Clinical Research Strategies, LLC
Sheila Grab is a Clinical Research Specialist at Carmell Therapeutics since December 2018, where Sheila is involved in the clinical trial strategy and development for pivotal trials in the US and internationally. Sheila is also an Associate Project Manager and Medical Writer at Clinical Research Strategies since July 2019, managing clinical research projects and ensuring compliance with trial regulations. Sheila previously worked as a Clinical Research Associate at SCOPE International USA, Inc. and held various research roles at Magee-Womens Research Institute and Foundation. Sheila holds a Bachelor of Science degree from Penn State University with a minor in Spanish and is currently pursuing further education at Universitat d'Alacant.
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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.