clinical operations


The integrated network of the Galenus offices allows us to successfully conduct multinational studies within tight timelines, according to ICH/GCP standards and local requirements. Our experienced staff ensure the success of your trial - from site selection, to initiation, high quality patient enrolment and site closure activities.

We provide the following clinical development services for our clients::

Study set-up

  • study feasibility
  • protocol development
  • case report form (CRF): design and printing
  • site qualification and selection
  • collected regulatory documention
  • investigator contracting
  • IRB/IEC submission
  • submission to competent authorities and national regulatory bodies
  • study team training
  • investigator meeting
Study monitoring
  • site identification, evaluation and selection
  • site visits (initiation, interim monitoring and close-up)
  • site clinical team training
  • high level source data verification
  • data query management
  • conducting of drug accountability
  • protocol and ICH/GCP compliance
Study management
  • project planning, tracking and progress reporting
  • timelines and budget management
  • project team - formation and management
  • project team - meetings and communication plan
  • integrated process across functions



 

copyright © 2014 Galenus G&H AG