Depending on your study requirements, the startup process can be individualized to meet your specific needs.
Site identification/feasibility/selection
Ethics submission
Investigator contract management
Essential document distribution/collection
Study Master File management
Tracking/reporting
The Project Manager is the main point of contact for the client and is accountable for meeting the objectives of the study, regardless of size or complexity.
At CLINWest, the Project Manager will:
Lead and manage cross-functional teams
Ensure timely delivery of data
Proactively manage the study budget
Maintain close communication with clients and sites
Track key milestones and metrics
Clinical Monitoring
At CLINWest, each CRA is trained on corporate SOPs to ensure consistency and quality of services, including:
Pre-Study Site Visits
Site Initiation Visits
RoutineMonitoring and Close-Out Visits
Source data verification
Investigator site file review
Investigator product review and reconciliation
Safety reporting
Data query resolution
GCP Auditing
CLINWest provides a range of GCP Quality Assurance services, including:
Investigator site audits
Trial Master File audits
Vendor audits (e.g., CRO, IRB)
GCP training
Development/review of standard operating procedures
