The simple, flexible Clinical Trial Management System (CTMS).

A Clinical Trial Management System (CTMS) is a software solution targeted for the Life Science industry.  CTMS is commonly used to manage processes and large amounts of data involved with clinical trial management and clinical study management.

A typical CTMS maintains and manages the planning, preparation, performance, and reporting of clinical trials, with an emphasis on keeping up-to-date contact information for participants and tracking deadlines and milestones such as those for regulatory approval or the issue of progress reports.

In some cases, a CTMS may also provide data to a business intelligence system, which acts as a digital dashboard for trial managers.

Product Overview

  • Easy to use, flexible, customizable
  • Runs in standard web browsers
  • Supports large, interdisciplinary global teams or small studies and teams
  • Portable for next study
  • Information available 24/7
  • Well defined user groups - includes internal and external users, multiple departments and external vendors
  • One system for both blinded and unblinded user types
  • Multi-study and portfolio management within one system

Product Features


Portfolio and Study Management

  • Consolidated views across studies with data import support for investigators, sites, and contacts 
  • Calendar visibility for events scheduled within each study and by team member
  • Dashboards show portfolio and summary data points and visualizations by study, region, country and monitor with download capability
  • Critical information such as subject visit schedule, CRA monitoring frequency, study milestones, protocol violations and study documents defined at the study level. 
  • Outsourcing tab provides a simplistic yet comprehensive overview of study components and identifies external vendors by task, country and primary point of contact.
  • Milestone management allows complete customization of the key dates for your study and country with visibility into at risk items, trending progress and date revisions.

Countries Planning and Management

  • Manage key milestones and target site/enrollment metrics for each study country compared with overall study milestones
  • Enrollment planning by country for target screening and enrollment as well as counts for actuals compared with subject screening and enrollment data.
  • Planning of screening and enrollment targets by month and establish targets for subjects to complete treatment
  • Data views allow quick comparison of target versus actuals and visualizations of differences with study planning metrics.
  • Insight into country level planning and actuals vs study level expectations

Site and Investigator Management

  • Site contact management including primary, alternate and site-specific details
  • Oversight of site selection and participation status across sites
  • Detailed enrollment planning and sub-study participation 
  • Tracking of key milestones for study startup from CDA through enrollment
  • Study document tracking and file uploading for site essential documents
  • Detailed startup tracking for EC submissions, communications and site documents
  • Contract and budget management including invoice generation, partial payments and histories

Subject Management

  • Tracking of subject progress in screening, scheduled to screen, screen failures and enrolled
  • Ability to support integration with external EDC/IWRS/IRT systems
  • Dashboard metrics and visualizations with recruitment and screen failures by site, and subject visit progress and download capabilities
  • Subject screening and enrollment tracking includes ICF date, protocol version, treatment status, and study status
  • Visit level tracking includes visit window projections, visit status, and integration with subject payments
  • Protocol deviations and exceptions tracking and trending

Study Team Management

  • Team roster with CRA-site assignments, start/stop dates on project, roles and titles
  • Ability for authorized users to trigger team member account invitations
  • Supports global team member collaboration with built in study view settings and country and site assignments appropriate to given person/team.
  • Action item tracking by functional area with assignment to team members and ability to export
  • Study document development tracking area for monitoring plans, AE plans, etc.
  • Training status by team member for defined study and team procedures

CRA Workspace

  • Fully integrated site visit calendar for CRA visit planning and insight into visit report authoring progress
  • eVisit Report (EVR) authoring and approval features directly in the system 
  • Supports site visit report tracking for EVRs and external reports with related visit letter and document upload features
  • Cumulative action item views and tracking supports content from EVRs as well as items directly added via the tab
  • Integrated alerts for action items and electronic visit reports 
  • Integrated TMF repository for approved EVRs and attachments
  • Tools for CRA visits including interactive site map and shared repositories 

Regulatory Affairs and Safety

  • Define and plan submission timelines by country for up to 3 regulatory agencies and submission content
  • Track expected regulatory agency approvals by country per defined submission timelines and submission actuals 
  • Define essential document package details by document including country-specific items and desired document numbering and folder structures
  • View uploaded site essential document files in organized file folder structures per definitions
  • File upload and tracking support for IND Safety reports, agency submission tracking and repositories for standard forms and progress reports

Additional Details

  • Repositories: Limited access repositories throughout functional areas for files uploaded and content created within the application. 
  • Reports and Dashboards: SimpleCTMS supports a flexible reporting interface and dashboards to provide data summaries, charts and visualizations, and checklists. Ad hoc reports supported
  • Study Document bundle: Download all study level documents as a zip file with established folder structure
  • Data Export: Data exports allow download or email delivery of tracking views in common formats

Validated Hosting: Secure & Reliable

Please note that the Validated Hosting Plan is optional for SimpleCTMS.

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SimpleCTMS offers validated hosting by a validated hosting provider who provides a qualified server environment to store and process your data.

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The US-based 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. Our validated hosting provider provides best of class reliability, redundancy and high availability.


Platform: Application, Compliance & Quality

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Proven Platform

  • SimpleCTMS 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.
  • SimpleCTMS 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.


Feature Comparison between SimpleTrials & SimpleCTMS

Trial By Fire Solutions offers two CTMS products: