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Value of Risk Based Monitoring

A big leap in the evolution of data management was accomplished by switching from paper to electronic systems. Although this transition is still occurring, new systems are proving to benefit pharmaceutical companies in all stages of data analysis and risk monitoring. To carry out successful clinical trials in an industry with growing costs, we must look to incorporate new ways of thinking into advanced monitoring processes. Risk based monitoring involves a systematic process that takes time to put in to action. However, it is important to remember that shifts are happening and staying up to date with these changes is a necessity.

Risk Based Monitoring is key to ensuring the quality of clinical trials and enables us to eliminate risk that could compromise the results. RBM strategy can only work well if the risks applicable to the study are well defined and the appropriate risk management strategy is implemented at the onset of the trial – assuring this is completed accurately, the quality of the trial should not be compromised.

This method of monitoring has various valuable credentials that it can offer; this including centralized monitoring which allows for much of the study oversight and review to be done remotely. A risk dashboard in a separate location is designed to provide you with obvious visual cues to determine the high risk trail sites. The industry will save funds across on-site monitoring as this will only be accessed when high risk trials flag as a concern.

Other values of Risk Based Monitoring include:

  • Fewer errors
  • Better analysis
  • Cross-site comparison
  • More timely results

Countdown to Clinical Data Integration & Management




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