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 & 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 & 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).
 
 

Coming Soon

Product Roadmap includes Site & Sponsor Payments; Electronic Visit Reports; IRB/EC Tracking; Protocol Deviations; Multi-language Support

 
 

Validated Hosting: Secure & Reliable

 
 

Trial By Fire Solutions is proud to partner with ByteGrid for validated hosting of SimpleTrials.
 

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

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.

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.

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.
 
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Platform: Application, Compliance & Quality

 

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.
 

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

 

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.

 

 

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.

 

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Feature Comparison between SimpleTrials & SimpleCTMS

Trial By Fire Solutions offers two CTMS products: