MD

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)


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