Site Management Organization Clinical Research

clinical research courses

What is site management organization (SMO)?

An organization that provides clinical trial-based services to a clinical research organization, a biotechnology company, a pharmaceutical company, or even a clinical site is known as a site management organization. The site is generally a hospital or a healthcare institution having adequate staff and infrastructure to meet the requirements of the clinical protocols. The site management organization (SMO) is responsible for contracts, submission of relevant documents to the ethics committees and review boards, patient counseling, patient recruitment, site initiation and close-out operations, informed consent forms, patient follow-ups, making sure of protocol compliance, advising and alerting on various matters, archival of trial-related documents and their maintenance, regarding and taking suitable actions on multiple violations with respect to protocols, etc.


How SMOs work?

An SMO receives its income from a clinical trial fee related to the completion of a specific patient visit. Thus, the balance between income and costs can be very delicate with fewer studies or less patient recruitment. The whole success of an SMO is solely based on the first-hand knowledge of the patient population and well-defined relationships with investigator networks, enabling them to deliver and add value to the organization. More importantly, for a sponsor, this value is added to another line of the cash flow to that of a clinical research organization.

An SMO works with the same line or network of investigators, clear benefits in terms of quality of data and consistency can be achieved. SMO have their independent standards of working along with independent work protocols and procedures, which put their investigators through common or generic clinical research training accompanied by some of the best clinical research courses. It can be seen that the SMO provides a common umbrella over its entire network of investigators reducing management or administrative support that a sponsor would need to provide to each site.


Conclusion

Contract research organizations struggle to ensure the quality and accuracy of protocol feasibility. They infrequently work with their investigator sites and have less knowledge with respect to the logistical arrangements. As SMOs have a good and strong relationship with these authorities, they easily overcome these difficulties making it a very lucrative business opportunity in today's world.

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