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.
- 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
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
- 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
- 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
- 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