START-UP ACTIVITIES
- Preparation of operational and project plans
- Preparation of study related and essential documents
- Study sites identification, assessment and selection
- Database implementation
REGULATORY AFFAIRS
- Preparation of regulatory dossiers for submission to Ethics Committees and regulatory agencies
- Follow-up and finalization of submissions for approval
- Sites coordination for Regulatory approvals
- Clinical Trial Agreement negotiation and finalization
PROJECT MANAGEMENT
- Implement the operational and project plans
- Patient recruitment according to milestones
- Ensuring quality data entry in database
- Managing IMP and study material supply
- Clinical monitoring activities
SITE MANAGEMENT
- Training on study for study staff
- Site Initiation Visits
- Ensure maintenance of study documentations on sites
- Safety event reconciliation, coordination and management
- Quality management
STUDY CLOSE-OUT
- Preparation of final clinical trial reports
- Close out visits
- Study archiving management
- Inspections and audits preparation
- Assistance in final results analysis and presentation
OTHER ACTIVITIES
- Management of contractual aspects
- Management of financial aspects
- Obtaining local insurances
- Quality assurance and control
- Vendor management
