What is an SMO (Site Management Organization) in Clinical Trials?

what is an smo
what is an smo

It is well known that all medical treatments must pass through rigorous testing before being released to the public. This initial testing is better known as a clinical trial. Trial results can be the make-or-break difference between a new therapy passing regulatory approval and hitting the market or not.

There are many complexities involved in running and managing a clinical trial, including patient recruitment, monitoring activities and budgets, collecting data, etc. It’s crucial for clinical trials to run efficiently and effectively to produce accurate and timely data, which is where a site management organization (SMO) comes into play.

What is a Site Management Organization (SMO)?

An SMO is a company that provides clinical trial management services to pharmaceutical, biotech, or medical companies. SMOs help sponsors streamline their administrative processes while ensuring that all regulatory requirements are met. They also support CROs and clinical investigators at the site with startup, monitoring, and closeout responsibilities.

What are the benefits of working with a site management organization?

SMOs can reduce trial timelines and costs and lead to more efficient and accurate trial results through a full range of services, including:

  • Documentation preparation (informed consent forms (ICF), recruitment materials, contracts, legal agreements, etc.)
  • Managing patient recruitment
  • Monitoring
  • Identifying and/or managing investigators and sub-investigators.
  • Managing and fulfilling staff requirements and recruitment.
  • Preparing Institutional Review Boards (IRB) submissions.
  • Assisting with trial startup, site initiation, and closeout operations

Site management organizations are an integral part of clinical trials.

Clinical trials are the pathway to new advancements in medicine reaching patients. The goal of bringing new treatments to market is to provide those suffering from medical ailments and diseases the opportunity to live happy, healthier lives.

There are many people involved in clinical trials, all of which play an essential role in the trial’s overall success. One of these key players is the site management organization. They are the bridge between the sponsor and the sites that are conducting research. The SMO oversees every aspect of running the trial at all site locations. They have a hand in everything from recruiting participants and supervising staff to managing the physical space where the study takes place — whether it’s a lab, an office building, or some other location.

Like CROs, SMOs alleviate some of the headaches of running a clinical trial of any scale (small or large). SMOs are integral for a trial to achieve accelerated timelines, streamlined processes, improved data management, and more accurate results.


Clinical trials are no easy feat and are full of complex challenges, but SMOs offer specialized outsourced services that help alleviate any pain points. SMO’s expertise in managing clinical trials typically guarantees that all aspects of the study run smoothly, from regulatory compliance to data collection and analysis.

As with any industry, there is room for improvement regarding collaboration between sites and sponsors — but SMOs have proven time and again to be valuable partners who can smoothly deliver superior trials by providing support at every stage of development.

To learn more about the Vial site network, visit our sites page for our dermatology SMO, ophthalmology SMO, gastroenterology SMO, neurology SMO, women’s health SMO, or our rheumatology SMO.

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