Vault Study Startup Features
Explore Vault Study Startup Capabilities
As trials and protocols increase in complexity, moving beyond Excel trackers to manage study start-up processes becomes critical to ensure on-time site activations. Not all study start-up applications are created equal, so it’s important to ensure you’re investing in a full-featured solution. From event-driven automation that triggers downstream updates to unification with other clinical systems, this checklist highlights all of the features you should look for in a study start-up application to optimize start-up activities and get to First Patient First Visit faster.
Study Setup and Planning
- Milestone durations
- Predictive planning
Site Qualification and Selection
- Investigator, organization, and person database
- Site identification workflow
- Site identification searching and matching
- Site qualification and selection workflow
- Feasibility surveys
Essential Document Collection
- Site package distribution and document collaboration
- Document management
- Site and investigator document re-use
- Auto-filing in Vault eTMF
- Shared workflows and data with Vault CTMS in a single, unified environment
Site and Country Activation
- Country start-up templates and workflows for 45+ countries
- Role-specific Vault Study Startup homepages
- Critical path management
- IRB/EC submission management
- Milestone auto-completion
- Ad-hoc events and milestones
- Contract and budget negotiation workflow
- Budget tracking
- Cycle time metrics
Site Greenlight Review and Approval
- Site activation progress tracking
- Greenlight package approval workflow
Reporting and Visibility
- Metrics and cycle time tracking
- Configurable reports and dashboards
Application Security and Access Controls
- Granular profile and role permissions
- Object-level and workflow security