Implementing Risk Based Monitoring

The cost and complexity of clinical trials have grown dramatically in recent years. One third of study's cost can be attributed to the traditional on-site review of trial data. This approach, heavily reliant on exhaustive source data verification, has proven to be not only resource-intensive, but limited in its ability to identify and prevent issues. Efficient monitoring is critical to protect the well-being of trial participants and to maintain the integrity of final results, it is generally accepted that the process for clinical trial monitoring needs to change.

  • Data Integrity
  • Detection of Critical Data and Processes
  • Risk Assessment


 


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