Clinical Investigations Support Office (CISO)

We offer comprehensive support throughout the entire lifecycle of a clinical trial, including:

• • Trial Development for Investigator-Initiated Trials – Assisting investigators in designing and developing their own clinical trials, including biostatistics support, Investigational New Drug (IND) application submission, and multisite coordination. The first step for Investigator-Initiated Trials development is the Design and Feasibility Meeting.   An overview of the steps involved in developing and conducting investigator-initiated clinical trials can be found in the USC Norris IITs: A Guidance for Investigators.
  • Trial Implementation – Overseeing the activation and execution of clinical trials, provision of research staff, coordinating interactions with sponsors, and specimen processing including for interventional and non-interventional studies.
  • Regulatory Support – Supporting investigators through the entire activation process, ensuring compliance with FDA regulations, Good Clinical Practice (GCP) guidelines, Institutional Review Board (IRB) requirements, and other applicable standards.
  • Quality Assurance – Maintaining high standards for data integrity and patient safety through monitoring of investigator-initiated and federally-funded clinical trials.
  • Staff Training & Compliance – Providing comprehensive and standardized training and oversight to all research staff.