Site management organization

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Please improve this article if you can. (November 2007)

Site management organization (SMO) could refer to an individual, a network of individuals or an organization that sub-contracts clinical trial-related responsibilities from a contract research organization (CRO). Some, but not all responsibilities could include:

  • Contract negotiations with the trial institution
  • Institutional review board (IRB) approval
  • Patient recruitment
  • Patient follow-up
  • Informed consent form (ICF) translation into vernacular languages
  • Site initiaton and trial close-out operations
  • Trial-related documents archival and maintenance
  • Reporting serious adverse events to the CRO and the IRB/IEC

[edit] Origin

SMOs are relatively new entrants into the field of clinical research and have since grown at an explosive rate in the U.S. and other countries like India, China and Brazil where clinical trial outsourcing has been at its peak. The fledgling SMO industry is currently valued at about $3 billion and is expected to grow further according to recent estimates from R&D Directions - a market research firm.

[edit] List of SMOs

Some of the leading SMOs are:

  • SMO-India Clinical Research (I) Pvt.Ltd.(SMO-India)
  • Radiant Research
  • Protocare
  • ICSL
  • nTouch Research
  • GCT (Global Clinical Trials) in South Africa (www.gctrials.co.za)

[edit] Resources

  • www.centerwatch.com/bookstore/samples/smorpt01.pdf