- Complete Study Management
Management of your entire clinical trial, from beginning to end.
- Study Start-up
Includes all start-up activities, such as budget preparation and negotiation, IRB and contract support, logistics, and other approvals as needed. The approved study is transferred to the department at the site initiation visit.
- Clinical Trial Consultation
A no-cost, preliminary discussion to determine the scope and needs of a specific project.
- Clinical Research Coordinators (CRCs)
The CRC Pool provides trained and credentialed CRCs for short-term projects. Services include data management, query resolution, assistance with regulatory paperwork, study start-up and close-out, and patient enrollment.
- IRB Preparation and Review
Preparation or review of IRB applications, modification requests, or annual reports.
- FDA Application (IND/IDE)
Preparation and submission of Investigational New Drug/Device application, amendments, exemptions, annual and safety reports. Maintenance of communication with FDA.
- Monitoring and Quality Assurance
Assistance with monitoring and quality assurance of investigator-initiated and industry-initiated trials. We help to ensure compliance with FDA, GCP, and IRB regulations, as well as with UC Davis Health System SOPs and P&Ps regarding clinical research. We aim to provide proactive and educational (rather than “for cause”) regulatory and data quality assessment.
- Coverage Analysis
Development of billing grids for protocols, consultation on EMR research functionality, and assistance with research billing questions. In-service training options include: developing coverage analysis; explanation of routine costs and services not billable in a trial; use of tools available on the CTSC website for developing billing grids; and guidance on the existing policies and procedures related to clinical trials billing.