Project management

• Coordination and control of the project and contractors such as test product manufacturers, external monitors, coordination centers abroad, etc.
• Risk, change and interface management
• Planning, coordination, review, error analysis and continuous optimization of project processes
• Contract, time and budget control
• Creation and revision of central documents such as the project plan
• Document management (maintaining the trial master file)

Monitoring and trial site management

• Regulatory preparation of a trial center (required documents, requirements for trial site, etc.)
• Preparation of trial site documentation (Trial Investigator File/ Investigator Site File)
• Pre-study and initiation visits
• Periodic monitoring (in-house and onsite) including source data reconciliation according to monitoring plan; close-out visits
• Support of investigator sites
• Communications with the trial sites