While the CTC can provide complete study coordination to an investigator, they can also provide any one of a range of services including, but not limited to:
- Site selection and feasibility assessment
- Budget development and negotiation, facilitate contract negotiations and execution, financial billing compliance approval , financial tracking and management
- Logistical considerations and planning, study start up and staff training
- IRB Preparation and submission, IRB amendments, adverse events, annual reviews
- Regulatory document compilation and maintenance (FDA approval of INDs and IDEs, Medicare billing approval)
- Design of Source documents and Case report forms
- Patient Recruitment, Screening, Consenting and Follow Up
- Drug administration, dispensing and accountability
- Phlebotomy and specimen processing and storage
- Data management services (data collection, data entry, internal QA/QI audit program)
- Study close out and archive