• Clinical development planning
• Budget forecasting and analysis
• Due diligence evaluations
• Clinical operations administration:

      system analysis and development
• Clinical SOP development
• CRO selection:

      RFP preparation and budget negotiation
• Protocol development

 

      Review data management and biostat plans
• Central laboratory selection:

      Specification and contract development
• Clinical site audits
• Clinical monitoring
• Data review and medical writing:

      Table, Listing, Figure review,

      Clinical Study Report preparation