PROJECT MANAGEMENT
Monitor time, cost & quality
Coordinate team, customer & vendor communications
Risk management Provide training
STUDY DESIGN
& BIOSTATISTICS
Design and protocol writing
CRF design Statistical analysis
Final report
STUDY
START-UP
Feasibility
Site selection
REGULATORY
AFFAIRS
Submissions to ECs/Regulatory Authorities
Meetings with Regulatory Authorities
STUDY
MONITORING
Site management
Monitoring
OUTSOURCING
Individual professionals or project teams
Short/long-term
Wide range of experiences and positions
INVESTIGATORS TRAININGS
Adherence to ICH/GCP standards
Local regulations
Protocol specific requirements
IMPORT /EXPORT
Import of IP during study conduct
Import of IP until commercialization
Lab kits and other supplies