Clinical Research Strategies, LLC
Alyssa Harris, MS, is currently the Manager of Clinical and Regulatory Affairs at Clinical Research Strategies, LLC. Prior to this role, Alyssa worked as a Project Manager at UPMC, overseeing the NANO Trial. Their previous experience includes roles as a Health and Fitness Specialist at the University of Pittsburgh and a Research Assistant at Children's Hospital of Pittsburgh. Alyssa holds a Master's degree in Health and Physical Activity and Chronic Disease from the University of Pittsburgh.
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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.