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 JumpStart™ 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 about our clinical management software systems and jumpstart options, please feel free to contact a MasterControl representative.