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Dr. Nuala Murphy, the Executive Vice President, Global Clinical and Data Operations for ICON Clinical Research, recently spoke with Applied Clinical Trials about ICONIK Monitoring, the first in a series of new services utilizing the company’s ICONIK technology platform.
Murphy said the ICONIK integration information platform was developed with a view to provide transparency and chain-of-custody throughout the management, reporting, and analysis of data in relation to drug development. “By combining and centralizing clinical and operational data from multiple sources, initially CTMS, laboratory, and imaging, ICONIK provides a single holistic view of study information and enables the data to be presented in an easy to understand visual way. This access to the real time data of the ICONIK platform and associated processes provides immediate access to critical trial information in a format that enables rapid and accurate decision making, thus improving data quality and subject safety while yielding significant operational efficiency gains.“
ICONIK Monitoring is one of many services that are enabled by the operational and clinical data that is contained in ICONIK. In fact, ICON announced ICONIK Patient Safety only weeks after the Monitoring service, as its next offering from the ICONIK technology platform. In this case, the service offers a systematic way to monitor safety trends in accumulating data, spot potential safety issues and take appropriate corrective and preventive action while the study is on-going.
In a similar way, ICONIK Monitoring uses event triggers, data volume triggers and risk based triggers to ensure the most effective use of monitoring resources. Says Murphy, “This early detection then allows effective monitoring strategies to be applied, thus preventing serious and progressive data integrity problems from developing. Many of the remedial actions can be discussed with sites and implemented without the need to physically visit the sites. So ICONIK Monitoring is not only a more efficient way to monitor, it can also be a much more cost-effective way of monitoring studies as well.”
According to Murphy, the ICON approach is to systematically review alternative monitoring strategies as part of any protocol or portfolio in development, and to do this as early as possible in the design phase. “What we try to do is to pilot the ICONIK monitoring model at the same time as applying a traditional monitoring model, and in doing so, we have been able to show that ICONIK has enabled us to be more proactive in identifying issues and increase quality. As a result, what we have seen is many sponsors are willing to adapt the monitoring approach during the course of the study based on a data driven approach. I think Sponsors are more and more open to looking at implementing monitoring across a range of therapeutic areas.