Clinical Quality Management Software Systems (CQMS)


Combining CTMS and QMS to provide a complete CQMS

Clinical study management encompasses all activities of a clinical study, and the ability to quickly and efficiently assess a study's development and progress at any given moment. Clinical studies entail an ever changing and growing collection of data, activities and relationships that change from day to day, and visibility into critical events is essential to the success of a clinical trial. Complete clinical management combines the activities traditionally managed by clinical operations and those of clinical quality for a holistic approach to embedding quality into day-to-day clinical operations.

Successfully managing the quality of clinical studies, regardless of size, requires more than just a centralized place to house electronic trial master file (eTMF) documents. Clinical quality management must include the ability to assess the criticality and impact that the information has on the various aspects of a clinical trial. Understanding how information relates to the overall success and risk of a clinical trial becomes the true value of a clinical quality management system.

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White Paper: How Quality and Compliance Can Help Reduce the Cost and Time Involved in Executing Clinical Trials



The MasterControl CQMS (Clinical Quality Management System) solution is designed to manage all of the documents, activities, project tasks, processes, quality events, relationships, audits and training that must be administered and controlled throughout the life of a clinical trial. The MasterControl CQMS is a complete solution designed to increase efficiency and reuse of information while streamlining the processes and tasks that must be executed during the length of a clinical trial. Unlike traditional Clinical Trial Management Systems (CTMS) that focus exclusively on data collection and documentation, the MasterControl CQMS goes beyond these areas and includes a holistic approach to managing quality and risk throughout the clinical trial.

MasterControl CQMS provides an integrated approach to managing clinical information derived from various areas such as:

  • Study management
  • Site management (site qualification, site documents, IRBs, history, etc.)
  • Project management (milestones, visits, status, etc.)
  • Vendor management (CROs, IP distributors, etc.)
  • Document management
    • Electronic trial master file (eTMF) document management
    • Document exchange (partners: CROs, sponsors, sites)
    • 3rd party collaboration
  • Document control
    • Good clinical practice (GCP) document control
    • Automated training task deployment
  • Quality event management
    • Site monitoring
    • Protocol deviation management
    • Clinical CAPA management
  • Audit management (study, sites, vendors, etc.)
  • Training management (GCP, protocol)
  • Risk management (reporting, analytics, risk-based processes, etc.)
  • Clinical Software Process Diagram

    MasterControl CQMS Summary


    The MasterControl CQMS is a complete, well thought out, integrated set of solutions designed to address all of the document, task, process, quality, audit, and training needs throughout the life of a clinical study. The MasterControl CQMS increases efficiency and reuse of information while streamlining the processes and tasks that must be executed by internal and external users playing a role in your clinical trials.


    Clinical Management Challenges

    Clinical Management Solution




    Difficulty managing the high volume of documents that make up a clinical trial master file.
    The MasterControl TMF Reference Model JumpStartâ„¢ configuration is based on the DIA Reference Model. Using this model increases efficiency and provides a central location for all required TMF documents.



    Transferring high volume batches of information and content to and from various sources (i.e., internal, CRO, sponsors and clinical sites).
    MasterControl provides various methods for batch importing and exporting of content to and from the clinical management system to facilitate the relationship between sponsors and CROs.



    Management of all of the documents, tasks, and processes during the life of a clinical trial can be overwhelming.
    The MasterControl TMF project management capability in the clinical management software allows a clinical project lead to manage all activities of a clinical study with automated task reminders, milestones and updates as tasks are executed and promoted through various lifecycles.



    Managing site information, documentation and trial eligibility information from hundreds of sites for various clinical studies.
    With MasterControl, each clinical site's information can be linked, searched, and reported on. This information can include documentation, audit history, monitoring visits, study participation, document sharing and qualification information.



    Improving the quality of clinical data and reducing negative findings and open cases from audit findings.
    Through the use of integrated processes, audits and site information, quality tasks can be executed and closed out efficiently for increased compliance.



    Maintaining GCP compliance training records.
    With MasterControl's clinical management software, training can be customized by user role and methods used (ad hoc, virtual class, etc.) and administered with proficiency tools such as questionnaires, tests, and quizzes. Training tasks can be audited and set for automatic scheduling.


    For More Information on MasterControl's Clinical Quality Management Software Systems

    For more information about our clinical management software systems and jumpstart options, please feel free to contact a MasterControl representative.