Study Submission

• Master file preparation
• Collection of documentation from teams
• Monitoring the process until the approval

Start-up Phase

• Organization of documents under the scope of GCP
• Network connection with other services
• CRFs review and validation
• File maintenance

Medical Visits

• Patient Monitoring
• Coordination with other services involved
• Help patients with self-completion questionnaires
• Fill CRF with clinical teams

Monitoring

• Visits preparation
• Queries resolution
• Linking with monitors

Recruitment

• Patient identification
• Collaboration in recruitment procedures

Close-out

• Expedite study closure with Promoters
• Ensuring closure of CRF
• Notifications closing

Payments

Speed circuits:

• Payments to the Teams
• Reimbursements to patients

Fundamental

• Quality system
• Standard Operation Procedures
• Harmonization of teams procedures