What is an SMO? - All You Need to Know About Site Management Organizations

A site management organization, or SMO, is an organization providing services related to clinical trial site management for pharmaceutical companies, drug developers, clinical sites, or even contract research organizations (CROs) running clinical trials. Their specific responsibilities revolve around managing the site – the physical location – where a clinical trial is being conducted.

What Does SMO Mean?

SMO stands for site management organization, which is an entity that provides clinical trial services to a sponsor conducting a clinical trial. They typically have a network of sites which are ready to participate in a trial. SMOs offer to manage the operations at these sites. The SMO is typically made responsible for:

Verifying compliance with regulatory requirements
Facilitating administrative processes
Overseeing activities conducted on-site, including providing documentation services
Managing site staff
Managing recruitment of patients
Monitoring study sites and participants
Assisting with the trial start-up and close-out

Some SMOs may also provide input on study design, manage data collection, conduct quality assurance reviews of data collected by the site leads, and oversee the overall progress of the study.

The SMO may be an independent company or it may be part of a larger organization that offers other clinical research services. Some SMOs own a network of sites which can be mobilized for clinical trials, already counting on their own organizational structure and staff members to make everything run as smoothly as possible.

The SMO usually consists of:

A project manager, who oversees the entire study
A site lead for each location where participants are recruited or data is collected
Other team members, like coordinators or nurses

The SMO works with the sponsor—the company funding the trial—to ensure that all regulatory requirements are met and that the study is carried out in accordance with ethical standards.

Benefits of SMOs

It's no secret that clinical trials are complicated, time-consuming, and expensive. But there are ways to make them less so; site management organizations specialize in streamlining the process and reducing the costs of trials.

The benefits of using a SMO include:

Cost savings. Contracting an SMO often means that the sponsor doesn't have to hire staff or rent study sites meaning that the sponsor won't have any additional costs associated with managing trial site(s) or their management team(s).
Faster recruitment. Recruiting is often one of the most time-consuming parts of running a clinical trial. An SMO will often know how to find patients in their own network and can often do it faster than a sponsor would be able to on its own, amidst all of the other responsibilities sponsors typically face during a clinical trial.
More reliable results. SMOs have access to many resources and a wide network of contacts. They often have a large pool of patients to draw from, and have lots of experience working in clinical trials in general. They have access to clinical trial sites and have built up relationships with these sites over time, giving them greater flexibility in terms of where they can recruit patients from and inferring greater familiarity with the specifics of each site’s operational structure.
Better communication. An SMO will keep in touch with the sponsor throughout the recruitment and executions processes and provide regular updates on how things are going. In the case of any problems or setbacks, an SMO should be well-equipped to rectify the situation in a timely and appropriate fashion.
Improved data management. SMOs can help decrease delays that might occur due to data inefficiencies. They have data handling mechanisms in place to effectively manage both clinical and regulatory data. For example, SMOs can help ensure that clinical trials are conducted according to Good Clinical Practice (GCP) guidelines and other regulatory requirements. They are also proficient in documentation services, dealing with aspects such as informed consent forms (ICFs) and Institutional Review Board (IRB) submissions.

SMOs are one of the many options available to clinical trial sponsors for contracting services to experienced professionals to ensure that the trial runs smoothly, safely, in accordance with regulatory guidelines, and freeing up time for the sponsor to focus on its core activities.