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.
How Site management organizations (SMOs) specialize in running clinical research sites. If you decide to start an SMO, you will work for medical research companies to find a suitable facility for holding clinical research trials. Your company's duties may also include recruiting patients, drawing up budgets for trials, hiring investigators to conduct the testing, preparing budgets, and drafting and submitting the clinical study. The SMO profession is a growing field that generated $3 billion in annual revenue in 2011. Therefore, one needs to enroll in clinical research courses to equip themselves to understand the working of clinical trials.
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.
Read federal guidelines for conducting clinical trials. The U.S. Food and Drug Administration has extensive regulations detailing how to conduct medical research and report the results of drug trials and other tests. Your company must know and comply with the regulations if the FDA is to approve your clients' new products or treatments.
- Contact hospitals and clinics -- most research sites are established medical facilities -- and ask about their experience in conducting clinical trials. Talk to their researchers and administrators about the sort of research the institution has participated in, what the patient population is like -- age, ethnicity, health -- and which clinical investigators work with them.
- Develop a database of different facilities that includes their specialties, patient populations and their willingness to serve as clinical sites. Medical companies may have detailed requirements -- for example, a patient population that recently suffered a flu epidemic -- so the more diverse your list of potential sites is, the better.
- Write up a presentation showing the advantages of doing business with your company. Contact biomedical firms and clinical research organizations, offer your services and make them aware of the facilities and patient populations you have to work with.
What is site management organization (SMO)?
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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