teams on patient-focused drug development]()
Building Internal COA Capabilities
We deliver tailored training programmes to strengthen internal expertise in Clinical Outcome Assessments (COAs) and patient-focused drug development. Sessions cover regulatory expectations, methodological best practices, and practical applications of patient-centered evidence generation through real-world examples and interactive discussions.
About Hausler Consulting
At Hausler Consulting, we provide specialised Clinical Outcomes Assessment (COA) consulting to small and mid-sized biotech companies, emerging pharma organisations, and CROs seeking flexible, senior-level expertise in patient-centered evidence generation.
We support clinical development teams in designing and implementing COA strategies that generate meaningful evidence for regulatory submissions, market access, and payer decision-making. By integrating the patient perspective into drug development, we help reduce evidence uncertainty and ensure clinical outcomes align with the needs of regulators, payers, clinicians, and patients.
Behind Hausler Consulting is Nadine Häusler, a Clinical Outcomes Assessment specialist with a background in epidemiology, public health, and real-world evidence. Over the past decade, she has supported global development programmes across the product lifecycle—from early development through Phase III studies and regulatory submissions.
We understand that many biotech companies do not have dedicated in-house COA expertise. That's why we offer flexible, tailored support that provides direct access to senior-level expertise without the overhead of a large consultancy.
Our experience spans a broad range of therapeutic areas, including dermatology, respiratory, rheumatology, rare and neurological disorders, infectious and gastrointestinal diseases, cardiovascular and metabolic conditions, oncology, renal diseases, immunology and inflammation, and hematology.
We partner closely with cross-functional teams to develop patient-centered evidence strategies that strengthen clinical development programmes, support regulatory and market access objectives, and demonstrate meaningful treatment benefit where it matters most—in the lives of patients.
Nadine Häusler, PhD
At A Glance
PhD in Epidemiology & Biostatistics
10+ years of healthcare research and consulting experience
Former IQVIA Patient-Centered Solutions consultant
Expertise across 10+ therapeutic areas
FDA- and EMA-aligned COA strategies
Flexible support for biotech, pharma, and CRO teams
Let’s discuss your COA strategy
Whether you are preparing for a clinical trial, evaluating endpoints, or exploring patient-centered evidence needs, we would be happy to discuss how we can support your team.
Write me an email to nadine.hausler@gmail.com or schedule an introductory call