The judicious balancing of scientific and corporate considerations is a key part of Medical Affairs for all products. This is accomplished by keeping sight of the overall goals of the project while dealing with the day-to-day medical issues and decisions that make up the individual steps involved. WinPharm's experience with the product approval process, as well as supporting the needs of marketed products, allows this critical perspective to be added regularly to early stage projects. Protocol design and development Therapeutic target selection Expert consultant identification and interaction Statistical considerations for protocol design Medical monitoring and pharmacovigilance Serious Adverse Event investigation and reporting Interim data review Medical writing Final study reports and scientific manuscripts Literature reviews Competitive reviews Investigator Brochure Advisory Board creation and management Independent Data Safety and Monitoring Boards Regulatory Pre-IND packages and meetings IND development, submission and maintenance End-of-Phase 2 packages and meetings

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