Medidata said Thursday that it has launched Strategic Monitoring solution to help sponsors and contract research organizations (CROs) facing increased costs and regulations in the area of monitoring.
Initially introduced at the NEXT Global event on Nov. 8, the Strategic Monitoring is a solution that defines and executes a holistic, workflow-driven monitoring approach, enabling sponsors and CROs to identify risks and document actions in real-time.
The solution also complies with the new International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 Guidelines required for global clinical trials. Such compliance will help sponsors and CROs conduct clinical trials more efficiently according to global regulations, including domestic rules.
The company expects that the solution, when combined with the existing Medidata cloud, will provide a more effective clinical trial timelines and ultimately improve the efficiency of clinical research.
"We created Medidata Strategic Monitoring after carefully reviewing the regulatory position papers, ICH Guidelines and TransCelerate RBM technology requirements," said Kyle Given, managing director of Strategic Monitoring solution. "This system was designed to create a unified analytics platform for centralized monitoring, enabling Sponsors and CROs to identify patient, site and study level risks, and implement a set of traceable corrective actions that helps sites comply with protocol requirements -- ensuring patient safety."
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