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Clinical Monitoring PDF Print E-mail

MedHimalayas provide clinical monitoring services by trial specific Clinical Research Associates . The monitors are ICH-GCP trained and  work closely with the investigation sites to achieve quality results.

  • Site identification
  • Feasibility assessment and selection
  • Investigator team training
  • Site initiation and review of regulatory documents
  • Safety and quality monitoring including source and regulatory documents review, data retrieval, SAE reporting, assessment of protocol adherence and Investigational Product accountability.
  • Query  management  and database lock
  • Study close out and data archiving
 
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