Facility

Site Requirements:

  • Dedicated exam rooms.
  • Dedicated office for UACR staff and study related files.
  • Locked and limited access drug and supply storage facilities.
  • Basic lab and equipment facilities for specimen and diagnostic collection. All lab and equipment facilities must be calibrated and certified as required by law.
  • Refrigeration and freezer capabilities or accessibility specific to the needs of the study drug.
  • Dedicated area for storage of study binders that has limited access and is secure.
  • Dedicated area for Sponsor monitoring visits that is well lit, comfortable and appropriate for monitoring staff.
  • Assign/ dedicated staff person trained as the Study Coordinator.
  • Assign/ dedicated technician/coordinator to conduct study related lab requirements for all assigned studies
  • Maintain a system for quickly identifying patients by diagnosis or condition (preferable a dedicated staff member who could conduct chart reviews during pre-screening/screening process for qualified patients).

Site Management:
UACR provides the following:

  • Assignment of a dedicated Clinical Research Project Manager/ Director to oversee the clinical operations.
  • Marketing and business development of UACR and its capabilities for all upcoming research trials and opportunities
  • Complete Study feasibility questionnaires
  • Budget Negotiations with Sponsor/CROs
  • Incorporating UACR specific Standard Operating Procedures (SOP’s) and/ or incorporating/ utilizing only, Sponsor’s SOPs
  • Study start-up activities to include collecting and processing regulatory documentation.
  • Subject recruitment strategies
  • CRF Completion and Query Management
  • Conducting on-site independent QA protocol audits for QA, sponsors and FDA inspection preparation and training purposes