CTMS

Trial Interactive’s Clinical Trial Management System (CTMS) is a secure, cloud-based solution that enables the collection and management of trial-related data in a single location. TI CTMS provides the ability for clinical studies team members, such as study managers and CRAs, to plan, collaborate, and track clinical data with specific attention to monitoring requirements. This is the industry’s first CTMS with a modern user experience and a mobile-first interface. TI CTMS can help your organization:

  • Provide a single source of truth for all trial-related data and information, with an intuitive planning and tracking structure,
  • Track and view product, program, study, country, site, organization, contact, subject, and subject visit data in real-time,
  • Ensure quality with support for adjustable, best-practice CTMS workflows that ensure completion of critical trial requirements. Reduce risk by confirming that plans are followed per SOP with controls in place to prevent issues,
  • Track timeliness with KPI metrics dashboards that provide an integrated real-time view of Clinical Trial data,
  • Confirm a fully updated CTMS before inspections with quality oversight, periodic reviews, and operational checks,
  • Plan study-related activities such as site visits, communications, training, and other key trial Milestones with due dates and responsibilities using visit schedules and activity plan templates,
  • Manage trial-related documentation with a built-in Content Management System and integrated eTMF, along with many other offerings,
  • Support flexibly, company-specific workflows and SOPs with a full set of custom fields, record statuses, and field validation,
  • Improve quality through standardized business practices and record-keeping,
  • Provide trial insights through drill-down study and portfolio dashboards, and,
  • Streamline clinical processes to reduce costs.

Additional features of the Trial Interactive CTMS include:

  • A mobile visit report App that supports both iOS and Android, with support for questionnaires, activity tracking, CRA Reconciliation, training, document capture, and offline mode
  • Pre-defined, best-in-class CTMS Activity Plans for consistent trial execution and operational checks
  • Built-in Site and IRB correspondence tracking, Email capabilities to keep close track of all back-and-forth activity
  • Automatic Notifications, Alerts, and Reminders with emails and a daily digest
  • Standard and Ad-hoc reports that support all custom metadata fields and the ability to add columns to standard reports or fully customize
  • Full support for clinical data integrations, including EDC, Payments, and IXRS, either directly or through a technical partner. Fields may be pulled from EDC and included in CTMS reporting.
  • Well-developed classroom and lab training courses with an integrated LMS and eLearning for study and site training.
  • Simpler and less administrative: Assign ownership to Studies, Sites, and Countries with central admin optional. Study and Site owners may then fully manage the record types they own, inviting and revoking access by start and stop date and by role.
  • Track everything that is trial-related in the form of a configured set of activities with types and subtypes that may all have their own configured sets of fields and statuses.
  • Event, Activity, and Document Sharing
  • A Clinical Trial Management System can track all trial activities as well as the collection of documents and evidence that must ultimately be published to the eTMF. As site visits are completed, they result in final documentation that must be archived. Additionally, documents must often be associated with trial records for viewing and distribution to the study teams.
  • All site visits are configured in the CTMS to trigger Site Events that are sent directly to the eTMF. These Events may then trigger required documents and placeholder creation in TI.
  • Visit status changes can trigger Events, Required Documents, and Placeholders within Trial Interactive, including eTMF rooms but also Site Collaborate and the CTMS Collaborative Workspace.