S Greenberg Statistical Consulting

S. Greenberg Statistical Consulting Inc. provides statistical consulting in all aspects of clinical drug development including: bullet Clinical Development Plans: strategy, design, methodology, and sample sizes bullet Clinical trial design & protocol development, including: bullet Study designs, statistical methodology, sample sizes, protocol stati... stical sections, & randomizations bullet Providing statistical advice to Executive and Steering Committees bullet Interfacing with Clinical Event Committees bullet Interfacing with Data Safety & Monitoring Committees bullet CRO selection & oversight of statistics & data management functions bullet ARO selection, interface, & oversight bullet CRF/eCRF development bullet IVRS selection and management bullet Preparing and/or reviewing Statistical Analysis Plans bullet Preparing statistical analyses, interpretation, reports, & publications bullet Design, implementation, & analysis of cardiovascular mega-trials bullet Performing due diligence for Licensing & Acquisitions bullet Assisting start-up companies in preparing for Due Diligence reviews bullet Regulatory agency interactions, including: bullet Preparation for & attendance at meetings with regulatory agencies bullet Preparing and/or reviewing regulatory dossiers bullet Preparing and/or reviewing responses to regulatory agency questions bullet Preparation for FDA Advisory Committee Meetings bullet Providing support at FDA Advisory Committee Meetings bullet Performing vendor audits (CROs, AROs, IVRS vendors, etc.) bullet Biometrics management & infrastructure development bullet Commercial and Business Development support bullet Providing general statistical support for start-up companies The principal, Dr. Sally Greenberg, has over 28 years of pharmaceutical and biotechnology industry experience, including 24 years of experience working on Phase I-IV cardiovascular and cerebrovascular clinical trials. She also has 21 years of management experience, most recently being VP of Biometrics and Clinical Data Management at ...Read More