SimpleTrials is the only on-demand CTMS, with subscription plans starting at $35/month.  With on-demand subscriptions, you can subscribe directly via this website, with no long term commitment.  See our Pricing and Plans.


Product Features

Site startup and subject tracking

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.
SimpleTrials calendar and monitoring

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.
SimpleTrials ad-hoc reporting engine

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.
SimpleTrials planning and milestones

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.
SimpleTrials contacts and organizations

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.
SimpleTrials real time study analytics and dashboards

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.
SimpleTrials custom fields and trackers

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).

Available Now: Site Contracts and Payments & Electronic Visit Reports!


Coming Soon

Product Roadmap includes IRB/EC Tracking; Protocol Deviations; Multi-language Support


Validated Hosting: Secure & Reliable

SimpleTrials Validated Hosting is provided by ByteGrid

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SimpleTrials is hosted in ByteGrid’s premier data center in Silver Spring, MD, which provides a validated & qualified server environment for SimpleTrials & your data.

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The Silver Spring data center has achieved the following: SOC 2 Type II, GSA ISC Level IV, PCI DSS, FISMA, ISO 27001, ISO 9001,EHNAC accredited, GxP & HIPAA Qualified.

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Firewalls, state of the art virus and intrusion protection, server monitoring, data encryption and physical security all ensure your clinical data is protected with the highest levels of security.

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Full system backups are performed nightly and stored in redundant geographical locations. ByteGrid provides best of class reliability, redundancy and high availability.


About ByteGrid

  • ByteGrid is a trusted and leading provider of highly secure and compliant solutions serving the most demanding requirements of enterprise and government customers, including those in the Life Sciences and Health IT industries.

  • ByteGrid focuses on technology solutions and services that ensure that regulatory expectations are always met.

  • ByteGrid’s robust, scalable and highly secure Hosting and Compliance Services are delivered from an interconnected national platform of validated Tier 3 / 4 data centers.

  • ByteGrid is one of the few HIPAA compliant hosting providers to achieve EHNAC accreditation.

Platform: Application, Compliance & Quality

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Proven Platform

  • SimpleTrials supports the controls needed for 21 CFR Part 11 Compliance.
  • Designed by clinical experts, built by technology experts-- based on a decade of experience focusing on CTMS applications.
  • SimpleTrials uses the latest, proven web application & database technologies. All personnel are based in the United States.
  • Trial By Fire Solutions has experience integrating CTMS data with 3rd party EDC, IWRS and TMF systems.
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Backed by a quality system using validated software processes:

  • Agile software development life cycle is used for controlled and efficient system building and maintenance.
  • Requirements and design specifications are formally documented.
  • Qualifications are authored with traceability to requirements.
  • Qualification execution results are recorded with objective evidence.
  • Risk analysis and mitigation are performed and documented.
  • Formal change control procedures govern system updates.


Support & Subscription

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Expert CTMS Support

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


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The Simplest Subscription Model Available

  • New customers can subscribe and start using the system anytime via our online subscription page.
  • No long term commitment required; discounts are offered for pre-paid annual subscriptions.
  • Subscription plans have a flat monthly or annual fee based on the number of users and studies you need.
  • There are no hidden fees or per-study charges.



Feature Comparison between SimpleTrials & SimpleCTMS

Trial By Fire Solutions offers two CTMS products:

SimpleTrials comparison grid