Clinical Trial Management

A CCSA project team is assembled to address each client's specific needs, focusing on cost-effective and timely procedures. From expert regulatory affairs professionals to experienced CRAs, a CCSA team is prepared to assist with:

Study Start-up

• Site Identification, Qualification, and Selection
• Investigator Recruitment
• Investigator Agreement/Payment
• Study Supply Management
• Central Laboratory Management

Study Documents

• Study/Regulatory Manual Preparation and Distribution
• CRF Design, Development, Printing and Shipping
• IRB/Ethics Documentation Preparation, Submission and Tracking

Study Personnel

• Investigator and Initiation Meeting Planning and Organization
• Site Training
• Investigator/Patient Retention Strategies

Site Visits

• On-site Monitoring (Pre-Study, Initiation, Routine, Close-out)
• On-site Audits
• GCP/ICH/NIH/OHRP Compliance
• Query and Discrepancy Resolution
• Site Education

Safety Surveillance

• Safety Data Management, Processing, Reporting
• DSMB Establishment and Management
• Medical Monitoring
• Regulatory Affairs