Site Startup & Subject Tracking
- Comprehensive and customizable startup tracker, integrated with your site list.
- Site Startup Tracking manages activities from site selection through enrollment.
- Screening, Screen Failure and Enrolled subject tracker.
- Subject Visit Tracking, integrated with your protocol visit definitions.
- Support for unscheduled visits.
Documents & eTMF
- Support for DIA reference model, as well as SimpleTrials reference model or build your own.
- Define documents required for activation and study closure.
- Ability to upload files directly to the CTMS with electronic signatures.
- Expiration tracking with alerts.
- Ability to track study specific and other general documents by study.
Calendar & Monitoring
- Monthly and 8 week calendar view displays comprehensive portfolio and study level activity at a glance.
- Supports site visits, subject visits and general company/team events (e.g. holidays).
- Supports projected and actual site & subject visits.
- Integrated with the Site Visit Tracking, which provides workflow-based tracking of the visit report, confirmation and follow-up letters.
- Action items tracking for site visits and study team activities with alerts.
Ad-hoc Reporting Engine
- Reporting interface allows custom reports across functional areas of the CTMS.
- Standard (default/canned) report definitions are provided so you can generate reports immediately.
- Custom reports can be defined and saved using a simple interface.
- Reports allow multi-study or single-study data, with a variety of filtering options.
- Excel, CSV, PDF and HTML output supported.
Planning & Milestones
- Task and Milestone tracking includes integrated gantt chart.
- Track targets, actuals and baseline dates.
- Project-light features include definition of predecessors and lag between tasks.
- Use the default milestones and tasks or create your own set.
- Copy your milestones and tasks between studies for consistency across your program.
Contacts & Organizations
- Comprehensive contact & organization management features at the portfolio level.
- Integrate the contact list into your study team and site team definitions within studies.
- Integrate the organization list into your site, study team, and vendor tracking within studies.
- Global, site specific and alternate address management for contacts and study materials.
Real Time Study Analytics & Dashboards
- Dashboard charts provide visualizations of study performance like site startup and enrollment activities.
- Basic study analytics, like target vs. actual number of countries, sites, screens and enrolled subjects are visible for quick reference.
- Charts can be exported for use in external documents and presentations.
Custom Fields and Trackers
- Users can directly customize trackers by adding custom fields (no programming necessary).
- Ability to re-order tracker columns and hide system default columns.
- Ability to set data type (e.g. text vs. date) and style of custom columns (e.g. color).
Product Roadmap includes Site & Sponsor Payments; Electronic Visit Reports; IRB/EC Tracking; Protocol Deviations; Multi-language Support