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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.

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White Paper: Ensuring the Adequacy of the Informed Consent Process in GCP Regulated Environments
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White Paper: FDA Inspections of Clinical Investigators: Are You Ready?
White Paper: How to Use Risk-Based Monitoring and Clinical CAPA to Ensure Compliance
White Paper: How Quality and Compliance Can Help Reduce the Cost and Time Involved in Executing Clinical Trials
Product Data Sheet: MasterControl Clinical Quality Management System (CQMS)™
Product Data Sheet: MasterControl Risk™
Product Data Sheet: MasterControl eTMF Manager™
Demo Video: MasterControl Quality Management System (QMS) Overview

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.

Some of the benefits of the MasterControl CQMS solution include:

  • A configuration model based on the global standard DIA Reference Model, which provides a central repository for all critical TMF documents and increases efficiency
  • A variety of methods for batch importing and exporting of content to and from the system
  • TMF project management capability that allows users to plan their TMF documents and tasks with automated reminders and updates as tasks are executed and promoted through various lifecycles
  • The ability to link, search, and report on each clinical site’s information and documents (i.e., facilities, equipment, past trial participation, audit history, site-specific documents, study-specific documents, etc.)
  • The capability to execute and close out quality tasks efficiently through the use of integrated processes, audits, and site information, all of which dramatically improves compliance
  • Customizable training according to user roles and methods used (i.e., virtual class, ad hoc, etc.)
  • Training that utilizes proficiency tools such as questionnaires, tests, and quizzes
  • Training tasks that can be set for automatic scheduling and audited

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

For More Information about Clinical Risk Management

For additional details about the clinical risk management system available from MasterControl, please MasterControl representative or by calling 800-942-4000.