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You are here: Home / Site Management Organization (SMO)

Site Management Organization (SMO)

What is SMO?

Site management organization (SMO) is an organization that provides services to the investigator at clinical site. SMOs can perform all the work involved in clinical trial at the site.

SMO Services

Some examples of work scope include:

  • Contract and Legal Agreement
  • Documentation preparation (such as informed consent form (ICF), tracking form, recruitment materials)
  • Submission of clinical trial to institutional or central review board
  • Subject recruitment and follow up
  • Reporting of serious adverse events to sponsor, CRO, and overseeing review board

Similar to CROs, services at SMOs are done through contractual agreement. Although the services are outsourced, the investigator at site is still the responsible party and need to oversee the quality of the work done by the SMO.

Benefits and Risks in Using a SMO

Potential benefits of outsourcing to SMOs include:

  • Reduction of time and resources needed to conduct a clinical trial.
  • Lower initial investment and on-going costs in hiring personnel, equipment, and facilities needed.
  • Expand greater access to expertise.
  • Get access to standardized process of clinical trial conduct.

Potential risks of outsourcing to SMOs include:

  • Reduced control in direct management of clinical trial conduct
  • Potential cost overrun due to unexpected delays
  • Consistency from project to project may vary depending on personnel turnover at SMOs

Growing Trend in Outsourcing Work to SMOs

Some of well-known SMOs include PharmaTrials, PMG Research, Remington-Davis Clinical Research, Syreon, Trial Management Group (in Canada), etc.

Similar to the growing trend for CROs, the industry trend is heading toward the outsourcing model. Investigators are outsourcing more and more of the work out to SMOs. Large CROs are expanding the scope of work to offer SMO services. Yet there is room to grow for smaller SMOs in different regions of the world. The trend for outsourcing of clinical trial related work remains strong for the foreseeable future.

Related pages

  1. Clinical Trial Site
  2. Contract Research Organization (CRO)
  3. Institutional Review Board (IRB) or Ethics Review Committee (ERC)
  4. Regulatory Body
  5. Sponsor
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My name is Polachai Ernie Sakchalathorn and I’m the guy behind ClinicalResesarchAssociateCRA.com. I have been in clinical research since 2007. Click on my picture above to learn more about my background and experience.

Clinical Trial Basics

  • Drug Development
  • In Vitro Diagnostic Development
  • Medical Device Development
  • Search Results

Industry Players

  • Sponsor
  • Clinical Site
  • Contract Research Organization (CRO)
  • Site Management Organization (SMO)
  • Institutional Review Board (IRB) or Ethics Review Committee (ERC)
  • Regulatory Body
  • Search Results

CRA Career Path

  • What is CRA?
  • Education and Skills Needed
  • How to Get Into a CRA Role
  • Career Development
  • CRA Certification
  • Search Results

Clinical Research Regulations

  • Historical Events behind Current Regulations
  • Food and Drug Administration (FDA)
  • ICH’s GCP Guideline
  • European Medicines Agency (EMA)
  • Country Specific Regulations – Global / International Trial
  • Search Results

Resources

  • Books
  • Jobs
  • ES’ SOCRA CCRP Exam Study Guide
  • Purchasing Multiple Copies of the ES’ SOCRA CCRP Study Guide
  • Email/Download Troublesheet & FAQs for ES’ SOCRA CCRP Study Guide
  • Search Results

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