SimpleTrials CTMS - Seamlessly Integrated With TrialStat EDC
A Versatile CTMS Toolkit In One Simple Validated and Compliant Package
If you need a versatile, fullly validated and compliant CTMS at an affordable price, you can get it in one simple feature-rich package. SimpleTrials is the industry’s first on-demand, subscription-based CTMS for sites, vendors and sponsors.
Fully Integrated Features:
SimpleTrials CTMS provides the robust functionality needed to manage the most complex studies with the ease of use that busy teams require.
- Comprehensive and customizable startup tracker, integrated with your site list
- Site Startup Tracking manages activities from site selection through enrollment
- Integration with subject screening & enrollment records and calendar events (e.g. sync SIV dates, FPS and FPI dates)
- Screening, Screen Failure and Enrolled subject tracker with export capability
- Subject Visit Tracking, integrated with your protocol visit definitions and screen fail reasons
- Easily customize tracking views with custom columns and custom picklists for workflow needs
- Import external data sources quickly with import template with instructions
- Ability to integrate with external EDC systems
- Support for unscheduled visits
- Support for DIA reference models, SimpleTrials reference model, or build your own eTMF model
- Define site essential documents required for activation, study closure, and EC submission
- Ability to upload files directly to the CTMS with 21 CFR Part 11 compliant electronic signatures
- Manage tracking details such as common name, version, and status or build your own columns
- Expiration tracking with role-based and person-specific alerts
- Ability to track study-specific and other general documents by study
- Approved electronic visit reports (EVRs) and attachments automatically posted to eTMF
- Zip download available for posted files including organizational view
- Tracking and folder views plus document search feature for ease of navigation
- CTMS Reports for essential documents, folders, change history and custom tracking fields
- Calendar view displays comprehensive portfolio and study level activity at a glance with electronic visit report (EVR) insight
- Supports site visits (projected and actual), subject visits (projected and actual) and general company/team events (e.g., holidays)
- Supports export to Outlook (e.g. iCal)
- Integrated with the Site Visit Tracking, which provides workflow-based tracking of the visit report, confirmation and follow-up letters, and custom tracking needs
- Action items tracking for site visits and study team activities with alerts
- Includes CTMS Reports and KPI performance metrics for monitoring plan timelines
- 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 outputs
- Common metrics and reports supported for startup tracking, milestones, site visit reports, site essential docs, recruitment, contracts and payments
- Supports a variety of filtering, grouping and sorting options by report
- Custom columns in study views can be included
- Excel, CSV, PDF and HTML output supported
- User-defined templates at portfolio level for multi-study use
- Author and reviewer workflow for drafting through approval directly in app
- Document attachments for related essential docs and letters
- Integrated action items, deviations and subject content with system views
- In-application workflow notifications and email alerts
- Performance metrics and CTMS reports for authoring and approval
- Uses 21 Part 11 compliant e-signatures for author and approver and document attachments
- EVR integration and sync with subject records, protocol deviations, action items views
- Functionally validated with integration to eTMF, e-signature and open issue carry forward to next EVR.
- Task and Milestone tracking includes integrated Gantt chart
- Track targets, actuals and baseline dates
- Supports percent complete tracking, integrated alerts and export
- Set priority, responsible party and dashboard input records
- Import external data using detailed import template with instructions
- Project 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
- Comprehensive contact & organization management features at the portfolio level
- Visibility of sites, sponsors, vendors, IRBs, CROs
- Detailed views, search and export capabilities available
- Contact integration for study and site teams within studies
- Integration of the organizations to site, study team and vendor records within studies
- Global, site-specific and alternate address management for contacts and study materials
- Import contacts and organizations using import template with instructions
- 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
- In-application alerts for users to manage key events such as action items, visit reports, document expiration, study milestones
- 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)
- Customize tab view to set workflow for single or multiple studies
- Support to updating system picklist values throughout the application
- Select from available trackers for Admin, portfolio, study, site, and subject tracking -- create and place new trackers in the application
- Define templates at study level for country and multi-site association
- Supports multiple contracts per study and site
- Contract details include currency, item fee, overhead, holdback and subject visit associations
- Ability to manage partial, full, unscheduled and holdback payments
- Transparency into visit progress, data progress and fees
- Generate detailed invoices, view payment tracking history, and manage budgets with CTMS Finance Reports
- Use automations for invoicing of subject visits based on common rules
- Upload and manage documents associated with invoice activities
- Copy contract details, export views
Access the robust clinical trial management tools you need. SimpleTrials can adapt to the size of your projects and teams, from one study to a whole portfolio.
See TrialStat In Action
Request Your Personalized Demo. Our Clinical Team will organize a tailored demonstration of TrialStat based on your specific study requirements. You'll see first hand how TrialStats unified features, blazing speed, configurable features and comprehensive functionality will help you run more efficient and cost effective studies.