Clinical Trials Management Systems (CTMS)

Pharmaceutical, biotech, medical device manufacturers, and contract research organizations that implement integrated, electronic systems to manage their clinical trial processes gain the advantage of real-time tracking, effective control, and proven, repeatable processes. TrackWise by Sparta Systems’ Clinical Trials Management Systems (CTMS) enables companies to improve efficiency, integrity, and quality of clinical trials by automating and streamlining workflow processes and increasing the visibility of related tasks and data while improving compliance with clinical trial protocols, by supporting Good Clinical Practices (GCPs) and ensuring deviations and problems are tracked and responded to.

TrackWise provides organizations with a web-based solution that tracks, manages, and controls all clinical trials processes and tasks through a consolidated dashboard and desktop view. As a result, all shareholders, including senior management, trial managers, clinical operations and regulatory affairs have complete visibility into the current status of all trials, and related actions that are critical to the success of the program. 

Benefits:

• Streamlines the clinical trials process by consolidating tracking and management of all clinical trials activities into an easily accessible web-based system
• Increases resource utilization and collaboration by automating workflow processes and providing secure access to related information across multiple sites, studies, teams, and trials
• Reduces risk of lost records, incomplete items, and overdue tasks by eliminating paper and tracking items electronically
• Increases visibility of pending items through on-line reporting and dashboards
• Reduces administrative costs and duplicate efforts by leveraging TrackWise's 24/7 business rules engine, which automates manual procedures and escalates commitments based on priority, due date, and other criteria
• Improves the effectiveness of monitoring visits by utilizing on-line inspection checklists and questionnaires and tracking any violations or discrepancies through completion
• Improves the evaluation adverse events, minimize data entry errors, and streamline the creation and tracking of serious adverse events (SAE) reports
• Improves visibility of product safety issues and streamline the regulatory assessment and reporting process for SAEs
• Access distributed documentation through integrated document management technology, or by integrating to your existing document management system