Clinical Research Strategies, LLC
Haley Fuller, PhD is a Clinical and Regulatory Affairs Scientist II at Clinical Research Strategies, LLC. Prior to this, Haley held positions at the University of Pittsburgh Swanson School of Engineering and the Vaccine Production Program. Haley has a Doctor of Philosophy in Bioengineering and Biomedical Engineering from the University of Pittsburgh, and a Bachelor of Science in Biological Systems Engineering from Virginia Tech. Throughout their career, Haley has conducted research in the fields of synthetic biology, biomimetics, and cardiovascular bioengineering.
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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.