SUPPORTING CLINICAL TRIALS IN PATIENTS WITH AN INTEGRATED SITE
MANAGEMENT ORGANIZATION
Introduction
The first question that comes to mind in discussing a Site Management Organization
(SMO) SMO is ‘why is it necessary’? In an attempt to shorten drug development time
and lower the resulting cost, patients are being included more and more in early phase
(phase I and II) clinical trials, often in combined healthy volunteer/patient studies. The
addition of patients to these early phase protocols requires the CRO to develop a
network of sites and investigators who are able to successfully enroll the right patient
population in order to conduct these trials. Therefore, one needs to enroll in clinical
research courses to equip themselves to understand the working of clinical trials.
For potential investigator sites that have the necessary patient pool, but lack the
required staff, clinical research experience, or time, the SMO can provide a
multidisciplinary team for on-site support. The additional benefit to the sponsor is the
assurance that the study managed by the SMO team at the different sites is
conducted with the same high quality SGS standards as can be expected. It is useful
to keep in mind that not just early phase trials benefit from the SMO organization, but
also late phase clinical trials. In the following examples of clinical trials performed by
SGS we demonstrate how the SMO can accommodate several types of on-site
support requests.
The aim of SGS’s SMO department is to facilitate patient recruitment for early phase
clinical trials through external sites and, if needed, to support the external site in
managing and executing the clinical trial. In the following case studies including
phase I/IIa schizophrenia, dialysis and Influenza vaccination studies, we will see how
an SMO can support efficiently the success of patient clinical trials.
Site Management Organization (SMO)
A person, company, or other organization that contractually provides clinical trial
related services to a study sponsor, contract research organization (CRO), or clinical
investigator. Site management organizations (SMOs) differ from CROs in several
ways, including that they:

Are not explicitly regulated or defined by the Food and Drug
Administration (FDA).

Generally provide services specific to the clinical study sites.