Clinical Research Strategies, LLC
Kaysie Foust is a seasoned professional in clinical quality and regulatory analysis, currently serving as a Senior Clinical Quality Specialist and Auditor at Clinical Research Strategies, LLC since January 2023. Prior experience includes roles such as Quality and Regulatory Analyst focusing on Post-Market Surveillance at ALung Technologies, Specialty Laboratory Technologist at UPMC Genome Center, and Senior Laboratory Technician at Interpace Diagnostics, among others. Kaysie possesses extensive experience in laboratory operations, including whole genome sequencing, quality assurance, and analytical testing in compliance with cGMP standards. Kaysie earned a Bachelor's degree in Biochemistry and Molecular Biology from Penn State University.
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Clinical Research Strategies, LLC
Pittsburgh’s Premier Boutique Start-up CRO Partner | Clinical Research and Regulatory Strategy Management | CRO Due Diligence and Management | Trial Rescue | Executive Management Consultancy for Life Sciences Assist new companies and life science/healthcare IT entrepreneurs with corporate start-up. Distill the complexities of regulatory and research disciplines into accessible terms for life science executives, entrepreneurs, and investors alike, who play a pivotal role in the development and investment of a new product, to improve its chances of clearing performance hurdles toward successful commercialization or exit. Customize materials and presentations that offer a fundamental understanding of research from clinical study protocol development with statistical approach, costing and budgeting, site selection, study management, patient recruitment and outcomes, regulatory strategy, approvals, and reporting, risk management, reimbursement, publication, market adoption, and change to clinical practice guidelines. Specialties: corporation start-up and compliance, risk mitigation and assessments, clinical trial performance, CRO due diligence/selection/management, eTMF management and inspection-readiness, QA/audit for inspection-readiness; regulatory pathways, and ROI; assistance with due diligence; and, turnaround clinical trials and partnerships.