Clinical Trial Services
Clinical Trials Division coordinates and facilitates access to promising new therapies, quality research standards, and efficiencies in the conduct of clinical trials. The division offers the following services:
- Pairing Sponsors and Contract Research Organizations (CRO) with qualified clinician investigators.
- Reviewing studies for scientific validity, institutional risk and adequate resources.
- Coordinating safety assessment of studies involving bio hazardous agents for compliance with regulations and policies.
- Providing orientation and training for clinician investigators and site staff.
- Offering site management support, including
- Assisting with site feasibility assessment for potential studies.
- Collaborating with Research Business & Contract Operations in budget review for staffing
- Recruiting and hiring study site staff to support studies.
- Developing workflow processes for successful participant recruitment, and study implementation and management.
- Assisting with Sponsor communication and monitoring.
- Guiding clinician investigator and staff to ensure compliance with applicable regulations, policies, and procedures including the protection of the safety, rights, and welfare of research participants.
- Providing regulatory support and consultations
- Assisting with Kaiser Permanente Southern California Institutional Review Board (IRB) submissions using the integrated Research Information Systems (iRIS).
- Supporting and managing expanded access (compassionate use) studies and Food & Drug Administration (FDA) submissions.
- Providing consultation on applicable federal and state regulations, and institutional policies and procedures.
- Assisting with quality improvement initiatives through standard operating procedure (SOP) review and development.
- Reviewing for quality assurance and compliance to address and prevent noncompliance.
- Facilitating proper retention of study records.