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 $124/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
Site Startup Screen Shot v1.png


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


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


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


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


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.

Feature Comparison Between SimpleTrials and SimpleCTMS

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