PROJECT MANAGEMENT

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

OUTSOURCING

Individual professionals or project teams
Short/long-term
Wide range of experiences and positions

INVESTIGATORS TRAININGS

INVESTIGATORS TRAININGS

Adherence to ICH/GCP standards
Local regulations
Protocol specific requirements

IMPORT / EXPORT

IMPORT /EXPORT

Import of IP during study conduct
Import of IP until commercialization
Lab kits and other supplies