Risk Based Monitoring (RBM) is the adequate mix of strategies including centralized and on-site monitoring practices with the goal of human subject protection and trial integrity. RBM is an important part of a pro-active clinical trial management monitoring approach, which aims to identify, assess, control, communicate and review the risks associated with the clinical trial during its life cycle in order to protect trial subject's rights, well-being, integrity and safety and the assurance of quality of data and the trial credibility.
Configurable risk assessment and data identification processes, risk assignment, risk evaluation, risk detection, risk control, risk communication, risk review, risk reporting.
Integrated with CTMS, EDC, eCRF, IVRS/IRT to provide real-time visibility on clinical trial data and performance metrics across sites. Seamless data flow across trial process.
Built on a configurable cloud platform, it accommodates vast and varying needs of clinical trials with flexible point-and-click configuration and customizations to fit each study need.
Supports cross-functional study team collaboration to review critical risks centrally, manage all cross-functional risk management activities through seamless end-to-end workflows.
Built on the leading Salesforce.com cloud platform, the Cloudbyz RBM solution is scalable, extensible and has the ability to process large amounts of data to provide real-time visibility.
Provides targeted, actionable, sustained, meaningful reporting that enables trial teams to take action on the issues detected with configurable and point-and-click reports and dashboards.
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