What is a CTMS, and how can it help?

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

View details of Study Startup Tracking features.

Study Dashboard shows summary data points and data visualizations. Tab-based layout with intuitive, modern look and feel. (click to enlarge)

Study Dashboard shows summary data points and data visualizations. Tab-based layout with intuitive, modern look and feel. (click to enlarge)

Portfolio & Study Management

  • Simple study chooser login and dashboard with side-by-side metrics for program needs.
  • Critical metadata are defined for drugs, programs, and indications
  • Dashboards show summary data points and visualizations
  • Critical information such as CRF collection, CRA monitoring frequency, protocol visit frequency and protocol violations defined at the study level. Team training requirements defined by role and item.
  • 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.  Change tracking allows visibility into at risk items, and trending provides an indication of progress for each study country. 
Study Milestones screenshot shows customizable view with country level trending (click to enlarge).

Study Milestones screenshot shows customizable view with country level trending (click to enlarge).

Country Planning and Management

SimpleCTMS enables you to manage milestones and target site/enrollment metrics for each study country. Milestone trending visualizations provide a simple indicator of countries that are under-performing. Our data views allow quick comparison of target versus actuals.

Site and Investigator Management

  • Site contact information, selection and participation status
  • Enrollment planning and sub study participation
  • Key milestones , FPI tracking and site start-up details
  • Key regulatory document details and tracking
  • IRB/IEC(s) meeting schedule and approval detail
  • Contract and budget detail, tracking and payments
  • Inventory management
The Site Details tab includes a detailed record of the site, including CRA assignments and site status.

The Site Details tab includes a detailed record of the site, including CRA assignments and site status.

The FPI Planning tab includes a side-by-side display of agency review status, central ethics committee approval and supplies status.

The FPI Planning tab includes a side-by-side display of agency review status, central ethics committee approval and supplies status.

Subject Management

  • Screening and screen failure tracking and trending
  • Study and sub study enrollment tracking with visit projections, treatment, and study status tracking
  • Protocol deviations and exceptions tracking and trending
  • Data planning with CRFs completion status and data retrieval status and projections
  • Inventory management by subject 

Study Team Management

SimpleCTMS allows you to manage what is critical for successful team work with global teams.

  • Team roster with CRA-site assignments, start/stop dates on project, roles and titles
  • Study document development tracking area for monitoring plans, AE plans, etc.
  • Training status by team member (SOPs/Plans/Guidelines)
  • Limited access repository tabs for Sponsor and Regional Project Managers
  • Action items and workflow planning areas
Manage your study teams quickly and easily by role, site assignment and start/stop dates on project.

Manage your study teams quickly and easily by role, site assignment and start/stop dates on project.

CRA Workspace

  • Dashboard with key metrics
  • Fully integrated site visit calendar for CRA visit planning and manager resource planning
  • Key site visit details including visit report status, subject participation status and CRF monitoring & retrieval
  • Action Items for self, reviewer or sponsor input
  • Repositories for shared CRA tools and visit reports
  • Interactive site map
SimpleCTMS CRA workspace

Supply Chain Management

  • High level dashboards and inventory planning by item type
  • Restricted user access as needed for blinded study medications
  • Identification of supplies to be provided by item type, responsible supplier and required lead time
  • Definitions of kit/product types by region/country/product
  • Tracking - raising item requests, courier info, status
  • Proforma document repository - internal/external access

Regulatory Affairs & Safety

  • Utilize the SimpleCTMS Regulatory tab to complement country startup activities and study startup timelines. Items include regulatory submission planning by agency, country, and document type. Track planned versus actual approvals at country and site level and use document repositories as needed. Proactively define regulatory document package requirements for site activation by country.
  • The SimpleCTMS Safety tab provides secure repositories to store and access IND Safety Reports by type and date, individual SAE reports and related queries, and weekly status reports. CRAs and Regulatory Associates can quickly identify new SUSARs reports and plan and track required agency submissions and use built in dashboards as a guide.

Data Management

  • Customizable milestones and built-in trending to visualize "at risk" items
  • Dashboards for high level planning activities
  • Limited access areas (Sponsor or 3rd party vendor)
  • Structured yet customizable repositories for template forms, processes and status reports
  • CRF Tracking integration of items retrieved by CRAs and received for data entry
  • Secured repositories for imaged CRFs, supplemental data items, data queries and listings

Additional Details

  • Document Sharing: SimpleCTMS uses limited access repositories throughout functional areas. For example, CRAs can access regulatory documents for their assigned sites and regulatory submissions specialists can access country specific documents for submissions.
  • Reports and Dashboards: SimpleCTMS supports a flexible reporting interface and dashboards to provide data summaries, charts and visualizations, and checklists.
SimpleCTMS additional details
  • User Groups and Security: SimpleCTMS provides flexible, customizable user groups to allow the right level of access to the right users.
  • Data Imports, Exports and APIs: The CTMS is often one of many systems in your eClinical suite.  We offer many ways of getting data into and out of the CTMS.  This includes user-driven import and export, and secure, automated system interfaces (APIs).
  • Flexibility and Ease of Use: SimpleCTMS is intuitive by design. Our product allows each user to customize his or her views and settings to display the information that is most relevant to them.
  • 21 CFR Part 11 Support: SimpleCTMS provides the technical controls needed for compliance, including user account controls, audit trail, data transfer controls and electronic signatures.
  • Complete 24 x 7 Customer Support: Just in case you need it, we provide 24x7 phone and email support.