Veeva Study Startup Feature Checklist

Feature Checklist

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. 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 Veeva eTMF

• Shared workflows and data with Veeva CTMS in a single, unified environment

Site and Country Activation

• Country start-up templates and workflows for 45+ countries

• Role-specific 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

See a demo of the Veeva Study Startup Homepage