An increasing trend in the life science industry is to handle operations from afar through online means, allowing executives to have more time in the office and less travel.
With less travel comes reduced costs for the manufacturing company, which is a primary reason for this popular trend. While certain activities can be easily managed remotely, the industry raises the question of applying such methods to the clinical environment, in which it is highly important to provide close and ongoing support to the study staff to ensure compliance and overall trial success.
Sponsors should understand the concept of risk-based monitoring—and as one important corner stone of this concept the “remote monitoring process”—to adjust for the future of clinical trials.
Remote monitoring allows for cost savings to the sponsor. It also lays the focus on what can already been done “off-site“ to ensure data quality and patient safety. This approach allows transition from “excessive on-site Source Data Verification” to comprehensive “risk-driven monitoring.”
You can learn more about “risk-based monitoring” at the 7th EU Device Clinical Research Conference in Dusseldorf on October 21st at 10:00. Kirsten Welz will be presenting a case study entitled Pros and Cons of Clinical Study Remote Monitoring. This talk will give clear indication what the advantages of a risk-based monitoring concept are, placing emphasis on performing remote monitoring as part of this concept. It will inform about the financial implications, the necessary prerequisites to perform successful remote monitoring and what we actually can do already now and how the future will hopefully look like.
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