Site Management Organization Clinical Research
Medical Research is a reputable Site Management Organization(SMO) that offers a
wide range of solutions to clinical contract organizations. We aim to facilitate each
stage of the clinical trial process and provide high-quality solutions to sponsors,
CROs, and research centers. Therefore, one needs to enroll in clinical research
courses to equip themselves to understand the working of clinical trials.
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 welldefined 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.