Features

SimpleTrials’ versatile CTMS keeps everything you need — worksheets, documents, calendars, contacts, schedules, payments, milestones and more — in one feature-rich, scalable package all while maintaining compliance every step of the way. It’s the industry’s first on-demand, subscription-based CTMS for sites, vendors and sponsors.

Plans start at $35/month. With SimpleTrials, you subscribe, sign in and get to work with a comprehensive toolkit with no long-term commitments.



Product Features

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.  


Site Startup and 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
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Documents and 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 and Monitoring

  • Monthly and eight-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 and 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
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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 and 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
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Contacts and 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 and 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
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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)

Site Contracts and Payments

  • Define templates at study level for 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 and unscheduled payments
  • Transparency into visit progress, data progress and fees
  • Generate detailed invoices, view payment tracking history, CTMS Finance Reports
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Electronic Visit Reports

  • 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
  • In-application workflow notifications and email alerts
  • Performance metrics and reports for authoring and approval
 

Ready for a comprehensive CTMS toolkit?

Expert CTMS Support

  • All users receive customer support from our internal team of CTMS experts.
  • Help tips guide you as you go.
  • Comprehensive user manual is available.
  • Online video training is accessible to all users.
  • Live training and professional services are available at additional cost.
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Feature Comparison Between SimpleTrials and SimpleCTMS

To meet your clinical trial management needs, Trial By Fire Solutions offers two CTMS products:

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