CTMS component of StudyManager SE

The CTMS component of StudyManager SE gives users a common set of Web-based tools for managing critical aspects of clinical trials and easily sharing data.  Monitors, project managers, executive managers, and site personnel can get their work done in a fraction of the time usually required to manage multi-site clinical studies.

Here are the main features of the CTMS component:

• Configure Studies and Sites:  Configure and manage study definitions so users can quickly and securely access critical information about their studies online, rather than having to search through documentation.  Track which study sites are participating in the study, study and site progress, study personnel, or add your own custom fields to track any study-related data you want.
  
  
• Create Monitoring Plans and Site Reports:  Build monitor plans based on study requirements, and your SOPs.  You can include visit checklists for every site visit to ensure that monitors perform all the required activities.  Monitors then use these templates to create electronic trip reports that can be reviewed online.  Findings and issue resolutions can then be tracked electronically, ensuring that all issues are resolved.
  
  
• Track Subjects:  Use a highly intuitive user interface to track subject enrollment, status, protocol visits, and other information.  This module can be used at the headquarters office or can easily be used by clinical staff at the investigative sites over a secure Web connection.  Very little site training is required.
  
  
• Track Personnel:  Store and search data about all personnel associated with your organization, or with the investigative sites.  You can create any number of custom fields to store and search any type of personnel information you need.
  
  
• Report:  Use any of our pre-built, customizable report templates or create your own custom report templates using any third-party reporting tool.  Since the StudyManager SE database is open, authorized system administrators can access the database tables directly to query information or create report of virtually any complexity.
  
  
• Create and View Study Dashboards:  Show study progress across all sites in one convenient screen.  You can create and save any number of custom views  that will instantly show enrollment progress, site status, and other information.