Uploaded by Isabella Taylor

Site Management Organizations are Trending Learn How Sites Are Consolidating

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Site Management Organizations are Trending: Learn How Sites Are
Consolidating
Clinical research sites have historically been a highly fragmented industry, consisting
mostly of physician practices conducting studies on a part-time basis and small
stand-alone businesses. Now, consolidation is occurring, with sites coming together
under common ownership, or management, to operate as a single network at
an unprecedented rate. Learn more about the Clinical Research Courses
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.
The value proposition of a single network includes:

Geographic and therapeutic diversification through multiple locations and PIs

Economies of scale from centralizing functions such as business development,
budgeting, contracting, study start up, finance and accounting, QA and IT

Standardization of workflows and processes around best in class SOP’s

Enhanced negotiating leverage with sponsors through the ability to offer volume,
accelerated timelines, and data consistency
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