Pharmaceutical, biotech, medical device manufacturers, and contract research organisations that implement integrated, electronic systems to manage their clinical trial processes gain the advantage of real-time tracking, effective control, and proven, repeatable processes. As a result, leading companies are implementing enterprise clinical trials management systems to improve the tracking and oversight of clinical trials processes.

TrackWise Clinical Trials Management Solutions

TrackWise software 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.

TrackWise provides organisations with a fully electronic, web-based tracking 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, finance, 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 programme.

In addition to reducing costs and accelerating time to market, TrackWise improves compliance with clinical trial protocols, supports good clinical practices (GCPs), and ensures deviations and problems are tracked and responded to.

TrackWise Clinical Trials Applications

• Study and protocol tracking
• Site status tracking
• Site initiation visits, close-out visits, audits, and other visits
• Violation, issue tracking
• Regulatory compliance monitoring
• Study manual development
• Protocol reviews
• Change control tracking
• Serious Adverse Event (SAE) collection and processing
• Assessing and complying with FDA reportability requirements
• Templates and checklists for compliance
• Ongoing submissions / communication with health authorities
• Action item management
• Billing

• Streamline the clinical trials process by consolidating tracking and management of all clinical trials activities into an easily accessible web-based system.
• Increase resource utilisation and collaboration by automating workflow processes and providing secure access to related information across multiple sites, studies, teams, and trials.
• Reduce risk of lost records, incomplete items, and overdue tasks by eliminating paper and tracking items electronically.
• Increase visibility of pending items through on-line reporting and dashboards.
• Reduce 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.
• Improve the effectiveness of monitoring visits by utilising on-line inspection checklists and questionnaires and tracking any violations or discrepancies through completion.
• Improve the evaluation adverse events, minimize data entry errors, and streamline the creation and tracking of serious adverse events (SAE) reports.
• Improve 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.