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