How to Start a Site Management Organization?
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 firsthand 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.