Project Management

• Study protocol and design
• Budget and project timelines
• Resource management and project staff
• Development of project specific study materials, documentation and newsletters
• Development of project specific Standard Operating Procedures
• Site assessment/qualification
• Site and investigator selection
• National and international regulatory submissions, including ongoing correspondence and regulatory reporting requirements
• National and international Ethics Committee submissions including ongoing correspondence and reporting requirements
• Regulatory document collection, review and approval
• Review and approval of monitoring reports
• Preparation of project specific reports
• Event management (investigator meetings, update meetings and trial presentations)
• Archiving plans