Key Features/Benefits

  • Provides centralized end-to-end management of all clinical trial activity
  • Improves effectiveness of site monitoring 
  • Removes reliance on manual processes to ensure compliance with regulatory submission processes
  • Increases control with real-time status, tracking, metrics and KPIs
  • Streamlines clinical operations including CRF, document and subject visit tracking
  • Multiple data dashboards and reporting capabilities across different levels of the data
  • Advanced report scheduler can generate reports at specified times / intervals and automatically distribute reports
  • Robust integration capabilities via pre-built connectors and web services for integration with third-party systems
  • Full-featured study planner including enrollment analyzer
  • Embedded TMF functionality 
  • Comprehensive monitoring module with online / offline capabilities
  • Advanced contract management and payment functionality

Background

Every clinical trial requires close collaboration between many departments, which often results in the deployment of a wide range of supporting systems that are rarely integrated.  Yet the deployment of diverse clinical systems from different vendors, using different technology, can create a disconnect within clinical development, making it difficult to ensure compliance and achieve a complete overview of all clinical activity and progress.

LifeSphere CTMS™ - Clinical Trial Management System

LifeSphere CTMS is a comprehensive and versatile clinical trial management system (CTMS) that enables life science organizations to plan, track and control all tasks and activities related to the set-up, conduct and closeout of clinical trials. Fully configurable and offering capabilities beyond the limitations of a traditional CTMS, LifeSphere CTMS provides a unique opportunity to replace many legacy systems to deliver a clinical operations platform that offers a complete oversight over all clinical trial activity.

Automated Study Set-Up

Study set-up is facilitated by automating many core activities such as study planning, site assessments, investigator selection, enrollment planning, document distribution and site visit planning. A library of global and protocol-specific templates for visits, study plans and documents ensure new studies can be set up quickly and consistently.

Streamlined Study Conduct

Study conduct is streamlined with an impressive array of powerful functionality. CRAs can track the status of all site documents, track patient visits, perform site monitoring, track investigator payments and route completed visit reports through an automated, workflow-driven review-and-approval process.

The powerful site monitoring planner integrates event-based planning into configurable monitoring plans, which can also be linked with most EDC systems. Study managers can track all regulatory submission activity, monitor the progress of every key milestone and check study progress at every level of the trial hierarchy via the enterprise dashboard, which delivers key metrics and KPIs.

Thorough Study Closeout

Study teams can store all final documents in the embedded electronic trial master file (eTMF) and can track the completion of milestone activities and tasks, ensuring they are achieved before the study closes. All reports can be exported into different file formats to aid in independent audits as well as the study closeout process.

clinical trial data management software