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Home : Leadership : Lynn Schaich Lynn SchaichLynn SchaichDescription of services: • QA/QC activities such as auditing clinical research studies and/or systems, QC of data and trial master files in preparation for NDA/BLA submissions • Managing clinical trials or projects from concept to integrated clinical study report(s) or submission • Co-monitoring or oversight of CRA activities • Authoring or revising SOPs • Training including GCP, clinical development processes relevant to specific needs • Medical writing for clinical projects Clinical Project Management • Protocol Design • Selecting and Managing CROs and Sites • Developing Data Standards, CRFs, and delivering data appropriate for database lock • Writing integrated clinical study reports Clinical QA/QC Auditing • Sites • Trial Master Files • Clinical Study Reports • Submissions Biography Lynn has over 20 years of biopharmaceutical industry experience and has been a consultant since 2005. She has a B.S. degree from Austin Peay State University and has worked for Vanderbilt University, A.H. Robins in Richmond, VA, and Solvay Pharmaceuticals, UCB, and Novartis Opthalmics (formerly Ciba Vision Ophthalmics) in the Atlanta area. She has comprehensive management experience and a solid track record of accomplishments. Some of her most significant achievements include • Creating and merging global SOPs for several international companies with process maps and templates. • Managing studies and participating in submission resulting in fastest approval time in FDA history for epilepsy NCE. • Establishing US QC group in clinical development with a variety of functions (QA/QC, archiving, clinical drug supply, training) with 10 direct reports. • Writing all clinical sections for two NDAs back to back in two years resulting in FDA approvals for pain and photophobia associated with corneal refractive surgery. Experience in Phases I-IV, and numerous therapeutic areas have resulted in proven strengths in IND/NDA compilation and management, protocol design and development, project management, study report generation, SOP and process development, and auditing for adherence to ICH GCP guidelines and applicable regulations. Excellent interpersonal skills will allow Lynn to work with your staff to achieve your objectives successfully.
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