ABSTRACT
Site Management Organizations (SMOs) aim to enhance the quality of the patient/ investigator interface to improve the clinical trial process efficiency at the investigational site level. An SMO is characterized by the following attributes:
• Owns, leases, or has an ongoing contractual relationship with investigational sites;
• Investigational sites participate in clinical trials with potential therapeutic benefit; • Manages and assumes responsibility for undertaking clinical research on a
commercial basis; and • Customers are primarily pharmaceutical companies, biotechnology companies,
medical device companies, and CROs.
