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

Features

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