Medical Affairs

 

• Establish and maintain medical affairs and pharmacovigilance function
• Publication strategy and planning
• KOL identification and interaction, including organizing AdBoards, Expert panels, etc.
• Data/product presentations and slide preparation
• Medical life cycle management
• Medical Monitoring

Epstein Associates arranges for experienced physicians to provide specific DSMB needs.  Medical monitoring services consists of a 24 hour clinical study monitor that would be available for both the U.S. and internationally.  Oversight of studies that are multi-center and multi-site.  Support services include paging, faxed reports, e-reports and conferencing.  Epstein Associates is capable in the areas of IRB interface, SAE Adjudication, SUSAR Reporting (Suspected Unexpected Adverse Reaction), Pharmacovigilance, Active Query and MedDra.  We can also organize and manage DSMB (Dta Safety Monitoring  Board).