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MD
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M
Discovery and New Business Development
• New Molecular Entities
• New Applications for Existing Molecular Entities
• In-licensing/Out-licensing Prospect Identification
• Due Diligence
Regulatory Affairs
• Strategic Planning for pre-IND Meetings and Submissions
• IND/NDA Preparation and Submission
• Liaison with Regulatory Authorities
• Strategic Planning and Client Representation for
MD Regulatory Meetings
Clinical Research
• Clinical Development Programs
• Study Design and Protocol Preparation
• Identify and Qualify Clinical Study Sites and Site Personnel
• IRB Submissions
• Investigator Meetings
• Perform Initiation, Monitoring and Closeout Visits
• Develop and Maintain Investigator Study Files
• Patient Recruitment Tracking, Analysis and Enhancement
• Investigator Contract Negotiations and Grant Management
• Study Report Medical Writing
Project Management
• Interdisciplinary Strategies for Development Projects
• Resource Allocation
• Central Contact for all Project Team Members
• Tracks Progress Toward, and Achievement of,
MD Decision-Point Milestones
Advisory Boards
• Scientific/Clinical Development
• Pre-Clinical Advisory Boards
• Early Clinical Evaluation Boards
• Safety Review Panels
Publication/Professional Education Strategies
• Pre-Clinical and Clinical Publications
MD (journal selection and manuscript preparation)
• Abstract preparation and presentation for national
MD professional society meetings
• Speakers Bureau (selection, training, media preparation)
© Magidom Discovery, LLC, 2005. All Rights Reserved.
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