Our Regulatory Affairs group supports PIs and their study teams in all aspects of clinical research.
Our Project Management sub-division is responsible for the planning, management, and oversight of multi-site, investigator-initiated clinical trials that support the university's overall mission.
Our data management sub-division assists with the design, collection, and management of study data for a clinical research study.
Our site management group oversees the conduct of a clinical trial at the investigative site and ensures that it is conducted, recorded, and reported in adherence to the protocol, SOPs, ICH-GCP, federal regulations, guidance documents, and state and local laws and applicable policies.
The clinical trial Disclosure sub-division within CRMSO assists with the development, oversight, monitoring, and facilitation of support systems for Clinical Trial Disclosure at the University of Miami.
