Clinical Trials Research Services

The division offers the following services:

Pre-study support

  • Pairing Sponsors and Contract Research Organizations with qualified clinician investigators.
  • Reviewing studies for scientific validity, institutional risk and adequate resources.
  • Coordinating safety assessment of studies involving biohazardous agents for compliance with regulations and policies.
  • Providing orientation and training for clinician investigators and site staff.
  • Assisting with site feasibility assessment for potential studies.
  • Collaborating with the Research Central Business Office for budget review of resources

Site management support

  • Hiring and managing study site staff to support studies.
  • Developing workflow processes for successful participant recruitment, and study implementation and management.
  • Assisting with sponsor communication and monitoring.
  • Conducting and coordinating study protocol assessments, specimen processing, and data collection.
  • Guiding clinician investigators and staff to ensure compliance with applicable regulations, policies, and procedures including the protection of the safety, rights, and welfare of research participants.

Regulatory support and consultation

  • Assisting with Kaiser Permanente Southern California Institutional Review Board submissions using the integrated Research Information Systems.
  • Supporting and managing expanded access (compassionate use) studies and U.S. Food and Drug Administration submissions.
  • Providing consultation on applicable federal and state regulations, and institutional policies and procedures.
  • Assisting with quality improvement initiatives through standard operating procedure review and development.
  • Reviewing for quality assurance and compliance to address and prevent noncompliance.
  • Facilitating proper retention of study records.