Protocol-driven study setup, design, and lifecycle management across all phases.
The Study Management module is the central hub of the CTMS platform. It provides protocol-driven study setup with a structured workflow stepper that guides teams from study creation through protocol design, site selection, regulatory submission, activation, conduct, and closeout. Every study artifact is managed with full version control and audit trails. The module integrates with all other CTMS modules, serving as the single source of truth for study metadata.
Explore the module's workflow through interactive interface mockups showing each step of the process.
Create a new study with protocol details, phase classification, and therapeutic area assignment via guided workflow stepper.
Track study progress through each lifecycle stage with a visual stepper. Each stage has defined entry/exit criteria and required deliverables.
Study Created
Protocol Approved
Regulatory Submitted
Sites Activated
Enrollment Open
Study Conduct
Database Lock
Study Closeout
Comprehensive dashboard showing study health metrics, enrollment progress, site status, and key milestones at a glance.
Active Sites
42
+3 this month
Enrolled Subjects
1,248
67% of target
Open Queries
23
-5 this week
Milestones On Track
18/20
90%
How Study Management integrates with other CTMS modules in the platform.
Study metadata flows to site activation and monitoring
Study protocol defines enrollment criteria
Study timeline drives milestone planning
Protocol and amendments require approval workflows
Study documents linked to regulatory submissions
Study KPIs roll up to portfolio view