Services currently offered by CCCG include but are not limited to the following:

 

Project Management

• Cross-functional management and oversight from study start-up to close-out in the areas of:
  • Scope Management
  • Budget Management
  • Timeline Management
  • Vendor Management
  • Risk Management and Issue Resolution
• Organizational Change Management
• Project Management Methods and Strategy Implementation
• Resource Management
• Portfolio and Program Management
• Ongoing Study Maintenance
  • Management and Delivery of Key Milestones and Deliverables
• Study Closeout Activities
• Training Services
  • Leadership
  • Project Management Fundamentals
  • Project Risk Management
  • CAPA/Risk Mitigation
  • Effective Communication and Team Collaboration Techniques

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Clinical Operations Management

• Investigator/Site Management
• Clinical Monitoring
• Clinical Development Services
• Clinical Data Management

 

Data Management

• Database Planning and Design
• Database Builds
• Data Entry
• Database Software Management
• Clinical Project Data Management

 

Quality Assurance

• Clinical Operations Quality Oversight
• Inspection Readiness and Audit Preparedness
• Corrective and Preventive Action Responses/Management

 

Trial Master File Management

• TMF Project Management from study start-up to close-out
• TMF Audit/Inspection Readiness
• Document Filing and Management

 

Site Networks and Study Start-up

• Fast startup sites
• Site Contact details
• Site selection and validation
• Patient recruitment and retention