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New Technology + Old Processes =  Very Expensive Old Processes

Today, many Clinical Trials are using electronic data capture rather than paper based CRFs. However, not all of the processes have yet been adapted to the potential of the new technology. Data is collected globally with Web based systems, transported at the speed of light to a central database, just to sit there for days and weeks because some legacy SOPs prevent the switch from the traditional batch oriented paper workflow towards the more continuous flow required to gain the full benefit of electronic data collection.

There is currently a new wave of discussions around this topic, mostly triggered by the FDA Guideline about Risk based Monitoring. The FDA is exactly suggesting what many of us have been requesting for more than a decade: Walk away from a static 6 weeks on-site monitoring and 100% Source Data Verification towards smart and dynamic monitoring, using the information you have in your central database to focus on helping the sites that need help and reduce the burden on sites performing well. 

If you are considering Risk based Monitoring, we can help you to

  • optimize your CRF design to improve data quality upon entry (it is much more effective to avoid errors than finding and fixing them downstream)
  • adjust your SOPs to implement a workflow of continuous quality control and adjustment
  • create Data Management and Monitoring plans making best use of your current technology for centralized monitoring including a detailed Risk Assessment
  • define and implement data reporting and analysis tools to identify problematic cases requiring your attention