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

Homepage_15May2018.jpg
  • 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

studymilestones.jpg

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.
countriesenrollment.jpg

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
 
sitedetails.jpg

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
subjectsenrollment.jpg

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
 
teamtraining.jpg

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
CRAworkspace.jpg

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 
 
regdocs.jpg

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
additionaldetails.jpg

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.

SimpleTrials icon

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

SimpleTrials icon

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.

SimpleTrials icon

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.

SimpleTrials icon

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.

light-gray.png

Platform: Application, Compliance & Quality

SimpleTrials icon
 

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.
SimpleTrials icon
 

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:

SimpleTrials_ProductComparison_Apr2018.jpg