Package Plans

  • 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.

Individual Services

  • 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.