Site management organization
Encyclopedia
A Site Management Organization (SMO) is an organization that provides clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...

 related services to a contract research organization
Contract research organization
A contract research organization, also called a clinical research organization, is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services...

 (CRO), a pharmaceutical company, a biotechnology
Biotechnology
Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...

 company, a medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...

 company or a clinical site
Clinical site
A clinical site is a medical facility staffed with a clinical investigator and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to...

. The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol
Clinical trial protocol
A clinical trial protocol is a document that describes the objective, design, methodology, statistical considerations, and organization of a clinical trial...

. The scope of an SMO's responsibility is limited to the 'site' and hence the eponymous title. Some (but not all) of the responsibilities include:
  • Contract
  • Submission for Institutional Review Board
    Institutional review board
    An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...

     or Independent Ethics Committee (IRB/IEC) approval. In Europe, subsission to Ethics Committee is often done by sponsor or by CRO, i.e. not by SMO
  • Patient Counseling
  • Patient Recruitment
  • Patient Follow-up
  • Informed consent
    Informed consent
    Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...

     form (ICF) translation into vernacular languages . In Europe, this is often done by the Sponsor or CRO
  • Site initiation and trial close-out operations
  • Trial-related documents archival and maintenance
  • Reporting serious adverse event
    Serious adverse event
    A serious adverse event in human drug trials are defined as any untowardmedical occurrence that at any dose#results in death,#is life-threatening#requires inpatient hospitalization or prolongation of existing hospitalization...

    s to the Sponsor or CRO and the IRB/IEC
  • Ensuring protocol compliance
  • Advising & alerting investigators of potential protocol violations
  • Advising & alerting investigators of potential ICH-GCP
    ICH-GCP
    International Conference on Harmonisation - Good Clinical Practice ICH-GCPClinical studies should be carried out according to International Conference on Harmonisation / WHO Good Clinical Practice standards...

     violations

Origin

SMOs are relatively new entrants into the field of clinical research
Clinical research
Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use...

 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
Market research
Market research is any organized effort to gather information about markets or customers. It is a very important component of business strategy...

firm.
The source of this article is wikipedia, the free encyclopedia.  The text of this article is licensed under the GFDL.
 
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