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Site Management Organization (SMO)
Practical Law Glossary Item w-002-1998 (Approx. 3 pages)
Glossary
Site Management Organization (SMO)
A person, company, or other organization that contractually provides clinical trial related management services to a study sponsor, pharmaceutical or medical device company, contract research organization (CRO), or clinical investigator. Site management organizations (SMOs) differ from CROs in several ways, including that they:
- Are not explicitly regulated or defined by the Food and Drug Administration (FDA).
- Provide services specific to the clinical study sites.
- Do not assume any of the sponsor's regulatory obligations listed in the FDA's investigational new drug application regulations.
- May have a network of clinical research sites which they manage.
SMO services may include:
- Identifying or managing investigators and sub-investigators.
- Hiring study staff.
- Preparing submissions to Institutional Review Boards.
- Assisting with:
- project feasibility;
- patient recruitment;
- study site initiation and close-out operations; or
- other site-specific study activities.