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Clinical Monitoring

Sigma-K Corporation's Clinical Research division is proud to provide services such as Phase I Project Management, QA auditing, and site clean-up for "problem" sites.

Sigma-K Corporation also provides clinical research monitoring and auditing services for Phase I, II and III protocols.  Our clinical staff have years of experience in field monitoring and auditing of adult oncology, cardiovascular, urology and dermatologic studies.  

Our monitoring services include the following:

  • assistance with study start-up
  • assistance with CRF development
  • assistance with protocol development 
  • site/investigator identification 
  • site initiations
  • routine monitoring
  • site close-out
  • query resolution
  • site "clean up"
  • regulatory review
  • drug accountability

 

We are fully compliant with FDA code, GCP and ICH guidelines and HIPAA regulations.  

Member:  Association of Clinical Research Professionals (ACRP)
                  American Society of Clinical Oncologists (ASCO)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                                                                                                                   

 

 

 

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