Screen captures of ClinPlus Clinical Trial Management System

1. ClinPlus CTMS The screens have been designed for easy navigation and consistency throughout the system. Easily move between the various areas with a click of the mouse. Most screens present summary information first, and allow the user to drill down for more detail. Access to projects, sites, menus and features is restricted using role-based security. The “My Favorites” feature allows users to add shortcuts to their most frequently used screens or reports onto the menu bar.

2. Configuration Options System configuration is easy for administrators and project managers. Default configuration choices are defined at the system level, but can easily be overridden at the project level.

3. Task Management A combination of manual and automated tasks is used to ensure that routine project steps are completed in a timely manner. Project Messages Create messages for team members to enhance project communication.

4. Project Management Overview A high-level snapshot of the key metrics used to manage clinical research projects. This screen provides managers with the key numbers that are used to determine the progress of a clinical research study.

5. Project Projections The system will use the existing enrollment and site startup data to estimate project enrollment completion dates. In this example, the rate of enrollment would have to almost double (from 0.50 to 0.92 subjects/site month) in order to achieve an on-time completion.

6. Project Events Project Events are used to track key milestones during the course of a clinical research project. Events are customized for each project.

7. Project Charts Charts are used to visually demonstrate trends in project data, such as Enrollment, Screening, Site Initiations and Site Visits. Data Import is used to import project data from other systems, such as EDC or IVRS.

8. Site Events Startup Events are used to manage the process of moving a Site through the various stages from Initial Contact through Site Initiation. Study Events maintain a history of key events during the study.

9. Site Visits All types of project-specific site visits can be tracked. Associated documents such as confirmation and follow-up letters and trip reports can be uploaded and shared with the project team.

10. Site Documents Track the status of essential documents for each site. Optionally, sites or CRAs can upload electronic copies of each document to share with team members.

11. Integrated Blogs Blogs (or “Weblogs”) are used to manage and share communications, issues, or messages to all members of the project team. Blogs are available at the Project, Site, and Subject level, and can also include customizable Tags for easy searching and reporting. Team members can add comments to each blog entry.

12. Payments to Investigators Payments to Investigators are calculated for each Subject Visit, and can be set for either manual or automatic approval. Multiple payment budget amounts can be defined for each Investigator based on the subject’s gender, group, or protocol amendment.

13. Financial Overview Financial overview screens display summaries of all key finance metrics, such as total payables, pending payments, and holdback amounts.