INDIAN INSTITUTE OF CLINICAL
RESEARCH & MANAGEMENT
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INDIAN INSTITUTE OF CLINICAL 
RESEARCH & MANAGEMENT INDIAN INSTITUTE OF CLINICAL 
RESEARCH & MANAGEMENT INDIAN INSTITUTE OF CLINICAL 
RESEARCH & MANAGEMENT
 
 
 
PLAYERS IN CLINICAL RESEARCH
 
Major Players in Clinical Research are
 
  • Sponsor
  • Principal Investigator(PI)
  • Independent Ethics Committee(IEC) or Institutional Review Board(IRB)
  • or Ethics Committee(EC)
  • Contact Research Organisation (CRO)
  • Monitor/ Clinical Research Associate(CRA)
  • Site Management Organisation (SMO)
  • Clinical Research Co-ordinator (CRC)
 
Sponsor :
 
In the regulations a sponsor is defined as “a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or a pharmaceutical company…”
Sponsors are responsible for:
  • Selecting qualified investigators
  • Providing the investigators with the information they need to conduct an investigation properly
  • Ensuring proper monitoring of the investigation
  • Maintaining an effective IND with respect to the investigations.
  • Ensuring that the investigation is conducted in accordance with the general investigational plan and protocols contained in the IND
  • Ensuring that the FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug
 
Principal Investigator (PI) :
 
The PI is the individual who conducts, supervises and is responsible for all aspects of a clinical trial.
 
Independent Ethics Committee (IEC) or Institutional Review Board (IRB) or Ethics Committee (EC)
 
An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects. It is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans.
 
Contact Research Organisation (CRO)
 
CRO is a company or organization contracted by a pharmaceutical, medical device, or biotechnology company (called a clinical trial sponsor) to assume various aspects of the clinical research process (i.e., to conduct clinical research trials on behalf of the sponsor)
 
Clinical Research Associate (CRA)
 
The monitor/CRA is the principal communication link between the sponsor and the investigator and is appointed by the sponsor
 
Site Management Organization (SMO)
 
A Site Management Organization (SMO) is an organization that provides clinical trial related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company or a clinical site.
 
Clinical Research Co-ordinator (CRC)
 
Responsible for coordinating all aspects of the clinical trial and day to day operations of the research program.
 
 
 
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NEWS & EVENTS
Admissions open for M.Sc., in Clinical Research, and PG Diploma in Clinical Research & Clinical Data Management, With 100% Placement Assurance*.
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