Icon, the global provider of outsourced development services based in Ireland, has launched a real-time safety monitoring service for clinical trials as the latest iteration of its Iconik technology platform.
By identifying potentially significant clinical issues in real-time, Iconik Patient Safety offers a systematic approach to monitoring safety trends in accumulating study data and taking “appropriate corrective and preventative action while the study is ongoing”, the company explained.
In August Icon launched Iconik Monitoring, a service designed to facilitate more effective use of monitoring resources in clinical trials by tracking real-time study data. This was in line with guidance on risk-based monitoring issued by the US Food and Drug Administration and European Medicines Agency.
With Iconik Patient Safety, clinical-trial data can be queried dynamically at any level of detail (single-patient, single-site, across an entire study/compound), helping sponsors to make “informed, data-driven decisions” on patient treatment and safety, study direction and regulatory reporting, Icon noted.
In doing so, the service eliminates the need for lengthy, manual reviews of individual patient files, so that aggregated safety events may be examined more swiftly and easily across study populations, the company added.
By using Iconik Patient Safety, study teams can “maintain a view of a drug’s evolving safety profile by accumulating safety data in real-time and allowing for quick identification of emerging safety issues, affording greater protection of patients’ well-being”, commented Dr Peter Schueler, senior vice president, medical & safety services for Icon Clinical Research.
Before Iconik Patient Safety, “this level of dynamic analysis and management of patient safety was simply not possible,” Schueler said.