Implementing Risk Based Monitoring


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




  • Data Integrity


  • Detection of Critical Data and Processes


  • Risk Assessment



 


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