Menu
Leverage evidence synthesis to understand the existing landscape and emerging trends for strategic planning and market positioning. Evidence synthesis is crucial to uncovering evidence gaps and prioritizing research to support product value story development.
Services Include:
Real-world evidence (RWE) is instrumental for life sciences companies in shaping their drug development strategies, demonstrating the value of their products, and understanding how interventions perform in real-world clinical practice. Leverage insights from RWE to support regulatory submissions and post-market monitoring requirements and provide payers with the necessary information to make coverage and reimbursement decisions
Services Include:
Economic modeling is an integral part of the life sciences industry, supporting decision-making at various stages of drug development, market access, and post-market activities. These models provide a systematic and quantitative approach to demonstrating the economic value of healthcare interventions and are crucial for navigating the complex landscape of healthcare reimbursement and access.
Services Include:
RWE can provide insights into the natural history and prevalence of a disease, treatment patterns, and patient characteristics. This information helps in designing more realistic and relevant clinical trials, including selecting appropriate eligibility requirements and endpoints, supporting protocol development, and identifying appropriate comparator arms. Additionally, RWE supports the identification and data capture for external control arms in trials.
Expert opinion can be a powerful tool, particularly in formulary decisions and clinician adoption. Leverage the strategic guidance and insights from external experts for guidance on:
Support analysis and publication strategy through medical writing support. Our seasoned team balances scientific accuracy with clarity and adapts to various audiences.
Services Include:
© Health Clarity Solutions, Privacy Policy, All Rights Reserved 2024
Joe is an accomplished healthcare executive with a track-record of bringing innovative technologies to market and helping client organizations develop and execute digital health strategies. A common thread throughout his career is a passion for translational data science – the “bench to bedside” operationalization of evidence-based insights and data driven technologies.
Joe has extensive experience in health informatics research, including predictive model development, clinical trial design, and process and outcomes improvement. He has published widely and received research awards from the American Medical Informatics Association, the Society of Critical Care Medicine, and the Journal of Biomedical Informatics. He worked closely with the FDA on one of the first real-world evidence supported regulatory clearances for AI/ML software used in predicting patient deterioration. Joe has led US and European federal grant projects, most recently as co-principal investigator on a contract from the US Department of Health and Human Services Biomedical Advanced Research and Development Authority to develop and deploy an Emergency Department triage tool.
In a prior role as CEO of PeraHealth, Joe expanded the company’s focus to encompass health care delivery challenges across the care continuum, including in sub-acute and home health environments and he oversaw the transformation of the company’s analytics service offerings in these areas. Following the acquisition of PeraHealth by Spacelabs Healthcare, Joe led Spacelab’s data science and analytics strategy, spear-heading the company’s digital health and analytics roadmap. Joe is a long-time proponent of the concept of augmented intelligence in healthcare – the operationalization of innovative AI/ML technologies which can both enhance the effectiveness and improve the experience of clinical care providers.
Kathy is a clinical informaticist, data scientist and healthcare technologist with over 25 years of experience conducting healthcare research and performance improvement initiatives.
She has a passion to transform healthcare through data-driven care redesign and a diverse background enabling her to balance innovative strategy with rigorous scientific methodologies to create fit-for-purpose solutions.
She has extensive experience leading data-driven projects for pharmaceutical, biotech, medical device companies, health service providers as well as specialty societies and government agencies. Her work includes both traditional and innovative study designs across a wide range of topics and clinical areas and has resulted in more than 100 peer-reviewed publications and/or presentations in scientific journals and conferences.
Kathy has extensive data collection and linkage experience across many types of healthcare datasets including two used by the U.S. Food and Drug Administration, for which she was a subject matter expert. In a prior role with Premier, Inc., she served as data expert and lead scientist for an innovative pay-for-performance demonstration project with the Centers for Medicare & Medicaid Services. More recently she has led a range of data science, analytics and clinical technology initiatives for effective development and deployment of clinical decision support technology.