Risk Based Monitoring

The Risk Based Monitoring solution by Cloudbyz is designed to enhance clinical oversight processes for sponsors. It aims to reduce time, costs, and effort while allowing real-time review of critical monitoring activities across multiple sites from a single platform. This solution is user-friendly, requiring no extensive programming or statistical expertise.

Product Features

• Risk Assessment and Mitigation: Categorize risks into high, medium, and low within the system. Prioritize these risks based on their likelihood, extent, and potential impact on trial integrity, and set up mitigation steps for each category.
• Key Risk Indicators: Identify and apply critical data and processes for each study type. Choose from existing risk indicators or create custom ones to manage key risk indicators directly within the system, enhancing data quality throughout the study.
• Reports and Dashboards: Access a variety of reports and dashboards to evaluate critical metrics. Create custom reports with point-and-click configuration and subscribe to receive important reports via email at scheduled times.
• Thresholds, Triggers, and Notifications: Establish thresholds for data collection and activities, addressing potential safety and human subject protection concerns. Receive trigger notifications with recommended mitigation actions based on the monitoring plan.
• Automations: Utilize automated reviews and analyses to minimize manual intervention and on-site monitoring. Schedule monitoring visits automatically based on system recommendations.
• Integrated: Integrate with various clinical trial management systems to control processes from one location. Extend integrations to multiple systems to maximize the automation of your monitoring plan.

Cloudbyz is committed to empowering clients by providing innovative, scalable, and intuitive cloud-based solutions that streamline operations, enhance efficiency, and drive growth. The company is ISO 9001:2015 and ISO 27001:2013 certified, ensuring high standards of quality and security.