The Clinical Trials Office (CTO) currently manages more than 90 clinical trials within the Department of Medicine at the Icahn School of Medicine at Mount Sinai. The CTO office also works closely with Institutional Committees, including the Program for the Protection of Human Subjects.
We maintain compliance with all institutional, state and federal regulations throughout the course of each study. This CTO administrative infrastructure allows investigators to obtain approval for studies in a timely manner and supports institutional compliance with regulatory requirements. Principal investigators and their research teams are thereby able to focus the majority of their attentions on the scientific content and patient care of research.
Specifically, the CTO provides comprehensive services to support clinical investigators with:
- Document preparation and submission to internal Department of Medicine Protocol Review Committee.
- Determine in collaboration with Investigators protocol feasibility.
- Financial Management during the lifecycle of the study.
- Collaboration with sponsors and/or contract research organizations to prepare all pre-award documentation, including regulatory submissions.
- Centralized study processes through the 3 Core Teams: Regulatory Affairs, Financial Management, and Clinical Coordinator.
- The CTO staff serves as a clinical, regulatory, and financial resource for physicians and their staffs.