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 subjects’ rights, well-being, integrity and safety and the assurance of quality of data and the trial credibility



RISK ASSESSMENT

Configurable risk assessment and data identification processes, risk assignment, risk evaluation, risk detection, risk control, risk communication, risk review, risk reporting.

INTEGRATED

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.

FLEXIBLE

Built on configurable cloud platform accommodates vast and varying needs of clinical trials with flexible point-and-click configuration and customizations to fit each study needs.

COLLABORATION

Supports cross-functional study team collaboration to review critical risks centrally, Manage all cross-functional risk management activities through seamless end-to-end workflows.

SCALABLE

Built on leading Salesforce.com cloud platform, Cloudbyz RBM solution is scalable, extensible, and with the ability to process large amounts of data to provide real-time visibility.

REPORTING

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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