Clinical Risk

Clinical Risk Management

In clinical environments, risk is defined as the combination of the probability of the occurrence of harm and the severity of that harm. To improve operational decision making and to meet compliance requirements, many companies engaged in clinical trials employ the use of clinical risk management applications.

The clinical quality management system (CQMS) available from MasterControl is a complete clinical risk management solution designed to enhance transparency and manage risk throughout the life of a clinical. Improving clinical risk management accelerates task execution increases the likelihood of compliance throughout the entire clinical trial process. The MasterControl CQMS solution streamlines clinical tasks and promotes reuse of information between internal and external contributors.

MasterControl Clinical Quality Management System (CQMS)™

Comprehensive and Effective Clinical Risk Management with MasterControl

MasterControl provides a single platform for all clinical risk management documentation, tasks, and activities for compliance purposes. It can serve as the centerpiece of an organization’s risk management efforts and will bring all stakeholders together for a holistic approach to compliance. It offers robust risk assessment application tools such as risk matrix, which can measure acceptable and unacceptable risks. MasterControl CQMS also offers robust analytics and reporting tools to help you evaluate risks and address them promptly.

Benefits of the MasterControl CQMS Solution


Efficient Configuration Model


TMF Project Management


Clinical Site Monitoring


Quality Management


Training Tools

Clinical Risk Management Components of MasterControl CQMS

  • Project Risk

    Study Timeline, Tasks Overdue, Completion Percentage

  • Clinical Procedure

    GCP Documentation, Patient Enrollment, Safety, Data Integrity, Product

  • Accountability / Storage, CAPA/ Deviations

    Volume, Frequency, Trends

  • Vendors/Partners

    Risk-based Vendor Qualification/Selection

  • Sites

    Risk-based Study Site Qualification / Selection

  • Audit

    CRO and Site Audits: Violation, Finding, Deviations, Follow-up / Corrective Action

  • Training

    Completed, Outstanding, Overdue

Free Resources

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