Site Management Organizations (SMO)

 Site management organization (SMO) is an entity that sub-contracts clinical trial-related responsibilities from a  CRO.  A short list of their activities include :

• Contract negotiations with the trial institution
• Institutional review board (IRB) approval
• Patient recruitment
• Informed consent form (ICF) translation into local languages
• Site initiaton and trial close-out operations
• Trial-related documents archival and maintenance
• Reporting serious adverse events to the CRO and the IRB/IEC

Broadly they are involved in activities before the trial starts and after the actual clinical trial ends. They primarily provide trial coordination, and may be involved in obtaining customs clearance for the medical product to the tested in the trial.

SMOs are service providers who are different from a CRO in two aspects : 1. They are contracted by investigators or CROs, 2. They do not inherit the regulatory obligation as a CRO would inherit from the sponsor.

The SMO industry is valued at 3 billion USD, and is easy to establish and start operations very quickly.