What is SMO?
Site management organization (SMO) is an organization that provides services to the investigator at clinical site. SMOs can perform all the work involved in clinical trial at the site.
Some examples of work scope include:
- Contract and Legal Agreement
- Documentation preparation (such as informed consent form (ICF), tracking form, recruitment materials)
- Submission of clinical trial to institutional or central review board
- Subject recruitment and follow up
- Reporting of serious adverse events to sponsor, CRO, and overseeing review board
Similar to CROs, services at SMOs are done through contractual agreement. Although the services are outsourced, the investigator at site is still the responsible party and need to oversee the quality of the work done by the SMO.
Benefits and Risks in Using a SMO
Potential benefits of outsourcing to SMOs include:
- Reduction of time and resources needed to conduct a clinical trial.
- Lower initial investment and on-going costs in hiring personnel, equipment, and facilities needed.
- Expand greater access to expertise.
- Get access to standardized process of clinical trial conduct.
Potential risks of outsourcing to SMOs include:
- Reduced control in direct management of clinical trial conduct
- Potential cost overrun due to unexpected delays
- Consistency from project to project may vary depending on personnel turnover at SMOs
Growing Trend in Outsourcing Work to SMOs
Some of well-known SMOs include PharmaTrials, PMG Research, Remington-Davis Clinical Research, Syreon, Trial Management Group (in Canada), etc.
Similar to the growing trend for CROs, the industry trend is heading toward the outsourcing model. Investigators are outsourcing more and more of the work out to SMOs. Large CROs are expanding the scope of work to offer SMO services. Yet there is room to grow for smaller SMOs in different regions of the world. The trend for outsourcing of clinical trial related work remains strong for the foreseeable future.
- Clinical Trial Site
- Contract Research Organization (CRO)
- Institutional Review Board (IRB) or Ethics Review Committee (ERC)
- Regulatory Body