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           Protocol Development
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Clinical Monitoring

Clinesian’s team of clinical research associates (CRAs) is experienced in several therapeutic areas and will expertly monitor your clinical trial.  Our team of CRAs have a minimum of 5 years of clinical trial monitoring experience. We ensure that our CRAs have been extensively trained in GCP/ICH guidelines and FDA regulations.   Our CRAs are also based regionally to provide cost savings for the Sponsor.   Clinesian’s project manager assigned to your project will oversee the regional CRAs to ensure that the clinical data collected are of the highest quality.  Our CRAs  also work closely with the other functional groups (e.g. data management) to ensure rapid and smooth study execution.  Clinesian also offers offshore monitoring if Electronic Data Capture (EDC) is utilized.  This model allows offshore monitors to review data remotely thereby reducing the number of traditional monitoring visits from regional monitors.  This model provides added cost savings to the Sponsor yet does not compromise on the quality of the data.

Our clinical monitoring services include the following:

  • Site identification
  • Site qualification and initiation
  • Regulatory document collection
  • Informed consent review
  • Investigator meeting planning and presentation
  • Site personnel training
  • Interim site monitoring
  • Site termination
  • Data query resolution
  • Study documentation and correspondence
  • Drug accountability







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