STARTUP SERVICES

Depending on your study requirements, the startup process can be individualized to meet your specific needs.

CLINWest startup services include:

• Site identification/feasibility/selection
• Ethics submission
• Investigator contract management
• Essential document distribution/collection
• Study Master File management
• Tracking/reporting

PROJECT MANAGEMENT

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