Resources

Support Service

Regulations

Study Creation

Resources

• Investigators
• Clinical Trial Sites
• Service Providers
• Epidemiology Data

Support Service

• Study Design Support
• Feasibility Service
• Disease Registries

Regulations

• Protocol Development
• Pre-Study Visit
  • Site Selection
  • Contract Finalization & Prerequisites
  • IRB/EC Approval

Study Start-up

Resources

• Investigators
• Clinical Trial Sites
• Service Providers

Support Service

• CTMS
• EDC / eCRF System

Regulations

• Study Start-up
• Site Activation
  • IP/Supplies On-site Arrival
  • Essential Document Readiness
  • System Utilization (e-CRF, IWRS, etc)
  • Site Initiation Visit

Conducting Study

Resources

• Investigators
• Clinical Trial Sites
• Service Providers

Support Service

• CTMS
• EDC / eCRF System

Regulations

• Conducting Study
• Interim Safety Analysis
• Monitoring
• Audit
• Subject In & Out

Study Completion & Close-out

Resources

• Investigators
• Clinical Trial Sites
• Service Providers

Support Service

• CTMS
• EDC / eCRF System

Regulations

• Study Completion
• Study Close-out
  • Compile All Clinical Documentation
  • Data Query Cleaning
  • Reconciliation Data
  • Data Review

Data Analysis, etc
& Regulatory Submission

Resources

• Investigators
• Clinical Trial Sites
• Service Providers

Support Service

• CTMS
• EDC / eCRF System

Regulations

• etc
  • Statistical Data Analysis
  • Clinical Study Report
  • Regulatory Dossier Compile
  • Reconcile Documents
  • Reconcile Supplies
  • Archiving Study Documents