Site Identification
Site assessment and start up Site Selection Site Feasibility Investigator and Hospital Contracts and Negotiations Amendment agreements Management of study payments
Monitoring Visits
Site Initiation Visits Routine Monitoring Visits Routine Quality Monitoring Visits Remote Monitoring Visits Close-out Visits
Project Management
Training of site staff and study team
Preparation of Documents and Study Submission
Managing regulatory authority applications and approvals Preparation and submission of Study Documents Preparation and Maintaining of Study Documents
Oversight monitoring / Co-monitoring visits
Quality and Pre-audit visits, Audit preparation, participation and follow-up
Organising payments and project budgeting
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