• TrackWise Software Solution for Preclinical and Clinical Quality Management

    CROs are gaining momentum as a major player within the healthcare space, driven by financial and risk mitigation pressures, as well as regulatory scrutiny. As pharmaceutical and biotechnology companies continue to outsource drug discovery and development, CROs will continue to grow and have a need for enterprise clinical quality management technologies like TrackWise to manage all critical quality and compliance processes using a single, centralized system.

    The need to measure and ensure quality is vital throughout all aspects of the preclinical and clinical trial process. TrackWise enterprise quality management software provides a flexible and configurable platform for tracking and managing quality and compliance events to ensure that clinical research activities are continually measured, monitored and improved upon. As a single platform, TrackWise manages incidents, structured audit programs specifically tailored around preclinical and clinical trial execution, the associated corrective and preventive actions (CAPAs) and the analysis and approvals of changes such as protocol amendments, as well as trial registration, trial documentation and SOPs. The benefit of having quality and compliance procedures built into a single solution is that corrective and preventive actions as well as effectiveness checks can be easily tracked to ensure continual monitoring and improvement of the trial processes.

    TrackWise Preclinical and Clinical Quality Management: an end-to-end solution to track and manage all quality events and processes from preclinical, clinical and post-market activities.

    • Capture and manage OOS events from laboratory testing in GLP environments
    • Bring products to market faster and more efficiently with a holistic approach to the quality and regulatory processes that is critical for CROs to maintain a high level of quality service
    • Track clinical projects for sponsors on regulatory approval, ethics committee review, drug availability for studies and annual reporting to countries of submission
    • Manage protocols, studies, study sites, patients, monitoring visits and deviations in one comprehensive CTMS system 
    • Conduct internal and external audits of preclinical laboratories, clinical sites, suppliers, internal processes, etc. and manage the observations, CAPAs, and change control process in a closed-loop system
    • Track all licensed products in all marketed countries
    • QAU, QA, and QC assurance to adhere to standard operating procedures and compliance with GLP and GCP regulations, ICH guidelines, and the EU Clinical Trial Directives.
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